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Onsior for Dogs & Cats

Onsior for Dogs & Cats
Cat 6mg » Priced per Tablet
Solution for Injection » 20mg/ml

  • Cat 6mg » Priced per Tablet £0.70
  • Dog 5mg » Priced per Tablet £0.49
  • Dog 10mg » Priced per Tablet £0.70
  • Dog 20mg » Priced per Tablet £0.89
  • Dog 40mg » Priced per Tablet £1.19
  • Solution for Injection » 20mg/ml £53.50

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Description

Onsior is one of the safest medications of its type for use in dogs and cats. For dogs it is used primarily to treat osteoarthritis (degenerative joint disease). Onsior reduces pain and stiffness in the joints of affected dogs, increasing their mobility and enjoyment of exercise. Onsior can also be an effective treatment for the relief of pain and inflammation of other causes in both dogs and cats. Its effects are directed particularly at the causes of the inflammation meaning that side effects are much less likely to occur.

Onsior should not be given to patients which are dehydrated, or if underlying kidney or gastro-intestinal conditions might be present. Treatment should be supended if vomiting or diarrhoea are seen.

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Medication Datasheets

Cat 6mg » Priced per Tablet

Onsior 6mg tablet for cats

Qualitative and quantitative composition

Each tablet contains:

Active substance:

Robenacoxib 6 mg.

For the full list of excipients see section pharmaceutical particulars.

Pharmaceutical form

Tablet.

Round, beige to brown tablets with imprints "NA" on one side and "AK" on the other side.

Clinical particulars

Target species

Cats

Indications for use, specifying the target species

For the treatment of pain and inflammation associated with acute or chronic musculo-skeletal disorders in cats.

For the reduction of moderate pain and inflammation associated with orthopaedic surgery in cats.

Contraindications

Do not use in cats suffering from gastrointestinal ulceration.

Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Do not use in pregnant and lactating animals.

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.

Use in cats with impaired cardiac, renal or hepatic function or in cats that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these cats require careful monitoring.

Response to long-term treatment should be monitored at regular intervals by a veterinary surgeon. Clinical field studies showed that robenacoxib was well-tolerated by most cat for up to 12 weeks.

Use this veterinary medicinal product under strict veterinary monitoring in cats with a risk of gastrointestinal ulcers, or if the cat previously displayed intolerance to other NSAIDs.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after use of the veterinary medicinal product.

In small children, accidental ingestion increases the risk for NSAID adverse effects. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

In pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus.

Adverse reactions (frequency and seriousness)

Mild and transient diarrhoea, soft faeces or vomiting were commonly reported in clinical trials with treatment up to 6 days. In very rare cases, lethargy may be observed. Vomiting was very commonly reported, and anorexia, diarrhoea, lethargy and inappropriate defecation were commonly reported in field studies with treatment up to 12 weeks in cats with chronic musculo-skeletal disorder, with similar frequencies in the Onsior and placebo treated cats.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

Use during pregnancy, lactation or lay

Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats used for breeding.

Interaction with other medicinal products and other forms of interaction

Onsior must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and, accordingly, a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.

Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring. In healthy cats treated with or without the diuretic furosemide, concomitant administration of Onsior with the ACE inhibitor benazepril for 7 days was not associated with any negative effects on plasma aldosterone concentrations, plasma renin activity or glomerular filtration rate. No safety data in the target population and no efficacy data in general exist for the combined treatment of robenacoxib and benazepril.

As anaesthetics may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.

Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity.

Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.

Amounts to be administered and administration route

For oral use.

Give either without food or with a small amount of food. Onsior tablets are easy to administer and well accepted by most cats. The tablets should not be divided or broken. 4 The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2.4 mg/kg. The following number of tablets should be given once daily at the same time every day:Body weight (kg) Number of tablets 2.5 to 61 tablet6 to 122 tablets

Body weight (kg)

Number of tablets

2.5 to 6

1 tablet

6 to 12

2 tablets

Acute musculoskeletal disorders treat: for up to 6 days.

Chronic musculo-skeletal disorders: Duration of treatment should be decided on an individual basis.Please refer to Special Precautions For Use.

A clinical response is normally seen within 3-6 weeks. Treatment should be discontinued after 6 weeks if no clinical improvement is apparent.

Orthopaedic surgery: Give as a single oral treatment prior to orthopaedic surgery. Premedication should only be carried out in combination with butorphanol-analgesia. The tablet(s) should be administered without food at least 30 minutes prior to surgery.

After surgery, once daily treatment may be continued for up to two further days. If necessary, additional analgesic treatment with opioids is recommended.

The interchangeable use of Onsior tablets and Onsior solution for injection has been tested in a target animal safety study and was shown to be well tolerated by cats.

For cats, Onsior solution for injection or tablets may be used interchangeably in accordance with the indications and directions of use approved for each pharmaceutical form. Treatment should not exceed one dose (either tablet or injection) per day. Please note that the recommended doses for the two formulations are different.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In healthy young cats aged 7–8 months, oral robenacoxib administered at high overdoses (4, 12 or 20 mg/kg/day for 6 weeks) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.

In healthy young cats aged 7- 8 months, oral robenacoxib (Onsior tablets) administered at overdoses of up to 5 times the maximum recommended dose (2.4 mg, 7.2 mg, 12 mg robenacoxib/kg bodyweight ) for 6 months was well tolerated. A reduction in body weight gain was observed in treated animals. In the high dose group kidney weights were decreased and sporadically associated with renal tubular degeneration/ regeneration but not correlated with evidence of renal dysfunction on clinical pathology parameters.

The interchangeable use of Onsior tablets and Onsior solution for injection in 4-months old cats at overdoses of up to 3 times the maximum recommended dose (2.4 mg, 4.8 mg, 7.2 mg robenacoxib/kg orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg subcutaneously) resulted in a dose-dependent increase of sporadic oedema at the injection site and minimal to mild subacute/chronic inflammation of the subcutaneous tissue. A dose-dependent increase in the QT interval, a decreased heart rate and corresponding increased respiratory rate were observed in laboratory studies. No relevant effects on body weight, bleeding time or evidence of any gastrointestinal, kidney or liver toxicity were observed.

In overdose studies conducted in cats, there was a dose-dependent increase in the QT interval. The biological relevance of increased QT intervals outside of normal variations observed following overdose of robenacoxib is unknown. No changes in the QT interval were observed after single intravenous administration of 2 or 4 mg /kg robenacoxib to anaesthetised healthy cats.

As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised cats. There is no specific antidote. Symptomatic supportive therapy is recommended and should consist of administration of gastrointestinal protective agents and infusion of isotonic saline.

Withdrawal periods

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs.

ATCvet code: QM01AH91.

Pharmacodynamic properties

Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g. in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme which is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.

In the in vitro whole blood assay in cats, the selectivity of robenacoxib was approximately 500 fold higher for COX-2 (IC50 0.058 μM) as compared to COX-1 (IC50 28.9 μM). At a dose of 1–2 mg/kg body weight, robenacoxib tablets produced a marked inhibition of COX-2 activity in cats and had no effect on COX-1 activity. In an inflammation model in cats, robenacoxib injection had analgesic, anti-inflammatory and anti-pyretic effects and a rapid onset of action (0.5 h). In clinical trials in cats, robenacoxib tablets reduced pain and inflammation associated with musculoskeletal disorders and reduced the need for rescue treatment when given as premedication in case of orthopaedic surgery, in combination with opioids. In two clinical trials in (mainly indoor) cats with chronic musculo-skeletal disorder, robenacoxib increased the activity and improved subjective scores of activity, behaviour, quality of life, temperament and happiness of the cats. Differences between robenacoxib and placebo were significant (P<0.05) for the client specific outcome measures, but did not reach significance (P=0.07) for the feline musculoskeletal pain index.

In a clinical study, 10 of 35 CMSD cats were assessed to be significantly more active when treated with robenacoxib for three weeks compared to these same cats when they received a placebo treatment. Two cats were more active when given placebo and for the remaining 23 cats no significant difference in activity could be detected between robenacoxib and placebo treatment.

Pharmacokinetic particulars

Absorption

After oral administration of robenacoxib tablets at approximately 2 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1,159 ng/ml and an AUC of 1,337 5 ng·h/ml. Co-administration of robenacoxib tablets with one third of the daily food ration produced no change in Tmax (0.5 h), Cmax (1,201 ng/ml) or AUC (1383 ng·h/ml). Co-administration of robenacoxib tablets with the entire daily food ration produced no delay in Tmax (0.5 h), but a lower Cmax (691 ng/ml) and a slightly lower AUC (1,069 ng·h/ml). The systemic bioavailability of robenacoxib tablets was 49% without food.

Distribution

Robenacoxib has a relatively small volume of distribution (Vss 190 ml/kg) and is highly bound to plasma proteins (more than 99%).

Biotransformation

In cats robenacoxib is extensively metabolised by the liver. Apart from one lactam metabolite, the identity of other metabolites is not known in cats.

Elimination

Robenacoxib is rapidly cleared from blood (CL 0.44 L/kg/h) with an elimination t1/2 of 1.1 h after intravenous administration. After oral administration of tablets, the terminal half-life from blood was 1.7 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood. Robenacoxib is excreted predominantly via the biliary route (~70%) rather than via the kidneys (~30%). The pharmacokinetics of robenacoxib do not differ between male and female cats.

Pharmaceutical particulars

List of excipients

Yeast powder

Cellulose, microcrystalline

Povidone (K-30)

Crospovidone

Silica, colloidal anhydrous

Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years.

Special precautions for storage

Store below 25 °C.

Nature and composition of immediate packaging

Cardboard box containing 1, 2, 5 or 10 Alu/Alu blisters. Each blister contains 6 tablets.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Holder (if different from distributor)

Elanco Europe Ltd.

Lilly House, Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

Marketing Authorisation Number

EU/2/08/089/001-003

EU/2/08/089/021

Date of the first authorisation or date of renewal

Date of first authorisation: 16/12/2008. Date of last renewal: 08/11/2013.

Date of revision of the text

August 2018

Any other information

Legal category

Dog 10mg » Priced per Tablet

Onsior 5 mg, 10 mg, 20 mg, 40 mg flavoured tablets for dogs

Qualitative and quantitative composition

Each tablet contains:

Active substance:

5 mg tablets: Robenacoxib 5 mg10 mg tablets: Robenacoxib 10 mg 20 mg tablets: Robenacoxib 20 mg 40 mg tablets: Robenacoxib 40 mg For the full list of excipients see Pharmaceutical particulars section

Pharmaceutical form

Tablet Round, beige to brown tablets with the imprint "NA" on one side and the following imprint on the other side: 5 mg tablet: AK 10 mg tablet: BE 20 mg tablet: CD 40 mg tablet: BCK

Clinical particulars

Target species

Dog

Indications for use, specifying the target species

For the treatment of pain and inflammation associated with chronic osteoarthritis in dogs.

Contraindications

Do not use in dogs suffering from gastrointestinal ulceration or with hepatic disease. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals (see section below).

Special warnings for each target species

In clinical studies, inadequate response to treatment was seen in 10–15% of the dogs.

Special precautions for use

Special precautions for use in animals The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age. For long term therapy, liver enzymes should be monitored at the start of therapy, e.g. after 2, 4 and 8 weeks. Thereafter it is recommended to continue regular monitoring, e.g. every 3–6 months. Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes. Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these dogs require careful monitoring. Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if the dog previously displayed intolerance to other NSAIDs. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use of the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In small children, accidental ingestion increases the risk for NSAID adverse effects. For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk of premature closure of the ductus arteriosus in the foetus.

Adverse reactions (frequency and seriousness)*

Gastrointestinal adverse events were reported very commonly, but most cases were mild and recovered without treatment. Vomiting and soft faeces were very common, decreased appetite and diarrhoea were common, and blood in the faeces was uncommon. In dogs treated up to 2 weeks no increases in liver enzyme activities were observed. However, with long-term treatment, increases in liver enzyme activities were common. In most cases there were no clinical signs and the liver enzyme activities either stabilised or decreased with continued treatment. Increases in liver enzyme activities associated with clinical signs of anorexia, apathy or vomiting were uncommon. In very rare cases, lethargy may be observed. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).

Use during pregnancy or lactation

Do not use in pregnant or lactating dogs because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.

Interaction with other medicinal products and other forms of interaction

Onsior must not be administered in conjunction with other NSAIDs. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously. Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity. Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.

Amounts to be administered and administration route

For oral use. Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib when administered without food or at least 30 minutes before or after a meal. Onsior tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided or broken.

The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2 mg/kg. Administer once daily at the same time every day according to the table below.

A clinical response is normally seen within a week. Treatment should be discontinued after 10 days if no clinical improvement is apparent. For long-term treatment, once a clinical response has been observed, the dose of Onsior can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic osteoarthritis may vary over time. Regular monitoring should be undertaken by the veterinarian.

Overdose (symptoms, emergency procedures, antidotes), if necessary In healthy young dogs aged 5–6 months, oral robenacoxib administered at high overdoses (4, 6 or 10 mg/kg/day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time. Robenacoxib also had no detrimental effects on cartilages or joints. As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs. There is no specific antidote. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

Withdrawal period Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs. ATCvet code: QM01AH91. Pharmacodynamic properties Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g. in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme and is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.

In an in vitro whole blood assay in dogs, robenacoxib was approximately 140 fold selective for COX-2 (IC50 0.04 μM) as compared to COX-1 (IC50 7.9 μM). Robenacoxib produced marked inhibition of COX-2 activity and had no effect on COX-1 activity in dogs at oral doses ranging from 0.5 to 4 mg/kg. Robenacoxib tablets are therefore COX-1 sparing at recommended doses in dogs. Robenacoxib had analgesic and anti-inflammatory actions in an inflammation model in dogs with single oral doses ranging from 0.5 to 8 mg/kg, with an ID50 of 0.8 mg/kg and a rapid onset of action (0.5 h). In clinical trials robenacoxib tablets reduced the lameness and inflammation of dogs with chronic osteoarthritis.

Pharmacokinetic particulars Absorption After oral administration of robenacoxib flavoured tablets at 1 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1,124 ng/ml and an AUC of 1,249 ng·h/ml. Co-administration of robenacoxib non-flavoured tablets with food produced no delay in Tmax, but slightly lower values for Cmax (832 ng/ml) and AUC (782 ng·h/ml). The systemic bioavailability of robenacoxib tablets in dogs was 62% with food and 84% without food.

Distribution Robenacoxib has a relatively small volume of distribution (Vss 240 ml/kg) and is highly bound to plasma proteins (>99%). Biotransformation Robenacoxib is extensively metabolised by the liver in dogs. Apart from one lactam metabolite, the identity of other metabolites is not known in dogs. Elimination Robenacoxib is cleared rapidly from blood (CL 0.81 L/kg/h) with an elimination t1/2 of 0.7 h after intravenous administration.After oral administration of the tablets, the terminal half-life in blood was 1.2 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood. Robenacoxib is excreted predominantly via the biliary route (around 65%) and the remainder via the kidneys. Repeated oral administration of robenacoxib to dogs at dosages of 2–10 mg/kg for 6 months produced no change in the blood profile, with neither accumulation of robenacoxib nor enzyme induction. Accumulation of metabolites has not been tested. The pharmacokinetics of robenacoxib do not differ between male and female dogs, and are linear over the range 0.5–8 mg/kg.

Pharmaceutical particulars

List of excipients

Yeast powder

Cellulose, microcrystalline

Flavour, artificial beef

Cellulose, powdered

Povidone (K-30)

Crospovidone

Silica, colloidal anhydrous

Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years.

Special precautions for storage

Do not store above 25 °C.

Nature and composition of immediate packaging

Cardboard box containing 1, 2, 4 or 10 Alu/Alu blisters. Each blister contains 7 tablets.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Holder (if different from distributor)

NA

Marketing Authorisation Number

EU/2/08/089/004-019

Date of the first authorisation or date of renewal

Date of first authorisation: 16/12/2008. Date of last renewal: 08/11/2013.

Date of revision of the text

08/11/2013

Any other information

Legal category

Dog 20mg » Priced per Tablet

Onsior 5 mg, 10 mg, 20 mg, 40 mg flavoured tablets for dogs

Qualitative and quantitative composition

Each tablet contains:

Active substance:

5 mg tablets: Robenacoxib 5 mg10 mg tablets: Robenacoxib 10 mg 20 mg tablets: Robenacoxib 20 mg 40 mg tablets: Robenacoxib 40 mg For the full list of excipients see Pharmaceutical particulars section

Pharmaceutical form

Tablet Round, beige to brown tablets with the imprint "NA" on one side and the following imprint on the other side: 5 mg tablet: AK 10 mg tablet: BE 20 mg tablet: CD 40 mg tablet: BCK

Clinical particulars

Target species

Dog

Indications for use, specifying the target species

For the treatment of pain and inflammation associated with chronic osteoarthritis in dogs.

Contraindications

Do not use in dogs suffering from gastrointestinal ulceration or with hepatic disease. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals (see section below).

Special warnings for each target species

In clinical studies, inadequate response to treatment was seen in 10–15% of the dogs.

Special precautions for use

Special precautions for use in animals The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age. For long term therapy, liver enzymes should be monitored at the start of therapy, e.g. after 2, 4 and 8 weeks. Thereafter it is recommended to continue regular monitoring, e.g. every 3–6 months. Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes. Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these dogs require careful monitoring. Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if the dog previously displayed intolerance to other NSAIDs. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use of the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In small children, accidental ingestion increases the risk for NSAID adverse effects. For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk of premature closure of the ductus arteriosus in the foetus.

Adverse reactions (frequency and seriousness)*

Gastrointestinal adverse events were reported very commonly, but most cases were mild and recovered without treatment. Vomiting and soft faeces were very common, decreased appetite and diarrhoea were common, and blood in the faeces was uncommon. In dogs treated up to 2 weeks no increases in liver enzyme activities were observed. However, with long-term treatment, increases in liver enzyme activities were common. In most cases there were no clinical signs and the liver enzyme activities either stabilised or decreased with continued treatment. Increases in liver enzyme activities associated with clinical signs of anorexia, apathy or vomiting were uncommon. In very rare cases, lethargy may be observed. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).

Use during pregnancy or lactation

Do not use in pregnant or lactating dogs because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.

Interaction with other medicinal products and other forms of interaction

Onsior must not be administered in conjunction with other NSAIDs. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously. Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity. Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.

Amounts to be administered and administration route

For oral use. Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib when administered without food or at least 30 minutes before or after a meal. Onsior tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided or broken.

The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2 mg/kg. Administer once daily at the same time every day according to the table below.

A clinical response is normally seen within a week. Treatment should be discontinued after 10 days if no clinical improvement is apparent. For long-term treatment, once a clinical response has been observed, the dose of Onsior can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic osteoarthritis may vary over time. Regular monitoring should be undertaken by the veterinarian.

Overdose (symptoms, emergency procedures, antidotes), if necessary In healthy young dogs aged 5–6 months, oral robenacoxib administered at high overdoses (4, 6 or 10 mg/kg/day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time. Robenacoxib also had no detrimental effects on cartilages or joints. As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs. There is no specific antidote. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

Withdrawal period Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs. ATCvet code: QM01AH91. Pharmacodynamic properties Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g. in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme and is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.

In an in vitro whole blood assay in dogs, robenacoxib was approximately 140 fold selective for COX-2 (IC50 0.04 μM) as compared to COX-1 (IC50 7.9 μM). Robenacoxib produced marked inhibition of COX-2 activity and had no effect on COX-1 activity in dogs at oral doses ranging from 0.5 to 4 mg/kg. Robenacoxib tablets are therefore COX-1 sparing at recommended doses in dogs. Robenacoxib had analgesic and anti-inflammatory actions in an inflammation model in dogs with single oral doses ranging from 0.5 to 8 mg/kg, with an ID50 of 0.8 mg/kg and a rapid onset of action (0.5 h). In clinical trials robenacoxib tablets reduced the lameness and inflammation of dogs with chronic osteoarthritis.

Pharmacokinetic particulars Absorption After oral administration of robenacoxib flavoured tablets at 1 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1,124 ng/ml and an AUC of 1,249 ng·h/ml. Co-administration of robenacoxib non-flavoured tablets with food produced no delay in Tmax, but slightly lower values for Cmax (832 ng/ml) and AUC (782 ng·h/ml). The systemic bioavailability of robenacoxib tablets in dogs was 62% with food and 84% without food.

Distribution Robenacoxib has a relatively small volume of distribution (Vss 240 ml/kg) and is highly bound to plasma proteins (>99%). Biotransformation Robenacoxib is extensively metabolised by the liver in dogs. Apart from one lactam metabolite, the identity of other metabolites is not known in dogs. Elimination Robenacoxib is cleared rapidly from blood (CL 0.81 L/kg/h) with an elimination t1/2 of 0.7 h after intravenous administration.After oral administration of the tablets, the terminal half-life in blood was 1.2 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood. Robenacoxib is excreted predominantly via the biliary route (around 65%) and the remainder via the kidneys. Repeated oral administration of robenacoxib to dogs at dosages of 2–10 mg/kg for 6 months produced no change in the blood profile, with neither accumulation of robenacoxib nor enzyme induction. Accumulation of metabolites has not been tested. The pharmacokinetics of robenacoxib do not differ between male and female dogs, and are linear over the range 0.5–8 mg/kg.

Pharmaceutical particulars

List of excipients

Yeast powder

Cellulose, microcrystalline

Flavour, artificial beef

Cellulose, powdered

Povidone (K-30)

Crospovidone

Silica, colloidal anhydrous

Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years.

Special precautions for storage

Do not store above 25 °C.

Nature and composition of immediate packaging

Cardboard box containing 1, 2, 4 or 10 Alu/Alu blisters. Each blister contains 7 tablets.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Holder (if different from distributor)

NA

Marketing Authorisation Number

EU/2/08/089/004-019

Date of the first authorisation or date of renewal

Date of first authorisation: 16/12/2008. Date of last renewal: 08/11/2013.

Date of revision of the text

08/11/2013

Any other information

Legal category

Dog 40mg » Priced per Tablet

Onsior 5 mg, 10 mg, 20 mg, 40 mg flavoured tablets for dogs

Qualitative and quantitative composition

Each tablet contains:

Active substance:

5 mg tablets: Robenacoxib 5 mg10 mg tablets: Robenacoxib 10 mg 20 mg tablets: Robenacoxib 20 mg 40 mg tablets: Robenacoxib 40 mg For the full list of excipients see Pharmaceutical particulars section

Pharmaceutical form

Tablet Round, beige to brown tablets with the imprint "NA" on one side and the following imprint on the other side: 5 mg tablet: AK 10 mg tablet: BE 20 mg tablet: CD 40 mg tablet: BCK

Clinical particulars

Target species

Dog

Indications for use, specifying the target species

For the treatment of pain and inflammation associated with chronic osteoarthritis in dogs.

Contraindications

Do not use in dogs suffering from gastrointestinal ulceration or with hepatic disease. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals (see section below).

Special warnings for each target species

In clinical studies, inadequate response to treatment was seen in 10–15% of the dogs.

Special precautions for use

Special precautions for use in animals The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age. For long term therapy, liver enzymes should be monitored at the start of therapy, e.g. after 2, 4 and 8 weeks. Thereafter it is recommended to continue regular monitoring, e.g. every 3–6 months. Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes. Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these dogs require careful monitoring. Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if the dog previously displayed intolerance to other NSAIDs. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use of the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In small children, accidental ingestion increases the risk for NSAID adverse effects. For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk of premature closure of the ductus arteriosus in the foetus.

Adverse reactions (frequency and seriousness)*

Gastrointestinal adverse events were reported very commonly, but most cases were mild and recovered without treatment. Vomiting and soft faeces were very common, decreased appetite and diarrhoea were common, and blood in the faeces was uncommon. In dogs treated up to 2 weeks no increases in liver enzyme activities were observed. However, with long-term treatment, increases in liver enzyme activities were common. In most cases there were no clinical signs and the liver enzyme activities either stabilised or decreased with continued treatment. Increases in liver enzyme activities associated with clinical signs of anorexia, apathy or vomiting were uncommon. In very rare cases, lethargy may be observed. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).

Use during pregnancy or lactation

Do not use in pregnant or lactating dogs because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.

Interaction with other medicinal products and other forms of interaction

Onsior must not be administered in conjunction with other NSAIDs. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously. Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity. Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.

Amounts to be administered and administration route

For oral use. Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib when administered without food or at least 30 minutes before or after a meal. Onsior tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided or broken.

The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2 mg/kg. Administer once daily at the same time every day according to the table below.

A clinical response is normally seen within a week. Treatment should be discontinued after 10 days if no clinical improvement is apparent. For long-term treatment, once a clinical response has been observed, the dose of Onsior can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic osteoarthritis may vary over time. Regular monitoring should be undertaken by the veterinarian.

Overdose (symptoms, emergency procedures, antidotes), if necessary In healthy young dogs aged 5–6 months, oral robenacoxib administered at high overdoses (4, 6 or 10 mg/kg/day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time. Robenacoxib also had no detrimental effects on cartilages or joints. As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs. There is no specific antidote. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

Withdrawal period Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs. ATCvet code: QM01AH91. Pharmacodynamic properties Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g. in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme and is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.

In an in vitro whole blood assay in dogs, robenacoxib was approximately 140 fold selective for COX-2 (IC50 0.04 μM) as compared to COX-1 (IC50 7.9 μM). Robenacoxib produced marked inhibition of COX-2 activity and had no effect on COX-1 activity in dogs at oral doses ranging from 0.5 to 4 mg/kg. Robenacoxib tablets are therefore COX-1 sparing at recommended doses in dogs. Robenacoxib had analgesic and anti-inflammatory actions in an inflammation model in dogs with single oral doses ranging from 0.5 to 8 mg/kg, with an ID50 of 0.8 mg/kg and a rapid onset of action (0.5 h). In clinical trials robenacoxib tablets reduced the lameness and inflammation of dogs with chronic osteoarthritis.

Pharmacokinetic particulars Absorption After oral administration of robenacoxib flavoured tablets at 1 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1,124 ng/ml and an AUC of 1,249 ng·h/ml. Co-administration of robenacoxib non-flavoured tablets with food produced no delay in Tmax, but slightly lower values for Cmax (832 ng/ml) and AUC (782 ng·h/ml). The systemic bioavailability of robenacoxib tablets in dogs was 62% with food and 84% without food.

Distribution Robenacoxib has a relatively small volume of distribution (Vss 240 ml/kg) and is highly bound to plasma proteins (>99%). Biotransformation Robenacoxib is extensively metabolised by the liver in dogs. Apart from one lactam metabolite, the identity of other metabolites is not known in dogs. Elimination Robenacoxib is cleared rapidly from blood (CL 0.81 L/kg/h) with an elimination t1/2 of 0.7 h after intravenous administration.After oral administration of the tablets, the terminal half-life in blood was 1.2 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood. Robenacoxib is excreted predominantly via the biliary route (around 65%) and the remainder via the kidneys. Repeated oral administration of robenacoxib to dogs at dosages of 2–10 mg/kg for 6 months produced no change in the blood profile, with neither accumulation of robenacoxib nor enzyme induction. Accumulation of metabolites has not been tested. The pharmacokinetics of robenacoxib do not differ between male and female dogs, and are linear over the range 0.5–8 mg/kg.

Pharmaceutical particulars

List of excipients

Yeast powder

Cellulose, microcrystalline

Flavour, artificial beef

Cellulose, powdered

Povidone (K-30)

Crospovidone

Silica, colloidal anhydrous

Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years.

Special precautions for storage

Do not store above 25 °C.

Nature and composition of immediate packaging

Cardboard box containing 1, 2, 4 or 10 Alu/Alu blisters. Each blister contains 7 tablets.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Holder (if different from distributor)

NA

Marketing Authorisation Number

EU/2/08/089/004-019

Date of the first authorisation or date of renewal

Date of first authorisation: 16/12/2008. Date of last renewal: 08/11/2013.

Date of revision of the text

08/11/2013

Any other information

Legal category

Dog 5mg » Priced per Tablet

Onsior 5 mg, 10 mg, 20 mg, 40 mg flavoured tablets for dogs

Qualitative and quantitative composition

Each tablet contains:

Active substance:

5 mg tablets: Robenacoxib 5 mg10 mg tablets: Robenacoxib 10 mg 20 mg tablets: Robenacoxib 20 mg 40 mg tablets: Robenacoxib 40 mg For the full list of excipients see Pharmaceutical particulars section

Pharmaceutical form

Tablet Round, beige to brown tablets with the imprint "NA" on one side and the following imprint on the other side: 5 mg tablet: AK 10 mg tablet: BE 20 mg tablet: CD 40 mg tablet: BCK

Clinical particulars

Target species

Dog

Indications for use, specifying the target species

For the treatment of pain and inflammation associated with chronic osteoarthritis in dogs.

Contraindications

Do not use in dogs suffering from gastrointestinal ulceration or with hepatic disease. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals (see section below).

Special warnings for each target species

In clinical studies, inadequate response to treatment was seen in 10–15% of the dogs.

Special precautions for use

Special precautions for use in animals The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age. For long term therapy, liver enzymes should be monitored at the start of therapy, e.g. after 2, 4 and 8 weeks. Thereafter it is recommended to continue regular monitoring, e.g. every 3–6 months. Therapy should be discontinued if liver enzyme activities increase markedly or the dog shows clinical signs such as anorexia, apathy or vomiting in combination with elevated liver enzymes. Use in dogs with impaired cardiac or renal function or dogs that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these dogs require careful monitoring. Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if the dog previously displayed intolerance to other NSAIDs. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use of the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. In small children, accidental ingestion increases the risk for NSAID adverse effects. For pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk of premature closure of the ductus arteriosus in the foetus.

Adverse reactions (frequency and seriousness)*

Gastrointestinal adverse events were reported very commonly, but most cases were mild and recovered without treatment. Vomiting and soft faeces were very common, decreased appetite and diarrhoea were common, and blood in the faeces was uncommon. In dogs treated up to 2 weeks no increases in liver enzyme activities were observed. However, with long-term treatment, increases in liver enzyme activities were common. In most cases there were no clinical signs and the liver enzyme activities either stabilised or decreased with continued treatment. Increases in liver enzyme activities associated with clinical signs of anorexia, apathy or vomiting were uncommon. In very rare cases, lethargy may be observed. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).

Use during pregnancy or lactation

Do not use in pregnant or lactating dogs because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.

Interaction with other medicinal products and other forms of interaction

Onsior must not be administered in conjunction with other NSAIDs. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously. Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity. Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.

Amounts to be administered and administration route

For oral use. Do not administer with food since clinical trials demonstrated better efficacy of robenacoxib when administered without food or at least 30 minutes before or after a meal. Onsior tablets are flavoured and are taken voluntarily by most dogs. The tablets should not be divided or broken.

The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2 mg/kg. Administer once daily at the same time every day according to the table below.

A clinical response is normally seen within a week. Treatment should be discontinued after 10 days if no clinical improvement is apparent. For long-term treatment, once a clinical response has been observed, the dose of Onsior can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic osteoarthritis may vary over time. Regular monitoring should be undertaken by the veterinarian.

Overdose (symptoms, emergency procedures, antidotes), if necessary In healthy young dogs aged 5–6 months, oral robenacoxib administered at high overdoses (4, 6 or 10 mg/kg/day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time. Robenacoxib also had no detrimental effects on cartilages or joints. As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs. There is no specific antidote. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

Withdrawal period Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs. ATCvet code: QM01AH91. Pharmacodynamic properties Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g. in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme and is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.

In an in vitro whole blood assay in dogs, robenacoxib was approximately 140 fold selective for COX-2 (IC50 0.04 μM) as compared to COX-1 (IC50 7.9 μM). Robenacoxib produced marked inhibition of COX-2 activity and had no effect on COX-1 activity in dogs at oral doses ranging from 0.5 to 4 mg/kg. Robenacoxib tablets are therefore COX-1 sparing at recommended doses in dogs. Robenacoxib had analgesic and anti-inflammatory actions in an inflammation model in dogs with single oral doses ranging from 0.5 to 8 mg/kg, with an ID50 of 0.8 mg/kg and a rapid onset of action (0.5 h). In clinical trials robenacoxib tablets reduced the lameness and inflammation of dogs with chronic osteoarthritis.

Pharmacokinetic particulars Absorption After oral administration of robenacoxib flavoured tablets at 1 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1,124 ng/ml and an AUC of 1,249 ng·h/ml. Co-administration of robenacoxib non-flavoured tablets with food produced no delay in Tmax, but slightly lower values for Cmax (832 ng/ml) and AUC (782 ng·h/ml). The systemic bioavailability of robenacoxib tablets in dogs was 62% with food and 84% without food.

Distribution Robenacoxib has a relatively small volume of distribution (Vss 240 ml/kg) and is highly bound to plasma proteins (>99%). Biotransformation Robenacoxib is extensively metabolised by the liver in dogs. Apart from one lactam metabolite, the identity of other metabolites is not known in dogs. Elimination Robenacoxib is cleared rapidly from blood (CL 0.81 L/kg/h) with an elimination t1/2 of 0.7 h after intravenous administration.After oral administration of the tablets, the terminal half-life in blood was 1.2 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood. Robenacoxib is excreted predominantly via the biliary route (around 65%) and the remainder via the kidneys. Repeated oral administration of robenacoxib to dogs at dosages of 2–10 mg/kg for 6 months produced no change in the blood profile, with neither accumulation of robenacoxib nor enzyme induction. Accumulation of metabolites has not been tested. The pharmacokinetics of robenacoxib do not differ between male and female dogs, and are linear over the range 0.5–8 mg/kg.

Pharmaceutical particulars

List of excipients

Yeast powder

Cellulose, microcrystalline

Flavour, artificial beef

Cellulose, powdered

Povidone (K-30)

Crospovidone

Silica, colloidal anhydrous

Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years.

Special precautions for storage

Do not store above 25 °C.

Nature and composition of immediate packaging

Cardboard box containing 1, 2, 4 or 10 Alu/Alu blisters. Each blister contains 7 tablets.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Holder (if different from distributor)

NA

Marketing Authorisation Number

EU/2/08/089/004-019

Date of the first authorisation or date of renewal

Date of first authorisation: 16/12/2008. Date of last renewal: 08/11/2013.

Date of revision of the text

08/11/2013

Any other information

Legal category

Solution for Injection » 20mg/ml

Onsior 20 mg / ml solution for injection for cats and dogs

Qualitative and quantitative composition

Each ml contains:

Active substance: Robenacoxib 20 mg

Excipient: Sodium metabisulphite (E 223)

For the full list of excipients see Pharmaceutical particulars section

Pharmaceutical form

Solution for injection.

Clear, colourless to slightly coloured (pink) liquid.

Clinical particulars

Target species Cats and dogs.

Indications for use, specifying the target species

For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs. For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in cats.

Contraindications Do not use in animals suffering from gastrointestinal ulceration. Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs). Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals.

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

The safety of the veterinary medicinal product has not been established in cats less than 4 months of age and in dogs less than 2 months of age, or in cats or dogs less than 2.5 kg body weight.

Use in animals with impaired cardiac, renal or hepatic function or those are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these animals require careful monitoring and fluid therapy. Use this veterinary medicinal product under strict veterinary monitoring in cases at risk of gastrointestinal ulceration, or if the animal previously displayed intolerance to other NSAIDs.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands and exposed skin immediately after use of the product.

In case of accidental ingestion or self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus.

Adverse reactions (frequency and seriousness)

Cats: Gastrointestinal adverse events (vomiting, soft faeces or diarrhoea) were commonly reported, but most cases were mild and recovered without treatment. Diarrhoea or vomiting with blood was uncommon. Pain at injection site was commonly reported.

Dogs: Gastrointestinal adverse events (such as vomiting) were commonly reported but most cases were mild and recovered without treatment. Diarrhoea, soft and dark faeces or reduced appetite were uncommon. Slight pain at injection site was commonly reported. Moderate or severe pain at injection site was uncommon.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

Use during pregnancy, lactation or lay Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding.

Interaction with other medicinal products and other forms of interaction

Onsior must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.

Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring. In healthy cats treated with or without the diuretic furosemide, concomitant administration of Onsior with the ACE inhibitor benazepril for 7 days was not associated with any negative effects on plasma aldosterone concentrations, plasma renin activity or glomerular filtration rate. No safety data in the target population and no efficacy data in general exist for the combined treatment of robenacoxib and benazepril.

As anaesthetics may affect renal perfusion, the use of parenteral fluid therapy during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.

Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity.

Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.

Amounts to be administered and administration route

Subcutaneous use. Administer subcutaneously to cats or dogs approximately 30 minutes before the start of surgery, for example around the time of induction of general anaesthesia, at a dose of 1 ml per 10 kg of body weight (2 mg/kg). After surgery in cats, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days.

The interchangeable use of Onsior tablets and Onsior solution for injection has been tested in a target animal safety study and was shown to be well tolerated by cats.

For cats, Onsior solution for injection or tablets may be used interchangeably in accordance with the indications and directions of use approved for each pharmaceutical form. Treatment should not exceed one dose (either tablet or injection) per day. Please note that the recommended doses for the two formulations are different.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In healthy young dogs aged 6 months, once daily subcutaneous administration of robenacoxib at doses of 2 (recommended therapeutic dose; RTD), 6 (3 times RTD), and 20 mg/kg (10 times RTD) for 9 administrations over a 5 week period (3 cycles of 3 consecutive once daily injections) did not produce any signs of toxicity, including gastrointestinal, kidney or liver toxicity and had no effect on bleeding time. Reversible inflammation at the injection site was noted in all groups (including controls) and was more severe in the 6 and 20 mg/kg dose groups.

In healthy young cats aged 10 months, once daily subcutaneous administration of robenacoxib at doses of 4 mg/kg (twice RTD) for 2 consecutive days and 10 mg/kg (5 times RTD) for 3 consecutive days did not produce any signs of toxicity, including signs of gastrointestinal, kidney or liver toxicity and had no effect on bleeding time. Reversible, minimal injection site reactions were noted in both dose groups.

The interchangeable use of Onsior tablets and Onsior solution for injection in 4-months old cats at overdoses of up to 3 times the maximum recommended dose (2.4 mg, 4.8 mg, 7.2 mg robenacoxib/kg orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg subcutaneously) resulted in a dose-dependent increase of sporadic oedema at the injection site and minimal to mild subacute/chronic inflammation of the subcutaneous tissue. A dose-dependent increase in the QT interval, a decreased heart rate and corresponding increased respiratory rate were observed in laboratory studies. No relevant effects on body weight, bleeding time or evidence of any gastrointestinal, kidney or liver toxicity were observed.

In overdose studies conducted in cats, there was a dose-dependent increase in the QT interval. The biological relevance of increased QT intervals outside of normal variations observed following overdose of robenacoxib is unknown. No changes in the QT interval were observed after single intravenous administration of 2 or 4 mg /kg robenacoxib to anaesthetised healthy cats.

As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised animals. There is no specific antidote. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.

Withdrawal period

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs.

ATCvet code: QM01AH91.

Pharmacodynamic properties

Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g. in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme and is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.

In cats, using an in vitro whole blood assay, robenacoxib was approximately 500 fold selective for COX-2 (IC50 0.058 μM) as compared to COX-1 (IC50 28.9 μM). In vivo, robenacoxib solution for injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity. At the recommended dosage (2 mg/kg), analgesic, anti-inflammatory and anti-pyretic effects were demonstrated in an inflammation model, and in clinical trials, robenacoxib reduced pain and inflammation in cats undergoing orthopaedic or soft tissue surgery.

In dogs, robenacoxib was in vitro approximately 140 fold selective for COX-2 (IC50 0.04 μM) as compared to COX-1 (IC50 7.9 μM). In vivo, robenacoxib solution for injection produced marked inhibition of COX-2 activity and had no effect on COX-1 activity. At dosages ranging from 0.25 to 4 mg/kg, robenacoxib had analgesic, anti-inflammatory and anti-pyretic effects in an inflammation model with a rapid onset of action (1 h). In clinical trials at the recommended dose (2 mg/kg), robenacoxib reduced pain and inflammation in dogs undergoing orthopaedic or soft tissue surgery.

Pharmacokinetic particulars

Absorption

Peak blood concentrations of robenacoxib are attained rapidly after subcutaneous injection in cats and dogs. After a dosage of 2 mg/kg a Tmax of 1 h (cats and dogs), a Cmax of 1,464 ng/ml (cats) and 615 ng/ml (dogs), and an AUC of 3,128 ng·h/ml (cats) and 2,180 ng·h/ml (dogs) is obtained. After a subcutaneous administration of 1 mg/kg the systemic bioavailability is 69% in cats and 88% in dogs.

Distribution

Robenacoxib has a relatively small volume of distribution (Vss of 190 ml/kg in cats and 240 ml/kg in dogs) and is highly bound to plasma proteins (>99%).

Biotransformation

Robenacoxib is extensively metabolised by the liver in cats and dogs. Apart from one lactam metabolite, the identity of other metabolites is not known in cats or dogs.

Elimination

After intravenous administration robenacoxib was rapidly cleared from blood (CL of 0.44 L/kg/h in cats and 0.81 L/kg/h in dogs) with an elimination t1/2 of 1.1 h in cats and 0.8 h in dogs.After subcutaneous administration, the terminal half-life from blood was 1.1 h in cats and 1.2 h in dogs. Robenacoxib persists longer and in higher concentrations at sites of inflammation than in blood. Robenacoxib is excreted predominantly via the biliary route in cats (around 70%) and dogs (around 65%) and the remainder via the kidneys. Repeated subcutaneous administration at dosages of 2–20 mg/kg produced no change in the blood profile, with neither bioaccumulation of robenacoxib nor enzyme induction. Bioaccumulation of metabolites has not been tested. The pharmacokinetics of robenacoxib injection do not differ between male and female cats and dogs, and are linear over the range of 0.25–4 mg/kg in dogs.

Pharmaceutical particulars

List of excipients Macrogol 400 Ethanol, anhydrous Poloxamer 188 Citric acid monohydrate Sodium metabisulphite (E 223) Sodium hydroxide Water for injections

Incompatibilities In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first broaching of the vial: 28 days. Special precautions for storage Store in a refrigerator (2 °C – 8 °C).Refrigeration is not required during the 4-week in-use period after first broaching of the vial. Avoid introduction of contamination. Keep the vial in the outer carton.

Nature and composition of immediate packaging Multi-dose amber glass vial containing 20 ml solution for injection, closed with a rubber stopper and sealed with an aluminium cap. One vial packed in a cardboard box.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing Authorisation Holder (if different from distributor)

NA

Marketing Authorisation Number

EU/2/08/089/020

Date of the first authorisation or date of renewal

Date of first authorisation: 16/12/2008. Date of last renewal: 08/11/2013.

Date of revision of the text

August 2018

Any other information

Legal category

Delivery Information

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Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

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For UK delivery, we charge the following:

Order Total Weight Delivery
£0-£28.99 Under 2kg £2.99
2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

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Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

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*For full details on returns, see our terms and conditions page.

Reviews (47)

Q & A

Below are some recent questions we've received regarding Onsior for Dogs & Cats, including answers from our team.

13 July 2016 at 2:22pm

Onsior or Previcox

Cherry Welsh

  • VioVet customer since 2015
  • From: Argyll and Bute, United Kingdom

I would be grateful if you could tell me if there is any significant difference between these 2 drugs regarding their safety and effectiveness in treating osteoarthritis.

My dog had Onsior for a few weeks and it didn't seem to make much difference.

With thanks

  • Non-Executive Director

These are both effective normally at reducing the discomfort from osteoarthritis. I am not aware of any scientific investigations conducted to try and compare them in this way, but they are both generally regarded as about equally safe and effective based on anecdotal evidence. Some dogs might happen to respond better to one drug than another, but I do not think that is particularly likely. I would have to question if the symptoms you are noticing are genuinely caused by the osteoarthritis which has been identified. Obviously I cannot tell and indeed it might be very difficult to be sure, but I would say that sometimes osteoarthritis can exist without causing obvious trouble for the dog. Another, unidentified condition could be causing trouble now, rather than the osteoarthritis. My first suggestion would be to re-evaluate the diagnosis, which obviously means going back to your vet. If nothing else is identified, then perhaps just try a different drug as well as doing all you can in other ways to help. Joint supplements such as Yumove or Joint Force are widely believed to be able to help. It is also helpful to encourage regular, gentle exercise (but never excited, strenuous or prolonged). Weight loss through food reduction is for some dogs the most beneficial thing you can do, but that depends on the current bodyweight and other factors. All else being equal though, you aim for a slim dog. It is always possible through simply giving less food, but that is very difficult for many people in practice.

19 December 2015 at 9:55am

Yumove

Neil

Can this be given at the same time as yumove?

  • Non-Executive Director

It is very common to use a prescription, anti-inflammatory drug such as Onsior along with a non-prescription, joint supplement such as Yumove. Many vets do recommend this and it is safe. Other measures can involve restricting food levels a bit to help keep body weight down as well as encouraging regular but gentle exercise.

21 April 2015 at 9:02pm

Onsior overdose?

Gilly Peters

Hector is on constant Onsior, 1 tablet per day, but today we both inadvertently dosed him, so he has taken 2. Could this be dangerous? He seems hyper and a bit "whiney" (He is a 30kg Lab/lurcher).

  • Non-Executive Director

This is unlikely to cause trouble, but it certainly could. If your dog shows any vomiting or diarrhoea it is important not to give any more tablets and go straight to your vet. If he seems fine then all should be well. I would be tempted to miss out the next dose though.

23 February 2015 at 2:20pm

Extra Tablets

Deanna

Hello there
My dog has just been diagnosed with Elbow Dysplasia and has been given these Onsior tablets (40mg) to take.
We was wondering if we can also give him some herbal tablets too, as we gave him them before and seemed to help him, however we do not want any weird side effects.
Thank you for your help
Deanna Miller

  • Non-Executive Director

Most herbal tablets appear to be safe and can be given alongside Onsior, but they have not all been tested and there is no scientific confirmation of that initial comment. Personally I would be happy for you to give any of the main brand herbal products at the recommended amount alongside Onsior. As long as your dog is otherwise well, it is very unlikely that there would be any sort of adverse reaction.The glucosamine/chondroitin based supplements, such as Joint Force, are regarded as particularly suitable to add to the treatment.

6 May 2014 at 11:00pm

Hair loss

Lexie

My dog has been taking on onsior and is doing her leg good, can you please tell me if it has any side effects as she is losing her coat, it started with a lilltle bald patch on her back but now it's coming out on her chest
Please help
Thank you

  • Non-Executive Director

Onsior can occasionally have side effects, but hair loss is very unlikely to be due to the Onsior. It is much more likely to be a coincidence that the hair loss is occurring at the same time. I would make sure that your flea control measures are adequate, even if you see no fleas, and take your cat to the vet to be checked out for any other causes. (A flea allergy would be a very common cause for hair loss on cats, and can happen with very few fleas which are difficult to see.)