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Inflacam For Horses

Inflacam For Horses
Granules » 330mg Sachet » Pack of 100
Oral Suspension » 15mg/ml » 100ml Bottle

  • Granules » 330mg Sachet » Pack of 100 £205.99
  • Granules » 330mg Sachet » Priced per Sachet £2.09
  • Oral Suspension » 15mg/ml » 100ml Bottle £22.99
  • Oral Suspension » 15mg/ml » 250ml Bottle £46.49
  • Oral Suspension » 20mg/ml » 100ml Bottle £98.50

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Description

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses. Granules are apple flavoured for palatability.

Inflacam 15mg/mL oral suspension for horses

Species: Horses and other equidae Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Horse NSAIDs Active ingredient: Meloxicam Product:Inflacam 15mg/mL oral suspension for horses Product index: Inflacam 15mg/mL oral suspension for horses Withdrawal notes: Meat and offal: 3 days. Not authorised for use in lactating animals producing milk for human consumption.

Qualitative and quantitative composition

One ml contains: Active substance: Meloxicam 15 mg Excipient: Sodium benzoate 5 mg. For the full list of excipients, see section 6.1.

Pharmaceutical form

Oral suspension. White to off-white viscous oral suspension.

Clinical particulars

Target species

Horses

Indications for use

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

Contra-indications

Do not use in pregnant or lactating mares. Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in horses less than 6 weeks of age.

Special warnings for each target species

None

Special precautions for use

Special precautions for use in animals Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported. In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically. If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in this species is not recommended during pregnancy and lactation.

Interactions

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

Amounts to be administered and administration route

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding. The suspension should be given using the Inflacam measuring syringe provided in the package. The syringe fits onto the bottle and has a 2 ml scale. Shake well before use. After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry. Avoid introduction of contamination during use.

Overdose

In the case of overdose symptomatic treatment should be initiated.

Withdrawal periods

Meat and offal: 3 days. Not authorised for use in lactating animals producing milk for human consumption.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and Anti-rheumatic products, non-steroids (oxicams). ATCvet code: QM01AC06.

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.

Pharmacokinetic properties

Absorption When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%. Maximal plasma concentrations are obtained after approximately 2–3 hours. The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily. Distribution Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg. Metabolism The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs, although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy- metabolites and the oxalyl- metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive. Elimination Meloxicam is eliminated with a terminal half-life of 7.7 hours.

Pharmaceutical particulars

Excipients

Saccharin sodium Carmellose sodium Silica, colloidal anhydrous Citric acid monohydrate Sorbitol, liquid (non-crystallising) Disodium phosphate dodecahydrate Sodium benzoate Honey aroma Purified water

Major incompatibilities

None known

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening of the immediate packaging: 3 months.

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Immediate packaging

HDPE bottle containing 100 or 250 ml with a tamper proof child resistant closure and a polypropylene measuring syringe. Not all pack sizes may be marketed.

Disposal

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)

Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland.

Marketing Authorisation Number

EU/2/11/134/009 100 ml EU/2/11/134/010 250 ml

Significant changes

Date of the first authorisation or date of renewal

09/12/2011

Date of revision of the text

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).

Any other information

Nil

Legal category

Legal category: POM-V

GTIN

GTIN description:Inflacam 15mg/ml oral suspension for Horses 100ml GTIN:5099299026445 GTIN description:Inflacam 15mg/ml oral suspension for Horses 250ml GTIN:5099299027329

Inflacam 330 mg, granules for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION


One sachet contains:
Active substance:
Meloxicam 330 mg.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Granules in sachet.
Pale yellow granules.

4. CLINICAL PARTICULARS

4.1 Target species

Horses.

4.2 Indications for use, specifying the target species

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses weighing between 500 and 600 kg.

4.3 Contraindications

Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.

4.4 Special warnings for each target species.

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
In order to minimise risk of intolerance, the product should be mixed into muesli feed.
This product is only for use in horses weighing between 500 and 600 kg.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported. In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions 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).

4.7 Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in horses is not recommended during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticoids, other NSAIDs or with anti-coagulant agents.

4.9 Amounts to be administered and administration route

In-feed use.
To be administered mixed with food at a dose of 0.6 mg/kg body weight, once daily, up to 14 days.
The product should be added to 250 g of muesli feed, prior to feeding.
Each sachet contains one dose for a horse weighing between 500 and 600 kg and the dose must not be divided into smaller doses.
Avoid introduction of contamination during use.

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

In the case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%. Maximal plasma concentrations are obtained after approximately 2–3 hours. The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.


Distribution
Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.


Metabolism
The metabolism is qualitatively similar in rats, humans, cattle and pigs (including mini-pigs), although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxyand 5-carboxy- metabolites and the oxalyl- metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a terminal half-life of 7.7 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Glucose monohydrate
Povidone
Apple flavour (containing butylated hydroxyanisole (E320))
Crospovidone

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

6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after incorporation into muesli feed: use immediately.

6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging
Paper foil sachets (paper/PE/alu/PE) containing 1.5 g granules per sachet in a cardboard box with 100 sachets.
Not all pack sizes may be marketed.

6.6 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.

7. MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Limited
Loughrea,
Co. Galway,
IRELAND.

8. MARKETING AUTHORISATION NUMBERS

EU/2/11/134/021

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/12/2011.

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (http://www.ema.europa.eu).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable

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Medication Datasheets

Oral Suspension » 15mg/ml » 100ml Bottle

Inflacam 15mg/mL oral suspension for horses

Qualitative and quantitative composition

One ml contains:

Active substance:

Meloxicam 15 mg

Excipient:

Sodium benzoate 5 mg.

For the full list of excipients, see section 6.1.

Pharmaceutical form

Oral suspension.

White to off-white viscous oral suspension.

Clinical particulars

Target species

Horses

Indications for use

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

Contra-indications

Do not use in pregnant or lactating mares.

Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

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

Do not use in horses less than 6 weeks of age.

Special warnings for each target species

None

Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

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

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

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

Adverse reactions

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.

In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.

In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in this species is not recommended during pregnancy and lactation.

Interactions

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

Amounts to be administered and administration route

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.

The suspension should be given using the Inflacam measuring syringe provided in the package. The syringe fits onto the bottle and has a 2 ml scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

Avoid introduction of contamination during use.

Overdose

In the case of overdose symptomatic treatment should be initiated.

Withdrawal periods

Meat and offal: 3 days.

Not authorised for use in lactating animals producing milk for human consumption.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and Anti-rheumatic products, non-steroids (oxicams).

ATCvet code: QM01AC06.

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.

Pharmacokinetic properties

Absorption

When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%. Maximal plasma concentrations are obtained after approximately 2–3 hours. The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution

Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism

The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs, although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy- metabolites and the oxalyl- metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a terminal half-life of 7.7 hours.

Pharmaceutical particulars

Excipients

Saccharin sodium

Carmellose sodium

Silica, colloidal anhydrous

Citric acid monohydrate

Sorbitol, liquid (non-crystallising)

Disodium phosphate dodecahydrate

Sodium benzoate

Honey aroma

Purified water

Major incompatibilities

None known

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening of the immediate packaging: 3 months.

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Immediate packaging

HDPE bottle containing 100 or 250 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.

Not all pack sizes may be marketed.

Disposal

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)

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

Ireland.

Marketing Authorisation Number

EU/2/11/134/009 100 ml

EU/2/11/134/010 250 ml

Date of the first authorisation or date of renewal

09/12/2011

Date of revision of the text

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).

Any other information

Nil

Legal category

Oral Suspension » 20mg/ml » 100ml Bottle

Inflacam 20mg/ml solution for injection for cattle, pigs and horses

Qualitative and quantitative composition

One ml contains as active substance: Meloxicam 20mg

Pharmaceutical form

Clear yellow solution for injection

Clinical particulars

Target species

Cattle, pigs and horses

Indications for use

Cattle:

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

For the relief of post-operative pain following dehorning in calves.

Pigs:

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

Horses:

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

For the relief of pain associated with equine colic.

Contra-indications

Do not use in horses less than 6 weeks of age.

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

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

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

Special warnings for each target species

Treatment of calves with Inflacam 20 minutes before dehorning reduces post-operative pain. Inflacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

Special precautions for use

Special precautions for use in animals

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.

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

Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions

In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

Use during pregnancy, lactation or lay

Cattle and pigs:

Can be used during pregnancy and lactation.

Horses:

Do not use in pregnant or lactating mares.

Interactions

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

Amounts to be administered and administration route

Cattle:

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.

Horses:

Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo – skeletal disorders, Inflacam 15 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

Overdose

In the case of overdose, symptomatic treatment should be initiated.

Withdrawal periods

Cattle:

Meat and offal: 15 days.

Milk: 5 days.

Pigs:

Meat and offal: 5 days.

Horses:

Meat and offal: 5 days.

Not authorised for use in horses producing milk for human consumption.

Pharmacological particulars

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.

Pharmacokinetic properties

Absorption

After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.

After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.

Distribution

More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism

Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. The metabolism in horses has not been investigated.

Elimination

Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.

In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

Pharmaceutical particulars

Excipients

- Ethanol (96%)

- Poloxamer 188

- Macrogol 400

- Glycine

- Sodium hydroxide

- Hydrochloric acid, concentrated

- Meglumine

- Water for injections

Major incompatibilities

None known.

Shelf life

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

Shelf life after first opening the immediate packaging: 28 days.

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Immediate packaging

Cardboard box with 1 colourless glass injection vial containing 20 ml, 50 ml, 100 ml or 250 ml.

Each vial is closed with a rubber stopper and sealed with an aluminium cap.

Not all pack sizes may be marketed.

Disposal

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)

Marketing Authorisation Number

EU/2/11/134/005 20 ml

EU/2/11/134/006 50 ml

EU/2/11/134/007 100 ml

EU/2/11/134/008 250 ml

Date of the first authorisation or date of renewal

09/12/2011

Date of revision of the text

Any other information

Nil

Legal category

Oral Suspension » 15mg/ml » 250ml Bottle

Inflacam 15mg/mL oral suspension for horses

Qualitative and quantitative composition

One ml contains:

Active substance:

Meloxicam 15 mg

Excipient:

Sodium benzoate 5 mg.

For the full list of excipients, see section 6.1.

Pharmaceutical form

Oral suspension.

White to off-white viscous oral suspension.

Clinical particulars

Target species

Horses

Indications for use

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

Contra-indications

Do not use in pregnant or lactating mares.

Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

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

Do not use in horses less than 6 weeks of age.

Special warnings for each target species

None

Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

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

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

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

Adverse reactions

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.

In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.

In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore the use in this species is not recommended during pregnancy and lactation.

Interactions

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

Amounts to be administered and administration route

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.

The suspension should be given using the Inflacam measuring syringe provided in the package. The syringe fits onto the bottle and has a 2 ml scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

Avoid introduction of contamination during use.

Overdose

In the case of overdose symptomatic treatment should be initiated.

Withdrawal periods

Meat and offal: 3 days.

Not authorised for use in lactating animals producing milk for human consumption.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and Anti-rheumatic products, non-steroids (oxicams).

ATCvet code: QM01AC06.

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.

Pharmacokinetic properties

Absorption

When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%. Maximal plasma concentrations are obtained after approximately 2–3 hours. The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution

Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism

The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs, although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy- metabolites and the oxalyl- metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a terminal half-life of 7.7 hours.

Pharmaceutical particulars

Excipients

Saccharin sodium

Carmellose sodium

Silica, colloidal anhydrous

Citric acid monohydrate

Sorbitol, liquid (non-crystallising)

Disodium phosphate dodecahydrate

Sodium benzoate

Honey aroma

Purified water

Major incompatibilities

None known

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening of the immediate packaging: 3 months.

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Immediate packaging

HDPE bottle containing 100 or 250 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.

Not all pack sizes may be marketed.

Disposal

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)

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

Ireland.

Marketing Authorisation Number

EU/2/11/134/009 100 ml

EU/2/11/134/010 250 ml

Date of the first authorisation or date of renewal

09/12/2011

Date of revision of the text

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).

Any other information

Nil

Legal category

Delivery Information

How quickly do you deliver?

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.

What do you charge for delivery?

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

Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.

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.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

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

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