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Inflacam For Horses

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

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  • Granules » 330mg Sachet » Pack of 100 £227.50
  • Granules » 330mg Sachet » Priced per Sachet £2.29
  • Oral Suspension » 15mg/ml » 100ml Bottle £25.00
  • Oral Suspension » 15mg/ml » 250ml Bottle £53.50
  • Oral Suspension » 20mg/ml » 100ml Bottle £109.49

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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

Granules » 330mg Sachet » Priced per Sachet

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2015 . Reproduction is authorised provided the source is acknowledged. 8 October 2015 EMA/674069/2015 Veterinary Medicines Division Committee for Medicinal Products for Veterinary Use (CVMP) CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) International non -proprietary name: meloxicam Assessment report as adopted by the CVMP with all information of a commercially confidential nature deleted. CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 2 / 14 Product profile Invented name: Inflacam Active Substances: Meloxicam Target Species: Horses Pharmaceutical Form: Granules in sachet Strength: 330 mg Therapeutic Indication: Alleviation of inflammation and relief of pain in both acute and chronic musculo -skeletal disorders in horses weighing between 500 a nd 600 kg ATCvet code: QM01AC06 Pharmacotherapeutic group: Anti -inflammatory an d anti -rheumatic products, non -steroids (oxicams) Applicant: Chanelle Pharmaceuticals Manufacturing Ltd IDA Industrial Estate Dublin Road Loughrea Co Galway IRELAND CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 3 / 14 Introduction On 23 April 2015, t he applicant Chanelle Pharmaceuticals Manufacturing Lt d submitted an application for an extension to the Community marketing authorisation for Inflacam to the European Medicines Agency (the Agency) falling within Article 19 of Commission Regulation (EC) No. 1234/2008, and Annex I points 2(c) and 2 (d) thereof. Inflacam contains meloxicam and was first authorised for use in the European Union on 9 December 2011 under Article 13(1) of Directive 2001/82/EC, a generic application.
The product is currently available in different pharmaceutical forms , including oral suspension for dogs (1.5 mg/ml) and horses (15 mg/ml), chewable tablets for dogs (1 mg and 2.5 mg), solution for injection for dogs, cats, cattle and pigs (5 mg/ml), and solution for injection for cattle, pigs and horses (20 mg/ml) .
This extension applic ation is to add a new strength of meloxicam (330 mg) and a new pharmaceutical form (oral granules) for horses. T he route of administration is in -feed use. The reference product is Metacam 15 mg/ml oral suspension for horses; no corresponding Metacam 330 mg granules is authorised. The applicant applied for the following indication: a lleviation of inflammation and relief of pain in both acute and chronic musculo -skeletal disorders in horses weighing between 500 and 600 kg. The rapporteur for this application wa s Sylvie Louet and the co -rapporteur wa s E. -M. Vestergaard. On 8 October 2015, t he CVMP adopted an opinion and CVMP assessment report. On 2 December 2015, the European Commission adopted a Commission Decision for granting an extension to the marketing authorisation for Inflacam. Scientific advice Not applicable. MUMS/ limited market s tatus Horses are a minor species but the applicant did not request MUMS /limited market classification for this application by the CVMP . Part 1 - Administrative particulars Detailed description of the pharmacovigilance system A detailed description of the phar macovigilance system was provided which fulfils the current legal requirements of Directive 2001/82/EC. Based on the information provided the applicant has the services of a qualified person responsible for pharmacovigilance and the necessary means for the notification of any adverse reaction occurring either in the Community or in a third country. CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 4 / 14 Manufacturing authorisations and inspection status The manufacturing site of the active substance and the manufacturing site for the finished product are located in the European Union (EU) . Batch release for the EU will be carried out by Chanelle Pharmaceuticals Manufacturing Ltd, Ireland .
All relevant sites have valid manufact uring authorisations. Good Manufacturing Practice ( GMP) compliance of the manufacturer of the active substance is claimed by the applicant by a declaration from the qualified person at the site for batch release and relies on an on-site performed by Chanel le Pharmaceuticals Manufacturing Ltd, Ireland in November 2014. Overall conclusions on administrative particulars The detailed description of the pharmacovigilance system and the GMP certification of the manufacturing sites were considered in line with leg al requirements. Part 2 - Quality Composition Inflacam 330 mg granules for horses is a pale yellow granular powder for oral administration. This product has been formulated in a way that has been found to be bioequivalent to Metacam 15 mg/ml oral suspensio n for horses . Both contain the active ingredient meloxicam, however in different concentrations and with different excipients. The proposed new pharmaceutical form contains the following excipients: glucose monohydrate, apple flavour, crospovidone and povi done. The excipients are considered common for this type of dosage form and are therefore acceptable. A corresponding Metacam formulation is not available. Container Inflacam 330 mg granules for horses is presented in paper foil sachets containing 1500 mg of finished product and is available in a pack size of 100 sachets in a cardboard box. The finished product is a single -dose product. Development pharmaceutics Inflacam 330 mg granules for horses was developed to be bioequivalent to Metacam 15 mg/ml oral suspension for horses . The applicant has submitted a n in vivo bioequivalence study with Metacam 15 mg/ml oral suspension for horses as the reference product. Both products Inflacam 330 mg granules and Metacam 15 mg/ml oral suspension for horses can be admin istered mixed with food, but the granules may be more readily mixed into food than the suspension. Furthermore, the granules are presented in sachets that allow administering the same amount of active substance to the horse from a smaller volume of packagi ng. An apple flavour is included in the formulation but the finished product is not considered palatable. This excipient is included into the formulation in order to facilitate the administration of the finished product. CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 5 / 14 The finished product is intended to be administ ered mixed with food. There is no incompatibility of the product with the food used in the bioequivalence study. The type of food (typical muesli) used in the bioequivalence study is considered representative of food usually given to horses . Comparative impurity data of Inflacam 330 mg granules versus Metacam 15mg/ml oral suspension were presented. The level of identified impurities, as well as the level of individual unknown and total impurities is similar between these two products.
Method of manufacture The finished product is manufactured according to a standard process (wet granulation) . The description of the manufacturing process and the level of detail provided are considered satisfactory. Appropriate in-process controls have been set to monitor the manufacturing process and ensure it is controlled. The validation of the manufacturing process has been satisfactorily conducted on two industrial scale batches on the smallest commercial batch size for this product. The complete validation on commercial scale batches will be performed at the manufacturing site declared for commercial batches . This is considered acceptable. Control of starting materials Active substance The active substance, meloxicam, is described in the European Pharmacopo eia (Ph. Eur.) and is manufactured in the EU. An active substance master file was provided which has been assessed previously for the initial marketing authorisation of Inflacam . A new version of the restricted part is available and the changes proposed wi thin this new version are acceptable . The proposed retest period for the active substance is 5 years, stored in polyethylene bags in fibre drums. Results from storage of batches of the substance for up to 60 months at 25 °C / 60% RH and for 6 months at 40 ° C/75% RH are available. No relevant changes were observed. The proposed retest period is considered acceptable. Excipients All the excipients are the subject of a monograph of the Ph. Eur. except the apple flavour for which supplier’s data on its composition are provided. An appropriate specification has been set for this excipient. Certificates of analysis from the finished product and the excipients manufacturers have been provided for each component. The results comply with the specifications. Specific m easures concerning the prevention of the transmission of animal spongiform encephalopathies None of the starting materials used for the active substance meloxicam or the finished product are risk materials as defined in the current version of the Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 Rev.3). CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 6 / 14 TSE declarations for each component of the finished product (active substance and excipients) have been provided by the respective manufacturer and the manufacturer of the finished product. Control tests during production Not applicable. Control tests on the finished product The product specification includes tests for appearance (visual), identity and assay of meloxicam (HPLC), weight, moisture (Ph. Eur.), uniformity of dosage units (Ph. Eur.), identity of flavour (organoleptic), microbial purity (Ph. Eur.) and particle size distribution. The proposed test parameters and limits are considered acceptable. The analytical methods used in the control of the finished product are validated , when necessary, and are considered acceptable . The results of the analysis of two production scale batches of finished product were presented which comply with the proposed spec ification. Stability Results from stability studies with two production scale batches of the finished product are available at long term conditions (25 °C /60% RH) for 24 months and accelerated conditions (40 °C /75% RH) for 6 months . The shelf -life specific ation is the same as at release except that limits for related substances have been established at the end of shelf -life. Based on the stability data provided, extrapolation of long term data from 24 months up to 36 months is justified and the proposed shelf -life of 3 years is considered acceptable. No photostability study is presented. However, as the granules are filled into opaque sachets which are considered suitable for the protection of the finished product t his is considered acceptable. After mixing into food, the finished product has to be administer ed immediately and has not to be stored. A recommendation in this regard is included in the product literature. The proposed shelf -life of 3 years without any special storage conditions is acceptable. Ove rall conclusions on quality The dossier provides a suitable description of the formulation and demonstrates that the manufacturing process leads to a stable product with consistent quality. All the components of the finished product are the subject of a monograph in the Ph. Eur. except the apple flavour for which an appropriate specification has been set. The finished product is manufactured by wet granulation which is a standard process. Complete process validation on commercial scale batches will be perf ormed at the site of manufacture of the commercial batches. CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 9 / 14 MRLs The active substance in Inflacam is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No. 37/2010: Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Therapeutic classification Meloxicam Meloxicam Bovine, caprine, porcine, rabbit, Equidae 20 μ g/kg 65 μ g/kg 65 μ g/kg Muscle Liver Kidney NO ENTRY

Anti

inflammatory agents/Non -steroidal anti -inflammatory agents Bovine, caprine 15 μg/kg Milk The excipients listed in section 6.1 of the SPC, with the exception of apple flavour, are either allow ed substances for which table 1 of the annex to Commission Regulation (EU) No. 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No. 470/2009 when used as in this product. Apple flavour is a br anded excipient and, as such, is neither included in table 1 of the annex to Regulation (EU) No. 37/2010, nor in the list of substances considered as not falling within the scope of Regulation (EC) No . 470/2009. The full qualitative and quantitative compos ition of the flavour was provided and the CVMP considers that this excipient does not pos e a risk to the consumer. Withdrawal periods No residue depletion studies were provided. The applicant referred to the bioequivalence study performed with Inflacam 330 mg granules and Metacam 15 mg/ml oral suspension for horses . As bioequivalence with the reference product w as shown, and as the product is to be administered orally, no new confirmatory local residue studies would be necessary. According to the CVMP Note for guidance: Approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95- FINAL) and the CVMP Guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00- Rev.2) confirmatory local residue studies, in th e case of a generic application, are required only for parenterally administered products via intramuscular or subcutaneous route. The test and reference products were administered in the same way, i.e. mixed with the same amount of feed. From the results of this study, the bioequivalence between the two products is demonstrated. The withdrawal period proposed by the applicant is the same as that of the reference product (meat and offal: 3 days) and is considered acceptable. In addition, the following sentence is included in section 4.11 of the SPC: " Not authorised for use in lactating animals producing milk for human consumption ".
Overall conclusions on the residues documentation The MRL status of the active substance and the excipients is considered to b e fully documented. In particular, the full qualitative and quantitative composition of the apple flavour was provided and the CVMP considers that this excipient does not pos e a risk to the consumer. CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 10 / 14 The proposed withdrawal period for meat and offal of 3 days is accepted as the bioequivalence with an appropriate reference product is demonstrated. The product is n ot authorised for use in lactating animals producing milk for human consumption . Part 4 – Efficacy This extension application is to add a new stre ngth and pharmaceutical form of meloxicam, i.e. 330 mg of meloxicam per sachet in the form of granules, for the existing target species horses. In support of this application, an in vivo bioequivalence study was performed in horses following sin gle oral ad ministration of 0.60 mg of meloxicam/kg bw comparing Inflacam 330 mg granules for horses and Metacam 15 mg/ml oral suspension for horses as reference product . This GLP study was satisfactory and performed according to the requirements of the CVMP Guideline on the conduct of bioequivalence studies for veterinary medicinal products ( EMA/CVMP/016/00- Rev.2 ). The test and reference products were administered mixed with the same amount of feed. From the results of this study, the bioequivalence between the two pr oducts is demonstrated. Pharmacodynamics 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 effe cts. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen -induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase -2 (COX- 2) to a greater extent tha n cyclooxygenase -1 (COX- 1). Development of resistance Not applicable. Pharmacokinetics A GLP -compliant bioequivalence study was performed in the Czech Republic in 2014 with 24 horses receiving Inflacam 330 mg granules for horses and Metacam 15 mg/ml oral s uspension for horses , the test and reference products respectively.
The study was performed according to the requirements in the CVMP Guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00- Rev.2) . It is a sin gle- dose, two -period, two -sequence, cross- over bioequivalence study with a 15 -day wash -out period. The test and the reference products were administered at the recommended dose of 0.60 mg of meloxicam/kg bw mixed with the same amount of feed. The product w as administered into the trough thoroughly mixed together with small amount of muesli feed (approximately 250 g) that is typically used at the test s ite. Consumption of the whole dose and its swallowing were checked. The whole administered product with mue sli feed was consumed always within 2 –3 minutes. A s ingle dose of the product was administered at each period. CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 11 / 14 Blood samples were stored frozen and the sampling times were pre- dose and at appropriate time intervals post- dose. Physical examination and clinical observation focused on general tolerance, local tolerance and adverse events (AEs) of animals (general appearance, behaviour and appetite) were performed. No changes of clinical health, no local or general intolerance and no adverse events were observed. From the results of this study, the bioequivalence between the two products was considered to be established on the basis of the mean AUC falling in between the margins of the reference product (81.7%– 113.2%; 90% CI ) and C max falling in between the marg ins of the reference product (83.1%– 111.9%; 90% CI). Dose determination/justification Not applicable . Target animal tolerance No specific tolerance study has been conducted with the Inflacam 330 mg granules for horses .
In the pivotal bioequivalence study with Metacam 15 mg/ml oral suspension f or horses both products were administered mixed with feed and there were no issues with the administration. Apple flavour is present in the test product but not in the reference product Metacam ; however, there were no differences reported in the bioequivalence study with the administration of both products. The presence of the apple flavour did not have a negative effect on the palatability. Inflacam 330 mg granules for horses, is a more concentrated formulation of meloxicam than Metacam 15 mg/ml oral suspension for horses . One important side effect of local tolerance of NSAIDs is whether the active substance is carried to the right dorsal colon where it can exert a direct toxic effect (e.g. right dorsal colitis). This is well described for other types of NSAIDs. A more concentrated formulation of meloxicam could have a similar effect whereby significant amounts could be carried to the right dorsal colon and exert a direct toxic effect. This is independent of the dose since a lower amount, in a more concentrated formulation, could be carried to the right dorsal colon to exert the toxic effect. The applicant provided a relevant review of published literature that shows no reports of any issues with tolerance with meloxicam when used in horses. Furthermore, the tolerance of Inflacam 330 mg granules for horses was followed in the pivotal bioequivalence stud y and no adverse effects were reported. Tolerance in horses of Inflacam 330 mg granules was also followed in another bioe quivalence study with Rheumocam 15 mg/ml oral suspension as reference product and no adverse effects were reported either in this study. This bioequivalence study is not considered pivotal to conclude on bioequivalence as the reference product used is not appropriate because it is a generic but the data is still be valuable to conclude on safety aspects of Inflacam 330 mg granules for horses. Thus, this new more concentrated form of meloxicam can be expected to be well tolerated locally in the intestines of horses over time (14 days of consecutive administration is claimed). In order to minimise the risk of intolerance due to a greater concentration of meloxicam section 4.9 of the SPC clearly states that “T he product should be added to 250 g of muesli feed, prior to feeding”, as per the conditions in the bioequivalence study. The product is packaged as a single -dose sachet and as such administration to the horse cannot be done according to the bodyweight of the horse. Therefore, the use of the product is rest ricted, as a single -dose CVMP assessment report for Inflacam 330 mg granules in sachet for horses (EMEA/V/C/002497/X/0009) EMA/674069/2015 Page 12 / 14 product, to adult horses weighing between 500 kg and 600 kg. This restriction allow s a precise dosage for adult horses as for the reference product. Without this restriction the dosing band would be much greater than that for the r eference product.
The information relating to contraindications, adverse effects, precautions for use, interactions and overdose included on the proposed SPC for Inflacam 330 mg granules for horses is the same as that included on the SPC of the reference product. Inflacam 330 mg granules for horses is contraindicated in pregnant or lactating mares, in foals less than 6 weeks old and in horses suffering from gastrointestinal disorders because the safety is not documented. Taking into account that the produc t is an oral dos age form, bioequivalence was tested versus Metacam 15 mg/ml oral suspension for horses where no adverse events or intolerance were reported, the toxicological profile of the active substance is well known and has been adequately characteris ed in the published literature and that the excipients ar e recognised as being non -toxic, the CVMP concluded that the absence of tolerance studies with Inflacam 330 mg granules is acceptable. Overall conclusion on efficacy A GLP bioequivalence study was performed in horses following sin gle oral administration of 0.60 mg of meloxicam/kg bw with Inflacam 330 mg granules for h orses and Metacam 15 mg/ml oral suspension for horses. The choice of the reference product is considered appropriate and the bioequivale nce is accepted. This bioequivalence study supports the indication “For the alleviation of inflammation and relief of pain in both acute and chronic musculo -skeletal disorders in horses ” as authorised for the reference product Metacam 15 mg/ml oral soluti on for horses. Inflacam 330 mg granules for horses is a single -dose product restricted to horses weighing between 500 kg and 600 kg in order to achieve a precise dosing range along the lines of the reference product. The CVMP concluded that the product is well tolerated when used according to the SPC. Part 5 – Benefit -risk assessment Introduction The application for Inflacam 330 mg granules for horses is an extension application to add a new strength (330 mg) and a new pharmaceutical form (granules in sache t) for the existing target species horses.
The applicant based their application upon bioequivalence with Metacam 15 mg/ml oral suspension for horses. The proposed indication is: a lleviation of inflammation and relief of pain in both acute and chronic mus culo -skeletal disorders in horses weighing between 500 and 600 kg. The proposed withdrawal period s for meat and offal of 3 days is accepted. The product is n ot authorised for use in lactating animals producing milk for human consumption .

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