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Inflacam For Horses

  • Granules » 330mg Sachet » Pack of 100 £188.50
  • Granules » 330mg Sachet » Priced per Sachet £1.90
  • Oral Suspension » 15mg/ml » 100ml Bottle £19.99
  • Oral Suspension » 15mg/ml » 250ml Bottle £39.99
  • Oral Suspension » 20mg/ml » 100ml Bottle £91.49

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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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