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Date: Sunday, July 14, 2024 2:07

Release 2.33
Inflacam 15mg/mL oral suspension for horses
 
Species: Horses only
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.
Incorporating:
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