NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Thursday, May 30, 2024 6:49

Release 2.28
Inflacam 1mg and 2.5mg chewable tablets for dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other NSAIDs
Active ingredient: Meloxicam
Product:Inflacam 1mg and 2.5mg chewable tablets for dogs
Product index: Inflacam 1mg and 2.5mg chewable tablets for dogs
Incorporating:
Qualitative and quantitative composition
One chewable tablet contains:
Active substance:
Meloxicam 1 mg
Meloxicam 2.5 mg.
For the full list of excipients, see section 6.1.
Pharmaceutical form
Chewable tablets.
Pale-yellow, single-scored, chewable tablets.
The tablet can be divided into equal halves.
Clinical particulars
Target species
Dogs
Indications for use
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Contra-indications
Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
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 increased renal toxicity.
This product for dogs should not be used in cats as it is not suitable for use in this species.
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 the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported.
In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Interactions
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Inflacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such medicines should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Amounts to be administered and administration route
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.
Each chewable tablet can be halved for accurate dosing according to the individual body weight of the animal.
Inflacam chewable tablets can be administered with or without food, are flavoured and are taken by most dogs voluntarily.
The use of Inflacam oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of Inflacam oral suspension for dogs is recommended.
A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.
Overdose
In case of overdose symptomatic treatment should be initiated.
Withdrawal periods
Not applicable
Pharmacological particulars
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QMO1AC06.
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. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-l (COX-I).
Pharmacokinetic properties
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains 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.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.
Pharmaceutical particulars
Excipients
Lactose monohydrate
Silicified microcrystalline cellulose
Sodium acid citrate
Crospovidone
Talc
Pork flavour
Magnesium stearate
Major incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Immediate packaging
PVC/PVDC blister packs with a 20 micron foil.
Pack sizes: 20 and 100 tablets.
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 Ltd.,
Loughrea,
Co. Galway,
Ireland
Marketing Authorisation Number
1mg tablets
GB: VM 08749/5009
2.5mg tablets
GB: VM 08749/5012
NI:
EU/2/11/134/011
EU/2/11/134/012
EU/2/11/134/013
EU/2/11/134/014
Significant changes
Date of the first authorisation or date of renewal
09/12/2011
Date of revision of the text
Detailed information on this product is available on the website of the European Medicines Agency (EMA) (http://www.ema.europa.eu).
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Inflacam 1mg chewable tablets for Dogs x 100
GTIN:5099299028364
GTIN description:Inflacam 2.5mg chewable tablets for Dogs x 100
GTIN:5099299028357