Inflacam
Active substance
ATC code
Species
Dogs.
Indications
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Dose to be administered and administration route
Oral use.
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.
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of the veterinary medicinal product can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
To ensure a correct dosage, body weight should be determined as accurately as possible. The use of suitably calibrated measuring equipment is recommended.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the measuring syringe provided in the package of the veterinary medicinal product. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight). Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
A clinical response is normally seen within 3 to 4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
Adverse reactions
Dogs:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Appetite loss, Lethargy Vomiting, Diarrhoea, Blood in faeces1, Haemorrhagic diarrhoea, Haematemesis, Gastric ulcer, Small intestine ulcer, Large intestine ulcer Elevated liver enzymes Renal failure |
1occult.
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.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – VeterinarianReferences
TRUSTED SOURCE
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Inflacam 1.5 mg/ml oral suspension for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance
Meloxicam 1.5 mg
Excipient
Sodium benzoate 5 mg.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Oral suspension.
A yellow coloured suspension.
4. CLINICAL PARTICULARS
4.1 Target species
Dogs.
4.2 Indications for use, specifying the target species
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
4.3 Contraindications
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 case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs 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.
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Inflacam 0.5 mg/ml oral suspension for cats should be used.
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)
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.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
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 veterinary medicinal products 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 veterinary products used previously.
4.9 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.
For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Inflacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Particular care should be taken with regard to the accuracy of dosing.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the Inflacam measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight). Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.
A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Avoid introduction of contamination during use.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawal period(s)
Not applicable.
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. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 7.5 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.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Saccharin sodium
Sodium carboxyl methyl cellulose
Colloidal silicon dioxide Citric acid monohydrate
Sorbitol solution
Disodium hydrogen-phosphate dodecahydrate
Sodium benzoate Honey flavour
Purified water.
6.2 Major incompatibilities
None known.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 6 months.
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
15 ml HDPE bottle with a tamper resistant child proof closure or 42, 100 or 200 ml polyethylene terephthalate (PET) bottle with a tamper resistant child proof closure and two polypropylene measuring syringes: one for small dogs (up to 20 kg) and one for bigger dogs (up to 60 kg).
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 Ltd.,
Loughrea, Co. Galway, Ireland.
8. MARKETING AUTHORISATION NUMBERS
EU/2/11/134/001 15 ml
EU/2/11/134/002 42 ml
EU/2/11/134/003 100 ml
EU/2/11/134/004 200 ml
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 09/12/2011
Date of latest renewal: 09/11/2016
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.
| Art. Nr. | |
|---|---|
| EAN | 5099299028326 |
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