Janssen
Meloxivet 1.5 mg/ml oral suspension for dogs 10 ml

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs / Meloxicam

Some countries require a prescription to be issued for the sale of this drug.

Meloxivet 1.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Meloxivet 1.5 mg/ml

One ml contains:

Active substance:

Meloxicam 1.5 mg

Excipient:

Sodium benzoate 1 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM OF Meloxivet 1.5 mg/ml

Oral suspension. White to yellowish opaque suspension.

4. CLINICAL PARTICULARS OF Meloxivet 1.5 mg/ml

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 dogs.
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

None.

4.5 Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive dog, 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.

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, haematemisis, 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 the veterinarian should be sought.

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).

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. Meloxivet must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Pre- treatment with anti-inflammatory substances may result in additional or increased adverse reactions 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 pharmacological properties of veterinary medicinal products used previously.

4.9 Amounts to be administered and administration route

Oral use.
Shake well before use.
To be administered with food.

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 (24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

Particular care should be taken with regard to the accuracy of dosing.
The suspension has to be given with the measuring syringes provided in the package of the 30 ml and 150 ml pack size or with one of the two measuring syringes provided in the package of the 10 ml pack size. 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 the first day, twice the maintenance volume will be required.

The suspension of the 10 ml pack size could be administered using the smallest syringe for dogs less than 8 kg body weight (one graduation corresponding to 0.5 kg of body weight) or the largest syringe for dogs over than 8 kg body weight (one graduation corresponding to 2.0 kg of body weight).

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.
For longer term treatment once clinical response has been observed (after 4 or more days), the dose of Meloxivet 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. 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 OF Meloxivet 1.5 mg/ml

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic 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 6.1 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 of meloxicam 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 1/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 of meloxicam is eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS OF Meloxivet 1.5 mg/ml

6.1 List of excipients

Microcrystalline cellulose
Xanthan gum
Carboxymethylcellulose
Sodium benzoate
Sodium saccharinate
Glycerol
Sorbitol
Citric acid monohydrate
Sodium hydroxide
Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 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.

14.00
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on Tuesday 6 December
AIR FREIGHT

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