Ceva
Meloxidyl 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.

Meloxidyl 1.5 mg/ml oral suspension for dogs.

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

Composition for 1 ml

Active substance (s)

Meloxicam 1.5 mg

Excipients

Sodium benzoate 2 mg

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM OF Meloxidyl 1.5 mg/ml

Pale yellow suspension.

4. CLINICAL PARTICULARS OF Meloxidyl 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.

4.3 Contra-indications

Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of individual hypersensitivity to the product.
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, including special precautions to be taken by the person administering the medicinal product to the animals

Special precautions for use in animals

If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, if there is a potential risk of increased renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to 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 drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally 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.

4.7 Use during pregnancy, lactation or lay

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

4.9 Amounts to be administered and administration route

Oral use.
Shake well before use.

To be administered mixed 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 (at 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 can be given using the measuring syringes 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 the first day, twice the maintenance volume will be required.
The suspension could be administered using the smallest syringe for dogs less than 7 kg body weight (one graduation corresponding to 0.5 kg of body weight) or the largest syringe for dogs over than 7 kg body weight (one graduation corresponding to 2.5 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.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdosage, symptomatic treatment should be initiated.

4.11 Withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero

Not applicable.

5. PHARMACOLOGICAL PROPERTIES OF Meloxidyl 1.5 mg/ml

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non steroids.

ATCvet: 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 collageninduced 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 OF Meloxidyl 1.5 mg/ml

6.1 List of excipients

Xanthan gum, silica colloidal anhydrous, sorbitol liquid non-crystallising, glycerol, xylitol, sodium benzoate, citric acid anhydrous, purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years
After first opening: 6 months.

6.4 Special precautions for storage

No special precautions for storage.

16.50
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on Friday 24 November
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