1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Meloxidyl 1.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Composition for 1 ml

Active substance (s)

Meloxicam 1.5 mg

Excipients

Sodium benzoate 2 mg

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Pale yellow suspension.

4. CLINICAL PARTICULARS

4.1Target species

Dogs.

4.2Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.

4.3 Contraindications

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.

4.4Special warnings for each target species

None.

4.5 Special precautions for use

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.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- 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 (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 period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non steroids. ATC-vet: 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

Xanthan gum

Silica colloidal anhydrous

Sorbitol liquid non-crystallising

Glycerol, xylitol

Sodium benzoate Citric acid anhydrous Purified water.

6.2 Major incompatibilities

Not applicable.

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.

6.5 Nature and composition of immediate packaging

Material of the primary container

High density polyethylene bottle with high density polyethylene tamper evidence screw cap. Low density polyethylene syringe insert for the polypropylene measuring syringes.

Pack sizes

Two measuring syringes are provided per each presentation.

10 ml bottle in a cardboard box

32 ml bottle in a cardboard box

100 ml bottle in a cardboard box

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products 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

Ceva Santé Animale

10 avenue de la Ballastière

33500 Libourne

France

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/070/001

EU/2/06/070/002

EU/2/06/070/003

9. DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15.01.2007

Date of last renewal: 19.12.2011

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.