SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Meloxaid 1.5 mg/ml oral suspension for dogs.

2. Qualitative and quantitative composition

Each ml contains:

Active Substance:

Meloxicam 1.5 mg

Excipients:

Sodium Benzoate 1.5 mg

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Oral suspension

Pale yellow 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 animals 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 no 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

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

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

Wash any splashes from skin immediately with water.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported. These adverse reactions 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 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. Meloxaid 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 products used previously.

4.9 Amounts to be administered and administration route

Oral use.

To be administered with food or directly into the mouth.

Shake well before use.

Initial treatment is a single dose of 0.2 mg meloxicam/kg bodyweight (i.e. 1.33 ml/10 kg bodyweight) 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 bodyweight (i.e. 0.667 ml/10 kg bodyweight).

For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose 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.

The suspension can be given using either of the two measuring syringes provided in the package (depending on weight of dog). The syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg bodyweight). Thus for the first day, twice the maintenance volume will be required. Alternatively therapy may be initiated with Meloxaid 5 mg/ml solution for injection.

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 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 vitroand in vivostudies 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 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 in dogs. 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

Sodium Benzoate

Glycerol

Povidone K30

Xanthan Gum

Disodium Phosphate Dihydrate

Sodium Dihydrogen Phosphate Dihydrate

Citric Acid Anhydrous

Simethicone Emulsion

Purified water

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months

Shelf-life after first opening the immediate packaging: 6 months

This veterinary medicinal product does not require any special storage conditions.

The veterinary medicinal product is presented in a cardboard box containing a 10 ml, 32 ml, 100 ml, 2 x 100 ml or 200ml polyethylene terephthalate screw bottles with HDPE/LDPE child resistant caps. Two polyethylene/polypropylene measuring syringes, a 1 ml and 5 ml syringe, are supplied with each presentation to ensure accurate dosing of small and large dogs. Each syringe is graduated in bodyweight, the 1 ml syringe is graduated from 0.5 kg to 15 kg and the 5 ml syringe for 2.5 kg to 75 kg.

Not all pack sizes may be marketed.

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

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 02000/4396

9. DATE OF FIRST AUTHORISATION

11 February 2016

10. DATE OF REVISION OF THE TEXT

February 2016

Approved: 11/02/2016