SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Meloxaid 0.5 mg/ml oral suspension for cats.

2. Qualitative and quantitative composition

Each ml contains:

Active Substance:

Meloxicam 0.5 mg

Excipient:

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

Cats.

4.2 Indications for use, specifying the target species

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

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

4.3 Contraindications

Do not use in pregnant or lactating cats.

Do not use in cats 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 cats 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.

Post-operative pain and inflammation following surgical procedures:

In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders:

Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

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 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. Concurrent administration of potential nephrotoxic drugs should be avoided.

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 pharmacological 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.

Dosage

Post-operative pain and inflammation following surgical procedures:

After initial treatment with Meloxaid 5 mg/ml Solution for Injection for Dogs and Cats continue treatment 24 hours later with Meloxaid 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:

Initial treatment is a single oral 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 dose of 0.05 mg meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:

Initial treatment is a single dose of 0.1 mg meloxicam/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 0.05 mg meloxicam/kg bodyweight.

A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.

Dosing Procedure:

The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the treatment of chronic musculo-skeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be required.

Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded. The suspension should be given using the Meloxaid measuring syringe provided in the package.

Avoid introduction of contamination during use.

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

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels. In the case of overdose, adverse reactions (as listed in Section 4.6) are expected to be more severe and more frequent. In the case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. pharmacological properties

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 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

If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed. Due to the loading dose, steady is reached after 2 days (48h).

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.

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: 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

The veterinary medicinal product is presented in 5 ml, 15 ml and 30 ml polyethylene terephthalate screw bottles with HDPE/LDPE child resistant caps. The 1 ml measuring syringe has a kg-body weight scale for cats (0.5 to 10 kg).

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material 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

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

United Kingdom

8. MARKETING AUTHORISATION NUMBER

Vm 02000/4395

9. DATE OF FIRST AUTHORISATION

11 February 2016

10. DATE OF REVISION OF THE TEXT

February 2016

Approved: 11/02/2016