Meloxoral 0.5 mg/ml Oral Suspension for Cats

Composition

Each ml contains:

Active substance:

Meloxicam 0.5 mg.

Excipient:

Sodium benzoate 1.75 mg.

For the full list of excipients, see section 6.1.

6.1 List of excipients

Sodium benzoate

Sorbitol

Glycerol

Polysorbate 80

Disodium phosphate dodecahydrate

Silica, colloidal anhydrous

Hydroxyethylcellulose

Citric acid monohydrate

Sodium cyclamate

Sucralose

Anise aroma

Water, purified

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Pharmaceutical form

Oral suspension.

Yellow/ green suspension.

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Pharmacological properties

Pharmacotherapeutic group: Musculo-skeletal system, antiinflammatory and antirheumatic products, non-steroids.

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

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.

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. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.

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Target species

Cats

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Indications

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

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Dosage

Oral use.

To be administered either mixed with food or directly into the mouth. Shake well before use.

Initial treatment is a single oral dose of 0.1 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 0.05 mg meloxicam/kg body weight.

Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.

The suspension can be given using the measuring syringe provided in the package. The syringe fits onto the drop dispenser of the bottle and has a kg- body weight scale which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.

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.

Avoid introduction of contamination during use.

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Contraindications

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.

See section 4.7.

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Adverse reactions

Cats:

Very Rare (<1 animal / 10,000 treated, including isolated reports):

Appetite loss¹, Apathy¹

Vomiting¹, Diarrhoea¹,

Renal failure¹

Elevated liver enzymes¹

Undetermined frequency (cannot be estimated from the available data):

Blood in faeces¹,²

¹ These adverse reactions 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 a veterinarian should be sought.

² occult

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

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 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.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

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

Do not use in pregnant or lactating animals.

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Interactions

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxoral must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic veterinary medicinal products 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 pharmacokinetic properties of the products used previously.

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Overdose

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.

In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

Cardboard box with 1 polyethylene bottle closed with a tamper proof child resistant closure and a polypropylene measuring syringe.

Pack sizes:

Cardboard box with one bottle of 5 ml.

Cardboard box with one bottle of 10 ml.

Cardboard box with one bottle of 25 ml.

Not all pack sizes may be marketed.

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Storage

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

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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.

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Disposal of unused product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. Medicines should not be disposed of via household waste.

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Additional information

Vm 50406/5000

9 DATE OF FIRST AUTHORISATION

19 November 2010

10 DATE OF REVISION OF THE TEXT

May 2024

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.

Approved 13 May 2024

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Registration holder

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

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