Meloxicam Ceva 5 mg/ml Solution for Injection for Dogs and Cats

Composition

Composition for 1 ml

Active substance

Meloxicam 5 mg

For the full list of excipients, see section 6.1

6.1 List of excipients

Ethanol, anhydrous

Poloxamer 188

Glycofurol

Meglumine

Glycine

Sodium chloride

Sodium hydroxide

Hydrochloric acid, concentrated

Water for injections

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Pharmaceutical form

Solution for injection

Clear yellow solution.

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Pharmacological properties

ATC-vet 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

Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 μg/ml in dogs and 1.1 μg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs. More than 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.

Metabolism

In dogs, 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.

In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.

Elimination

In dogs, 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. In cats, 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. 21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

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Target species

Dogs and cats

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Indications

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

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Dosage

Dogs:

Musculo-skeletal disorders:

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).

Meloxicam Ceva 1.5 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Reduction of post-operative pain (over a period of 24 hours):

Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cats:

Reduction of post-operative pain:

Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.

Particular care should be taken with regard to the accuracy of dosing.

Avoid introduction of contamination during use.

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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 known cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.

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Adverse reactions

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Anaphylactoid reaction, Vomiting¹, Diarrhoea¹, Blood in faeces¹, Appetite loss¹, Apathy¹, Renal failure¹

Cats:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Anaphylactoid reaction, Vomiting¹, Diarrhoea¹, Blood in faeces¹, Appetite loss¹, Apathy¹, Renal failure¹

¹These side effects disappear following termination of the treatment but in very rare cases may be serious or fatal.

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 the national competent authority via the national reporting system. See also the last section ‘Contact details’ of the package leaflet

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Warnings

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 increased renal toxicity.

Any oral follow-up therapy using meloxicam or other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.

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

Accidental self-injection may give rise to pain.

People with known hypersensitivity to non- steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

This product can cause eye irritation. In case of contact with the eyes immediately rinse thoroughly with water.

Special precautions for the protection of the environment:

Not applicable.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3).

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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. The veterinary medicinal product must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided.

In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

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.

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Overdose

In the 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

Colourless type I glass injection vial of 10 ml, closed with a grey EPDM (Ethylene Propylene Diene Monomer) or flurotec rubber stopper and sealed with a flip off violet aluminium seal in a cardboard box.

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Storage

Do not store above 25°C.

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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: 28 days.

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Disposal of unused product

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

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Additional information

Vm 14966/5008

9 DATE OF FIRST AUTHORISATION

12 June 2024

10 DATE OF REVISION OF THE TEXT

September 2025

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Gavin Hall Approved: 26 September 2025

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Registration holder

Ceva Sante Animale

8 rue de Logrono

33500 Libourne

France

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