Meloxicam Ceva 0.5 mg/ml Oral Suspension for Cats

Composition

One ml contains:

Active substance:

Meloxicam 0.5 mg

Excipient:

Sodium benzoate (E 211) 2.0 mg

For the full list of excipients, see section 6.1

6.1 List of excipients

Xanthan gum

Silica colloidal anhydrous

Sorbitol liquid non-crystallising

Glycerol

Xylitol

Sodium benzoate (E 211)

Citric acid anhydrous

Purified water

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Pharmaceutical form

Oral suspension.

Pale yellow suspension.

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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 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. 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 and there are no pharmacologically active metabolites.

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. 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

Cats.

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Indications

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

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

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Dosage

Post-operative pain and inflammation following surgical procedures:

After initial treatment with meloxicam 2 mg/ml solution for injection for cats, continue treatment 24 hours later with the veterinary medicinal product at a dosage of 0.05 mg meloxicam/kg bodyweight. 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 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.

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.

Route and method of administration

Shake well before use. To be administered orally either mixed with food or directly into the mouth. The suspension can be given using the measuring syringe provided in the package.

The syringe fits onto the bottle and has a kg-body weight scale (from 1 kg to 10 kg) which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.

Avoid introduction of contamination during use.

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Contraindications

- Do not use in pregnant or lactating animals.

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

- Do not use in cats less than 6 weeks of age.

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Adverse reactions

Cats:

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 its local representative or the national competent authority via the national reporting system. See also section “Contact details” of the package leaflet for respective contact details.

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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 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

Meloxicam and other non-steroidal anti-inflammatory drugs (NSAIDs) may cause hypersensitivity (allergic reactions).

People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

Accidental ingestion of the product by a child may cause gastro-intestinal effects, such as nausea and gastric pain.

Any uneaten medicated food must be disposed of immediately and the bowl washed thoroughly.

Do not leave an unattended filled syringe in the sight or reach of children. In case of accidental ingestion, 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.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

Other precautions

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 section 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.

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 veterinary medicinal 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 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

Material of the primary container

High density polyethylene bottle with high density polyethylene tamper evident screw cap, with low density polyethylene syringe insert for the polypropylene measuring syringe.

Type III glass bottle with high density polyethylene tamper evident screw cap, with low density polyethylene syringe insert for the polypropylene measuring syringe.

Pack sizes

Cardboard box containing 15 ml high density polyethylene bottle with one measuring syringe.

Cardboard box containing 5 ml glass bottle with one measuring syringe.

The measuring syringe has a kg-body weight scale for cats (1 to 10 kg).

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: 30 months

Shelf life after first opening the immediate packaging: 6 months

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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 14966/5006

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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