Meloxoral 1.5 mg/ml Oral Suspension for Dogs

Composition

Each ml contains:

Active substance:

Meloxicam 1.5 mg.

Excipient:

Sodium benzoate 1.75 mg.

For the full list of excipients, see section 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.

ATC Vet Code: QM01AC06

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).

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. 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.

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Target species

Dogs

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Indications

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

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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 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 maintenance dose of 0.1 mg meloxicam/kg body weight.

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

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Contraindications

Do not use in dogs 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 dogs less than 6 weeks of age.

See section 4.7.

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Adverse reactions

Dogs:

1 These 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. 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 increased renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Meloxoral 0.5 mg/ml oral suspension for cats should be used.

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.

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.

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

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 10 ml.

Cardboard box with one bottle of 25 ml.

Cardboard box with one bottle of 50 ml.

Cardboard box with one bottle of 125 ml.

Cardboard box with one bottle of 180 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 50406/5001

DATE OF FIRST AUTHORISATION

19 November 2010

DATE OF REVISION OF THE TEXT

May 2024

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

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

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Registration holder

Dechra Regulatory B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

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