Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@jacgb.jnj.com

Qualitative and quantitative composition

Composition for 1 ml:

Active substance: Meloxicam 1.5 mg

Excipient: Sodium benzoate 1 mg

For a full list of excipients, see section 6.1.

Pharmaceutical form

Oral suspension. White to yellowish opaque suspension.

Clinical particulars

Target species

Dogs.

Indications for use

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

Contra-indications

Do not use in pregnant or lactating dogs.

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.

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

If side effects occur, treatment should be discontinued and the advice of the veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity.

Special precautions to be taken by the peron administering the 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.

Adverse reactions

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported.

These side effects 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.

Use during pregnancy, lactation orlay

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

Interactions

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxivet must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre- treatment with anti-inflammatory substances may result in additional or increased adverse reactions and accordingly a treatment-free period with such 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 veterinary products used previously.

Amounts to be administered and administration route

Oral use.

Shake well before use.

To be administered with food.

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 (24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

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

The suspension has to be given with the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (ie. 0.1 mg meloxicam/kg body weight). Thus for 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.

Overdose

In case of overdose symptomatic treatment should be initiated.

Withdrawal periods

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Anti-inflammatory and Antirheumatic products, Non-steroids.

ATCvet 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 properties

Absorption:

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 6.1 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 of meloxicam 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 1/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 of meloxicam is eliminated via faeces and the remainder via urine.

Pharmaceutical particulars

-

Excipients

microcrystalline cellulose

xanthan gum

carboxymethylcellulose

sodium benzoate

sodium saccharinate

glycerol

sorbitol

citric acid monohydrate

sodium hydroxide

purified water

Major incompatibilities

None known.

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.

Special precautions for storage

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

Immediate packaging

10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.

30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing authorisation number

EU/2/07/077/003 – 005.

Date of the first authorisation or date of renewal

14/11/2007

Date of revision of the text

14/11/2007

Any other information

Nil

Legal category

POM-V

Significant Changes