Introduction

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

Each ml of Flexicam 1.5 mg/ml oral suspension for dogs contains 1.5 mg meloxicam as active ingredient (equivalent to 0.05 mg per drop).

Uses

Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.

Dosage and administration

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.

Shake well before use. To be administered mixed with food.

The suspension can be given using either the drop dispenser (for very small breeds) or the Flexicam measuring syringe provided in the package.

The dispenser provides 0.05 mg Meloxicam per drop (i.e. a dose of 0.1 mg Meloxicam/kg body weight corresponds to 2 drops/kg body weight). The syringe fits onto the bottle and has a kg - body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg/kg body weight). Thus, for the first day, twice the maintenance volume will be required.

Dosing procedure using the measuring syringe:

1. Shake bottle well. Push down and unscrew bottle top. Attach the dosing syringe to the bottle by gently pushing the end onto the top of the bottle.

2. Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to your dog's body weight in kilograms.

3. Turn the bottle the right way up and with a twisting movement, separate the dosing syringe from the bottle.

4. By pushing the plunger in, empty the contents of the syringe onto the food.

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.

Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.

Contra-indications, warnings, etc

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, or where there is evidence of individual hypersensitivity to the product.

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

If side effects 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.

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Flexicam 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 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.

In case of overdosage, symptomatic treatment should be initiated.

Adverse reactions: Typical adverse drug 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.

If you notice any other side effects, please inform your veterinary surgeon.

Operator warnings: 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 insert or label to the physician.

General precautions: For animal treatment only.

Pharmaceutical precautions

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the carton and the bottle.

Shelf life of opened bottle: 9 months.

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

Legal category

POM-V

Packaging Quantities

Polyethylene bottles containing 10 ml, 32 ml or 100 ml with a polyethylene dropper, a tamper-proof child resistant closure and a polypropylene measuring syringe.

Further information

Manufacturer: Fisher Clinical Services UK Limited, Langhurstwood Road, Horsham, West Sussex, RH12 4QD, UK

Marketing authorisation number

EU/2/06/058/001 - 10 ml.

EU/2/06/058/002 - 32 ml.

EU/2/06/058/003 - 100 ml.