Flexicam - summary of medicine characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Flexicam 5 mg/ml solution for injection for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITIONOne ml contains

Active substance:

Meloxicam 5 mg

Excipients:

Ethanol, anhydrous 150 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection. Clear yellow solution

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats.

4.2 Indications for use, specifying the target species

Dogs: A lleviation 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.

4.3 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 case 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.

Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for repeated oral administration has been established.

4.4 Special warnings for each target species

4.5 Special precautions for use

If side effects occur, treatment should be discontinued.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential ris increased renal toxicity.

Accidental self-injection may give rise to pain.

People with known hypersensitivity to meloxicam should avoid contact with th product.

In case of accidental self-injection, seek medical advice immediately an the label to the physician.

• 4.6 Adverse reactions (frequency and seriousness)

  
  

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

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal lactation (see 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

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. 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.

4.9 Amounts to be administered and administration route

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).

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 bod 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of over dosage symptomatic treatment should be initiated.

4.11 Withdrawal periods

Not applicable.

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5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).

ATCvet 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:                        y

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

Distribution:

There is a linear relationsheen 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.

is predominantly found in plasma and is also a major biliary excretion product ontains only traces of the parent compound. Meloxicam is metabolised to an alcohol, and to several polar metabolites. All major metabolites have been shown to be lly inactive.

Elimination:

Meloxicam is eliminated with a half-life of 24 hours in dogs and 15 hours in cats. Approximately 75% ministered dose is eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Ethanol anhydrous

Poloxamer 188

Glycofurol

Meglumine

Glycine

Sodium Chloride

Sodium Hydroxide

Water for injection

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and composition of immediate packaging

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

7. MARKETING

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION