Acticam (meloxicam) – Package leaflet - QM01AC06

PACKAGE LEAFLET

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

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder

Manufacturer for batch release

Ecuphar NV

Ecuphar NV

Legeweg 157-i

Legeweg 157-i

B-8020 Oostkamp

B-8020 Oostkamp

Belgium

Belgium

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Acticam 5 mg/ml solution for injection for dogs and cats.

Meloxicam.

3.STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Meloxicam 5 mg/ml.

Ethanol anhydrous 150 mg/ml.

4.INDICATIONS

Dogs:

Alleviation 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.

5.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.

6.ADVERSE REACTIONS

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have been reported. In dogs, in very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have 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. In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

common (more than 1 but less than 10 animals in 100 animals)

uncommon (more than 1 but less than 10 animals in 1,000 animals)

rare (more than 1 but less than 10 animals in 10,000 animals)

very rare (less than 1 animal in 10,000 animals, including isolated reports).

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Dogs and cats.

8.DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg). Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).

Dogs

Musculo-skeletal disorders: single subcutaneous injection.

Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia.

Avoid introduction of contamination during use.

9.ADVICE ON CORRECT ADMINISTRATION

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

10.WITHDRAWAL PERIOD

Not applicable.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

This veterinary medicinal product does not require any special storage conditions. Shelf-life after first opening the container: 28 days.

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

12.SPECIAL WARNINGS

For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.

Special precautions for use in animals

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.

Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.

Special precautions to be taken by the person administering the product

Accidental self-injection may give rise to pain. People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal product.

In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.

Pregnancy / Lactation

See section “Contraindications”.

Interactions 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. Acticam 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.

Overdose (symptoms, emergency procedures, antidotes)

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

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

15.OTHER INFORMATION

Pack sizes:

Single 10 ml injection vial.

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