Acticam (meloxicam) – Package leaflet - QM01AC06
Updated on site: 08-Feb-2018
- 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
- 2. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
- 4. INDICATIONS
- 5. CONTRAINDICATIONS
- 6. ADVERSE REACTIONS
- 7. TARGET SPECIES
- 8. DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
- 9. ADVICE ON CORRECT ADMINISTRATION
- 10. WITHDRAWAL PERIOD
- 11. SPECIAL STORAGE PRECAUTIONS
- 12. SPECIAL WARNINGS
- 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
- 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
- 15. OTHER INFORMATION
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
2.NAME OF THE VETERINARY MEDICINAL PRODUCT
Acticam 5 mg/ml solution for injection for dogs and cats.
3.STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Meloxicam 5 mg/ml.
Ethanol anhydrous 150 mg/ml.
Alleviation of inflammation and pain in both acute and chronic
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.
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.
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).
Avoid introduction of contamination during use.
9.ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing.
11.SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use after the expiry date stated on the carton and the vial.
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.
Special precautions to be taken by the person administering the product
In case of accidental
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.
Overdose (symptoms, emergency procedures, antidotes)
In the case of over dosage symptomatic treatment should be initiated.
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/.
Single 10 ml injection vial.