Do not use in dogs less than 10 weeks of age.
Do not use in dogs suffering from gastrointestinal disorders or haemorrhagic disorders.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory medicinal products (NSAIDs).
Do not use in case of hypersensitivity to cimicoxib or to any of the excipients.
Do not use in breeding, pregnant and lactating animals.
Special Warnings: None.
Special precauctions for use in animals:
Since the safety of the medicinal product has not been adequately demonstrated in young animals, careful monitoring is advised during the treatment of young dogs aged less than 6 months.
Use in animals suffering from impaired cardiac, renal or hepatic function, may involve additional risk. If such use cannot be avoided, these animals require careful veterinary monitoring.
Avoid using this product in any animals which are dehydrated, hypovolaemic or hypotensive, as it may increase the risk of renal toxicity.
Use this veterinary medicinal product under strict veterinary monitoring where there is a risk of gastrointestinal ulceration, or if the animal previously displayed intolerance to NSAIDs.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Cimicoxib may cause skin sensitisation. Wash hands after use.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
People with a known hypersensitivity to cimicoxib should avoid contact with the veterinary medicinal product.
Adverse reactions (frequency and seriousness)
Mild and transient gastro-intestinal disorders (vomiting and/or diarrhoea) were very commonly reported.
On rare occasions, serious gastrointestinal disorders such as haemorrhage and ulcer formation have been noted. Other adverse reactions including anorexia or lethargy may also be observed on rare occasions.
In very rare cases, increases in renal biochemistry parameters were noted. Furthermore, in very rare cases, renal failure has been reported. As for any long term NSAID treatment, renal function should be monitored.
If any observed adverse effect persists after stopping treatment, the advice of a veterinarian should be sought.
If adverse reactions such as persistent vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy or worsening of renal or hepatic biochemistry parameters occur, use of the product should be discontinued and appropriate monitoring and/or treatment should be put in place.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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).
Use during pregnancy, lactation or lay
Do not use in breeding, pregnant or lactating bitches. Although no data are available in dogs, studies with laboratory animals have shown effects on their fertility and foetal development.
Interaction with other medicinal products and other forms of interaction
Cimalgex should not be administered in conjunction with corticosteroids or other NSAIDs. Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such medicinal products should be observed before the commencement of treatment with Cimalgex. The treatment-free period should take into account the pharmacokinetic properties of the veterinary medicinal product used previously.
Overdose
In an overdose study where 3 times (5.8 to 11.8 mg/kg body weight) and 5 times (9.7 to 19.5 mg/kg body weight) the recommended dose was administered to dogs for a period of 6 months, a dose related increase in gastrointestinal disturbances, which affected all dogs in the highest dose group, was noted.
Similar dose related changes to haematology and white blood cell counts, as well as renal integrity, were also noted.
As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs.
There is no specific antidote to this product. Symptomatic, supportive therapy is recommended consisting of administration of gastrointestinal protective agents and infusion of isotonic saline.
Withdrawal period
Not applicable.