Target species
Dogs
Indications for use for each target species
For the treatment of pain and inflammation associated with osteoarthritis, and the management of peri- operative pain due to orthopaedic or soft tissue surgery, in dogs.
Contraindications
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 drugs (NSAIDs). Refer also to " Interaction with other medicinal products and other forms of interaction".
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in breeding, pregnant and lactating animals.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
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 veterinary medicinal 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
This veterinary medicinal product 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.
Special precautions for the protection of the environment
Not applicable.
Adverse events
Dogs:
Very common (>1 animal / 10 animals treated): | Vomiting1, Diarrhoea1 |
Rare (1 to 10 animals /10,000 animals treated): | Digestive tract haemorrhage2, Gastric ulceration2, Anorexia, Lethargy, Polyuria, Polydipsia |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Elevated renal parameters, Renal failure3 |
1 Mild and transient gastro-intestinal disorders
2 Serious gastro-intestinal disorders
3Kidney function should be monitored during long-term NSAID treatment.
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. As with other NSAIDs, serious adverse effects can occur and, in rare cases, may be fatal.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system.
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.
Cimicoxib 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 drugs should be observed before the commencement of treatment with Cimicoxib.
The treatment-free period should take into account the pharmacokinetic properties of the veterinary medicinal product used previously.
Administration routes and dosage
Oral use.
The recommended dose of cimicoxib is 2 mg/kg bodyweight, once daily. The following table is presented as an example of how the tablets and tablet parts could be used in order to reach the recommended dose.
Bodyweight kg | 8mg | 30mg | 80mg |
2 | ½ | | |
3 | 1 | | |
4 | 1 | | |
5 | | ⅓ | |
6 | 1 + ½ | | |
7-8 | 2 | | |
9-11 | 2+ ½ | | |
12 | 3 | | |
13-17 | | 1 | |
18-22 | | | ½ |
23-28 | | 1 + ⅔ | |
29-33 | | 2 | |
34-38 | | 2 + ⅓ | |
39-44 | | | 1 |
45-48 | | 3 | |
49-54 | | | 1 + ¼ |
55-68 | | | 1 + ½ |
The choice of the most suitable tablet type or tablet parts is left to the discretion of the veterinarian based on the circumstances in each case, without leading to important over- or underdosing.
Treatment duration:
∙ Management of peri-operative pain due to orthopaedic or soft tissue surgeries: one dose 2 hours prior to surgery, followed by 3 to 7 days of treatment, based on the judgment of the attending veterinarian.
∙ Relief of pain and inflammation associated with osteoarthritis: 6 months. For longer-term treatment, regular monitoring should be undertaken by the veterinarian.
The veterinary medicinal product can be administered with or without food. The tablets are flavoured, and studies (in healthy Beagle dogs) show they are likely to be taken voluntarily by most dogs.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal period
Not applicable.