Cimalgex 8mg Chewable Tablets for Dogs (pack of 32)
Cimalgex 8mg Chewable Tablets for Dogs (pack of 32)
|Prescription Type||POM-V (Written prescription required)|
What is Cimalgex and who is it for?
Cimalgex is a chewable tablet for dogs that is used for the management of pain and inflammation associated with osteoarthritis. It is also used for the management of peri-operative pain due to orthopaedic or soft tissue surgery in dogs.
This is a Prescription only medicine (POM-V).
Cimalgex is only available with a prescription from your veterinary surgeon.
To check the most up to date information about this product, please read its Summary of Product Characteristics (SPC). It can be viewed here.
What is the active ingredient in Cimalgex?
Cimicoxib is a non-steroidal anti-inflammatory medicinal product belonging to the coxib group and acting by selective inhibition of the enzyme cyclo-oxygenase 2. The cyclo-oxygenase enzyme (COX) is present in two isoforms. COX-1 is usually a constitutive enzyme expressed in tissues, which synthesize products responsible for normal physiologic functions (e.g. in the gastro-intestinal tract and kidneys). COX-2 on the other hand, is mainly inducible and synthesized by macrophages and inflammatory cells after stimulation by cytokines and other mediators of inflammation. COX-2 is involved in the production of mediators, including PGE2, that induce pain, exudation, inflammation and fever.
In an in vivo inflammatory acute pain model, it was shown that the simulated effect of cimicoxib lasted for approximately 10-14 hours.
After oral administration in dogs at the recommended dose of 2 mg/kg without food, cimicoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 2.25 (± 1.24) hours. The peak concentration (Cmax) is 0.3918 (± 0.09021) µg/ml, area under the curve (AUC) is 1.676 (± 0.4735) µg.hr/ml, and oral bioavailability is 44.53 (± 10.26) percent.
The oral administration of cimicoxib with food did not significantly influence the bioavailability but decreased significantly the observed Tmax.
Metabolism of cimicoxib is extensive. The major metabolite, demethylated cimicoxib is mainly eliminated in faeces by the biliary route and, to a lesser extent, in urine. The other metabolite, glucuronide conjugate of the demethylated cimicoxib, is eliminated in urine. The elimination half-life (t1/2) is 1.38 (± 0.24) hours. The metabolising enzymes have not been fully investigated and slower metabolism (up to four-fold increased exposure) has been noted in some individuals.
What is in Cimalgex?
Oblong, white to pale brown, chewable tablets with 1 break-line on both sides. The tablets can be divided into equal halves.
One tablet contains the following active substances:
Cimicoxib 8 mg
How do I use Cimalgex?
Cimalgex is a prescription product and must be applied according to the instructions of your veterinary surgeon.
Please read the product leaflet thoroughly before applying to your pet.
Marketing Authorisation Holder
Vetoquinol UK Limited
Pury Hill Business Park
Marketing Authorisation Number
EU/2/10/119/001 - EU/2/10/119/012
Is there any further advice I should know about Cimalgex?
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 precautions 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 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 (symptoms, emergency procedures, antidotes), if necessary.
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.
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