Trocoxil 6 mg Chewable Tablets for Dogs

Do not administer other NSAIDs or glucocorticoids concurrently or within 1 month of
the last administration of Trocoxil.

i. Special precautions for use in animals
Mavacoxib exhibits an extended plasma half life (up to > 80 days, see section 5.2)
due to its low rate of elimination. This corresponds to a duration of effect of 1-2
months after administration of the second dose (and following doses). Care should
be taken to avoid treatment of animals that might not tolerate prolonged NSAID
exposure. A maximum treatment administration of 6.5 months continuous therapy is
recommended so as to manage plasma levels of mavacoxib in animals which
exhibit reduced elimination
Animals should undergo a thorough clinical examination before commencing
treatment with Trocoxil and appropriate laboratory tests to monitor haematology
and clinical chemistry are recommended. Animals with evidence of impaired renal
or hepatic function, or with evidence of a protein or blood losing enteropathy are not
suitable for treatment with Trocoxil. It is recommended to repeat the clinical
examination one month after commencing treatment with Trocoxil and prior to
administration of the third dose with additional monitoring of clinical pathology as
appropriate during treatment.
Mavacoxib is excreted via bile and in dogs with hepatic disorders reduced
elimination and thus excessive accumulation could occur. For this reason, dogs
with hepatic disorders should not be treated.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a
potential risk of increased renal toxicity. Concurrent administration of potentially
nephrotoxic medicinal products should be avoided.
Ensure appropriate hydration and haemodynamic status when animals receiving
Trocoxil undergo anaesthesia and/or surgical procedures or develop conditions
which may result in dehydration or compromised haemodynamic status. The key
aim of intervention is to maintain renal perfusion. Patients with underlying renal
disease may experience exacerbation or decompensation of their renal disease
while on NSAID therapy. (See also section 4.6).

Issued: October 2023
AN: 01444/2022
ii. Special precautions to be taken by the person administering the veterinary
medicinal product to animals
In case of accidental self-ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
Ingestion of the product may be harmful for children, and prolonged
pharmacological effects leading to e.g. gastrointestinal disorders may be observed.
To avoid accidental ingestion, administer the tablet to the dog immediately after
removal from the blister packaging.
People with known hypersensitivity to NSAIDs should avoid contact with the
veterinary medicinal product.
Do not eat, drink, or smoke when handling the product. Wash hands after handling
the product.
Special precautions for the protection of the environment:
Not applicable.