Cimalgex 30mg chewable tablets for dogs

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Cimicoxib

Available from:

Gladron Chemicals Sdn Bhd

INN (International Name):

Cimicoxib

Units in package:

144 Tablets; 32 Tablets

Manufactured by:

Vetoquinol SA

Patient Information leaflet

Not Applicable

Summary of Product characteristics

CIMALGEX 8 MG CHEWABLE TABLETS FOR DOGS
CIMALGEX 30 MG CHEWABLE TABLETS FOR DOGS
CIMALGEX 80 MG CHEWABLE TABLETS FOR DOGS
CIMICOXIB
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each tablet contains:
Cimicoxib 8 mg
Cimicoxib 30 mg
Cimicoxib 80 mg
Cimalgex 8 mg tablets: oblong tablets (10x4mm), white to beige, brown
spotted, with one break-line on
both sides.
Cimalgex 30 mg tablets: Oblong tablets (15x6.5mm), white to beige,
brown spotted, with 2 parallel breaking
lines on both sides.
Cimalgex 80 mg tablets: Oblong tablets (21.5x8.5mm), white to beige,
brown spotted, with 3 parallel
breaking lines on both sides.
PHARMACODYNAMICS
Cimicoxib is a non-narcotic, non-steroidal anti-inflammatory drug
(NSAID). It selectively inhibits the
cyclooxygenase 2 enzyme (COX-2), which is responsible for pain,
inflammation or fever.
The cyclooxygenase 1 enzyme (COX-1) which has protective functions,
for example, in the digestive tract
and kidneys, is not inhibited by cimicoxib.
PHARMACOKINETICS
After oral administration in dogs at the recommended doses, cimicoxib
is rapidly absorbed. 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 demethy-
lated cimicoxib, is eliminated in urine.
In an artificially induced pain model in dogs it was shown that the
pain and inflammation reducing effects
of cimicoxib lasted for approximately 10-14 hours.
DISPOSAL OF CONTAINERS
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer
required. These measures should help
to protect the environment.
DIRECTION FOR USE
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.
DOSAGE AND ADMINISTRATION
Oral use.
The recommended dose of cimicoxib is 2 mg per kg bodyweight, once
daily.
The fo