CIMALGEX 80 mg CHEWABLE TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CIMICOXIB

Available from:

VETOQUINOL AUSTRALIA PTY LTD

Pharmaceutical form:

ORAL BOLUS, CHEWABLE

Composition:

CIMICOXIB ANTI-INFLAMMATORY Active 80.0 mg/Tb

Units in package:

144 tablets; 32 tablets; 8 tablets

Class:

VM - Veterinary Medicine

Therapeutic area:

ANALGESIC+MUSCULOSKELETAL

Product summary:

Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANALGESIC, MUSCOSKELETAL DISCOMFORT, MUSCULOSKELETAL CONDITIONS, ORTHOPAEDIC - INFLAMATION]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Cimalgex 80 mg Chewable Tablets for Dogs
84039/109543
Product Name:
APVMA Approval No:
Label Name:
Cimalgex 80 mg Chewable Tablets for Dogs
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
Constituent
Statements:
Each tablet contains 80 mg Cimicoxib
Claims:
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.
Net Contents:
8 tablets
32 tablets
144 tablets
Directions for Use:
Restraints:
Contraindications:
This product should not be used in dogs suffering from
gastrointestinal disorders or
haemorrhagic disorders.
This product should not be used in dogs exhibiting previous
hypersensitivity to cimicoxib.
This product is contraindicated for use in any animals which are
dehydrated, hypovolaemic
or hypotensive, as it may increase the risk of renal toxicity.
Precautions:
The safety of CIMALGEX in dogs less than 10 weeks of age or in
breeding, pregnant or
lactating animals has not been established. Although no data are
available in dogs,
studies with laboratory animals have shown effects on fertility and
foetal development. RLP APPROVED
Since the safety of cimicoxib has not been adequately demonstrated in
young animals,
careful monitoring is advised during the treatment of young dogs aged
less than 6 months.
Avoid administration concurrently with corticosteroids or other
non-steroidal anti-
inflammatory drugs (NSAIDs). Pre-treatment with other
anti-inflammatory substances
may result in additional or increased adverse effects. A
treatment-free period, taking into
account the pharmacokinetic properties of such substances, should be
observed before
initiation of treatment with CIMALGEX CHEWABLE TABLETS FOR DOGS.
Use in animals suffering from impaired cardiac or hepatic function may
involve additional
risk. If such use cannot be avoided, these animals require careful
veterinary monitoring.
Use CIMALGEX CHEWABLE TAB