ROFENIFLEX 20 MG TABLETS FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
CARPROFEN
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QM01AE91
Dosage:
20 Milligram
Pharmaceutical form:
Tablets
Therapeutic group:
N.S.A.I.D
Therapeutic area:
Canine
Authorization date:
2006-06-02
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rofeniflex 20 mg Tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Carprofen
20.0 mg/tablet
EXCIPIENTS
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
A plain round flat bevelled edge white tablet with a breakline on one side. The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduction of inflammation and pain caused by musculo-skeletal disorders and degenerative joint disease. As a follow
up to parenteral analgesia in the management of post-operative pain following soft tissue surgery.
4.3 CONTRAINDICATIONS
Do not use in cats.
Do not use in case of hypersensitivity to active substance or to any of the excipients.
Do not use in dogs suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal
ulceration or bleeding, or where there is evidence of a blood dyscrasia.
Refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Refer to Sections 4.3 and 4.5.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/08/2011_
_CRN 7010825_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use in dogs less than 6 weeks of age, or in aged dogs, may involve additional risk. If such a use cannot be avoided,
dogs may require careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as
there is a potential risk of increased renal toxicity.
Concurrent administration of potential nephrotoxic drugs should be avoided. NSAIDs can cause inhibition of
phagocytosis and
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