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Issued: November 2011
AN: 00468/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rimifin 20 mg Tablets for dogs (DE, DK & NL)
Eurofen 20mg Tablets for Dogs (BE, IE & UK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains :
ACTIVE INGREDIENT
Carprofen
20.0 mg
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
In the dog:
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.
Page 1 of 7
Issued: November 2011
AN: 00468/2010
4.3
CONTRA-INDICATIONS
Do not use in cats.
Do not use in pregnant or lactating bitches.
Do not use in pups less than 4 months of age.
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Refer to Sections 4.3 and 4.5
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use 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 hence in the treatment
of
inflammatory conditions associated with bacterial
infection, appropriate
concurrent antimicrobial therapy should be instigated.
Do not administer other NSAIDs concurrently or within 24 hours of each
other. Some NSAIDs may be
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