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_[Version 7.1, 10/2006] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
SULIDENE 50 mg RENEWAL Final SPC March 2007
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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SULIDENE 50 MG TABLET FOR DOGS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE
Nimesulide
50 mg
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Round light yellow divisible tablet
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
Reduction of inflammation and relief of pain associated with musculo-skeletal disorders.
4.3
CONTRAINDICATIONS
Do not use in animals suffering from gastrointestinal ulceration or bleeding.
Do not use where there is hypersensitivity to the product.
Do not use in animals suffering from cardiac, hepatic or renal impairment.
Do not use where there is evidence of a blood dyscrasia.
Do not use in puppies younger than 4 months and in dogs under 3,5 kg.
Do not use in cats.
And see section 4.7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
A dark yellow discoloration of the serum and urine may be observed in treated animals.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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The dog should be monitored for signs of gastrointestinal disturbances.
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Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of
increased renal toxicity.
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If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon
should be sought.
SULIDEN
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