Zolan 100 mg Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Nimesulide

Available from:

Virbac S.A.

ATC code:

QM01AX17

INN (International Name):

Nimesulide

Authorization status:

Expired

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SULIDENE 100 MG TABLET FOR DOGS
(ZOLAN 100 MG TABLET FOR DOGS, UK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE
Nimesulide
100 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.
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
-
The dog should be monitored for signs of gastrointestinal
disturbances.
-
Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there
may be a potential risk of
increased renal toxicity.
-
If side effects occur, treatment should be discontinued and the advice
of a veterinary surgeon
should be sought.
1
-
Concurrent use of potentially nephrotoxic drugs should be avoided.
-
As with other NSAIDs, use in aged animals may involve additional risk.
-
Do not exceed the stated dose or the duration of treatment.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINAY MEDICINAL PRODUCT TO
ANIMALS:
In case of accidental ingestion by a child, seek medical advice
immediately and show the package
insert or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Typical undesirable effects associated with NSAIDs are vomiting, soft
faeces/diarrhoea, blood in
faeces, reduced appetite and letha