TOLFEDINE 6 MG TABLETS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

TOLFENAMIC ACID

Available from:

Vetoquinol Ireland Limited

ATC code:

QM01AG02

INN (International Name):

TOLFENAMIC ACID

Dosage:

6 mg/tablet

Pharmaceutical form:

Tablets

Prescription type:

POM

Therapeutic group:

Canine, Feline

Therapeutic area:

Tolfenamic acid

Therapeutic indications:

N.S.A.I.D

Authorization status:

Authorised

Authorization date:

1993-08-12

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tolfedine 6 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tablet contains:
Active Substance:
Tolfenamic Acid
6 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, Cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cat: Febrile syndromes (abscess, fever of unknown origin)
Dog: Acute flare ups of chronic locomotor disease
4.3 CONTRAINDICATIONS
Concurrent administration with other steroidal or non-steroidal anti-inflammatory drugs.
Do not use in animals with suspected gastro-duodenal ulceration.
Do not use in animals with impaired renal or hepatic function.
Do not use in pregnant animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 14/08/2015_
_CRN 7021600_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Do not exceed the stated dose or duration of treatment.
Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided,
careful clinical management is essential. Reduced metabolism and excretion in these animals should be considered.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal toxicity.
It is preferable that TOLFEDINE is not administered to animals undergoing general anaesthesia until fully recovered.
Where there is appearance of bloody or black faeces, a veterinary surgeon should be contacted for advice and the
possibility of stopping treatment should be considered.
SPECIAL PRECAUTIONS TO BE TAK
                                
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