País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Tolfenamic acid
Vetoquinol Ireland Limited
QM01AG02
Tolfenamic acid
6 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Canine, Feline
tolfenamic acid
N.S.A.I.D.
Authorised
1993-08-12
Health Products Regulatory Authority 06 November 2018 CRN008PTT Page 1 of 5 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. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Health Products Regulatory Authority 06 November 2018 CRN008PTT Page 2 of 5 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 TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS None. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Diarrhoea and vomiting may occur during treatment. Where either persists, treatment should be discontinued. 4.7 USE DURING PREGNANCY, LACTATION O Leia o documento completo