Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Tolfenamic acid
Vetoquinol Ireland Limited
QM01AG02
Tolfenamic acid
4 percent weight/volume
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
tolfenamic acid
N.S.A.I.D.
Authorised
1993-08-12
_ _ _[Version 8.1, 01/2017] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tolfedine 4% w/v Solution for Injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Tolfenamic acid 40 mg EXCIPIENTS Benzyl alcohol 10.4 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sterile solution for injection. A clear colourless to slightly yellow sterile aqueous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs, Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES IN DOGS : inflammatory and painful post-operative syndromes. IN CATS : adjuvant treatment of upper respiratory disease in association with antimicrobial therapy. 4.3 CONTRAINDICATIONS Tolfenamic acid is contraindicated in case of cardiac disease. Do not use in animals with impaired hepatic function or acute renal insufficiency. Tolfenamic acid is contraindicated in case of ulceration or digestive bleeding, in case of blood dyscrasia or hypersensivitivy to tolfenamid acid. Do not inject intramuscularly in cats. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES NSAIDS can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infections. Appropriate concurrent antimicrobial therapy should be instigated. The use of insulin-type needle/syringe is advisable particularly in low-weight animals to ensure an accurate dose. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Use in animals less than 6 weeks of age, or in aged animals, may involve additional risk. If such a use cannot be avoided, animals may require a reduced dosage and careful clinical management is essential. Reduced metabolism and excretion in these animals should be considered. Avoid use in any dehydrated, hypovolemic or hypotensive animal, as there is a potential risk of increased renal toxicity. Concurrent administration of potential nephrotoxic drugs should be avoided. It is preferable that the product Διαβάστε το πλήρες έγγραφο