Šalis: Vokietija
kalba: anglų
Šaltinis: HMA (Heads of Medicines Agencies)
propentofylline 50 mg
Animalcare Limited
QC04A
Tablet
PERIPHERAL VASODILATORS
Dogs
2012-02-22
Issued: May 2012 AN: 02114/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vitofyllin 50 mg film-coated tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Propentofylline 50.00 mg/tablet EXCIPIENTS: Ferric Oxide, yellow, (E 172) 0.075 mg/tablet Titanium Dioxide, (E171) 0.215 mg/tablet For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Yellow, round, convex tablets with cross-snap tab on one and impr inting “50” on the other side. The tablet can be divided into equal halves and quarters. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the improvement of peripheral and cerebral vascular blood circulation. For improvement in dullness, lethargy and overall demeanour in dogs_._ 4.3 CONTRAINDICATIONS Refer to section 4.7 Do not use in dogs weighing less than 2.5 kg. Do not use in cases of hypersensitivity to the active substance and/or to any of the other ingredients of the product. 4.4 SPECIAL WARNINGS None. Issued: May 2012 AN: 02114/2010 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Specific diseases (e.g. kidney disease) should be treated accordingly. Consideration should be given to rationalising the medication of dogs already receiving treatment for congestive heart failure or bronchial disease. In the case of renal failure, the dose should be reduced. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Perskaitykite visą dokumentą