Country: United Kingdom
Bahasa: Inggeris
Sumber: VMD (Veterinary Medicines Directorate)
Propentofylline
WDT-Wirtschaftsgenossenschaft deutscher Tieraerzte eG
QC04AD90
Propentofylline
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular
Authorized
2012-05-01
Revised: January 2023 AN: 02735/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vitofyllin 100 mg film-coated tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: ACTIVE SUBSTANCE: Propentofylline 100.00 mg/tablet EXCIPIENTS: Ferric Oxide, yellow, (E 172) 0.150 mg/tablet Titanium Dioxide, (E171) 0.430 mg/tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Yellow, round convex tablets with cross breakline on one side and imprinting "100" on the other side. The tablet can be divided into 2 or 4 equal parts. 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 5 kg. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: January 2023 AN: 02735/2022 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE i) 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 ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Care should be taken to avoid accidental ingestion. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use. Special precautions for the protection of the environment: Not applicable. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Dogs: Rare (1 to 10 animals / 10,000 animals treated) Allergic skin reactions*, vomit Baca dokumen lengkap