Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
Torasemide anhydrous
Vétoquinol SA
QC03CA04
Torasemide
Dogs
Sulfonamides, plain, High-ceiling diuretics
For treatment of clinical signs, including oedema and effusion, related to congestive heart failure in dogs.
Revision: 2
Authorised
2015-07-31
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: UPCARD 0.75 MG TABLETS FOR DOGS UPCARD 3 MG TABLETS FOR DOGS UPCARD 7.5 MG TABLETS FOR DOGS UPCARD 18 MG TABLETS FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Vetoquinol SA Magny-Vernois 70200 Lure FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT UpCard 0.75 mg tablets for dogs UpCard 3 mg tablets for dogs UpCard 7.5 mg tablets for dogs UpCard 18 mg tablets for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each tablet contains: UpCard 0.75 mg tablets for dogs 0.75 mg of torasemide UpCard 3 mg tablets for dogs 3 mg of torasemide UpCard 7.5 mg tablets for dogs 7.5 mg of torasemide UpCard 18 mg tablets for dogs 18 mg of torasemide UpCard 0.75 mg tablets are oblong white to off-white tablets with 1 break-line on each side. The tablets can be divided into equal halves. UpCard 3 mg, 7.5 mg and 18 mg tablets are oblong white to off-white tablets with 3 break-lines on each side. The tablets can be divided into equal quarters. 4. INDICATION(S) For treatment of clinical signs, including oedema and effusion, related to congestive heart failure. 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 17 Do not use in cases of renal failure. Do not use in cases of severe dehydration, hypovolaemia or hypotension. Do not use concomitantly with other loop diuretics. 6. ADVERSE REACTIONS Increase in renal blood parameters and renal insufficiency are very commonly observed during treatment. As a result of the diuretic action of torasemide, haemoconcentration and, very commonly, polyuria and/or polydipsia are observed. In case of prolonged treatment, electrolyte deficiency (including hypokalaemia, hypochloraemia, hypomagnesaemia) and dehydration may occur. Gastrointestinal signs which include emesis, reduced or absent faeces Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UpCard 0.75 mg tablets for dogs UpCard 3 mg tablets for dogs UpCard 7.5 mg tablets for dogs UpCard 18 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: UpCard 0.75 mg 0.75 mg of torasemide UpCard 3 mg 3 mg of torasemide UpCard 7.5 mg 7.5 mg of torasemide UpCard 18 mg 18 mg of torasemide For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. UpCard 0.75 mg tablets: oblong white to off-white tablets with 1 break-line on each side. The tablets can be divided into equal halves. UpCard 3 mg, 7.5 mg and 18 mg tablets: oblong white to off-white tablets with 3 break-lines on each side. The tablets can be divided into equal quarters. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment of clinical signs, including oedema and effusion, related to congestive heart failure. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in cases of renal failure. Do not use in cases of severe dehydration, hypovolaemia or hypotension. Do not use concomitantly with other loop diuretics. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals In dogs presenting in acute crisis with pulmonary oedema, pleural effusion and/or ascites requiring emergency treatment, the use of injectable drugs should be considered first before commencing oral diuretic therapy. Renal function, hydration status and serum electrolytes status should be monitored: - at treatment initiation - from 24 hours to 48 hours after treatment initiation - from 24 hours to 48 hours after dose change - in case of adverse events. While the animal is on treatment, these parameters should be monitored at very regular intervals according to the benefit-risk assessment performed by the responsible veterinarian Đọc toàn bộ tài liệu