Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Telmisartan
Boehringer Ingelheim Vetmedica GmbH
QC09CA07
telmisartan
Cats
Agents acting on the renin-angiotensin system, Angiotensin II antagonists, plain
Reduction of proteinuria associated with chronic kidney disease (CKD).
Revision: 6
Authorised
2013-02-13
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: SEMINTRA 4 MG/ML ORAL SOLUTION FOR CATS 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 Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Semintra 4 mg/ml oral solution for cats Telmisartan 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One ml contains: Telmisartan 4 mg Benzalkonium chloride 0.1 mg Clear, colourless to yellowish viscous solution. 4. INDICATION(S) Reduction of proteinuria associated with chronic kidney disease (CKD) in cats. 5. CONTRAINDICATIONS Do not use during pregnancy or lactation. See section “Pregnancy and lactation”. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 6. ADVERSE REACTIONS The following mild and transient gastrointestinal signs have rarely been observed in a clinical study (in order of decreasing frequency): mild and intermittent regurgitation, vomiting, diarrhoea or soft faeces. Elevated liver enzymes have been very rarely observed and values normalised within a few days following cessation of therapy. Effects attributable to the pharmacological activity of the product observed at the recommended treatment dose included reductions in blood pressure and decreases in red blood cell counts. 27 The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). If you notice any side effects, even those not already listed in this package leaflet or you t Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Semintra 4 mg/ml oral solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Telmisartan 4 mg EXCIPIENTS: Benzalkonium chloride 0.1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear, colourless to yellowish viscous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Reduction of proteinuria associated with chronic kidney disease (CKD) in cats. 4.3 CONTRAINDICATIONS Do not use during pregnancy or lactation (see also section 4.7). 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. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The safety and efficacy of telmisartan has not been tested in cats under the age of 6 months. It is good clinical practice to monitor the blood pressure of cats receiving Semintra which are under anaesthesia. Due to the mode of action of the veterinary medicinal product, transient hypotension may occur. Symptomatic treatment, e.g. fluid therapy, should be provided in case of any clinical signs of hypotension. As known from substances acting on the Renin-Angiotensin-Aldosterone System (RAAS), a slight decrease in red blood cell count may occur. Red blood cell count should be monitored during therapy. Substances acting on the RAAS may lead to a reduction in glomerular filtration rate and worsening renal function in cats with severe kidney disease. The safety and efficacy of telmisartan in such 3 patients has not been investigated. When using this product in cats with severe kidney disease, it is advisable to monitor renal function (plasma creatinine concentration). Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental ingestion, seek medical advice immediately and show th Прочетете целия документ