Ország: Egyesült Királyság
Nyelv: angol
Forrás: VMD (Veterinary Medicines Directorate)
Telmisartan
Boehringer Ingelheim Vetmedica Gmbh
QC09CA07
Telmisartan
Oral suspension
POM-V - Prescription Only Medicine – Veterinarian
Cats
Miscellaneous
Authorized
2018-05-08
Issued: July 2023 AN:01478/2022 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Semintra 10 mg/ml oral solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Telmisartan 10 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. Treatment of systemic hypertension 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. Issued: July 2023 AN:01478/2022 Page 2 of 8 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The safety and efficacy of telmisartan for the management of systemic hypertension above 200 mmHg has not been investigated. 4.5 SPECIAL PRECAUTIONS FOR USE i). 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 the veterinary medicinal product 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. The dosage of telmisartan should be reduced if systolic blood pressure (SBP) is consistently lower than 120 mmHg or if there are concurrent 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 Olvassa el a teljes dokumentumot