Država: Velika Britanija
Jezik: engleski
Izvor: VMD (Veterinary Medicines Directorate)
Telmisartan
Alfasan Nederland B.V.
QC09CA07
Telmisartan
Oral solution
POM-V - Prescription Only Medicine – Veterinarian
Cats
Miscellaneous
Authorized
2023-07-21
Issued: July 2023 AN: 02993/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Telmitraxx 4 mg/ml oral solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Telmisartan 4 mg EXCIPIENTS: Benzalkonium chloride 0.1 mg Disodium edetate 1.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear and colourless to yellow solution practically free from particles. 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). 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 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. Issued: July 2023 AN: 02993/2021 Page 2 of 6 It is good clinical practice to monitor the blood pressure of cats receiving telmisartan 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 patients has not been investigated. When using this veterinary medicinal product in cats with severe kidney disease, it is advisable to monitor renal function (plasma creatinine concentration). ii). Special precautions to be take Pročitajte cijeli dokument