Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Telmisartan
Alfasan Nederland B.V
QC09CA07
Telmisartan
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
telmisartan
2023-08-04
1 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: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t Benzalkonium chloride solution 0.1 mg Maltitol Hydroxyethylcellulose Disodium edetate 1.0 mg Water, purified Sodium hydroxide Hydrochloric acid, dilute Clear and colourless to yellow solution practically free from particles 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cats 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Reduction of proteinuria associated with chronic kidney disease (CKD). 3.3 CONTRAINDICATIONS Do not use during pregnancy or lactation (see also section 3.7). Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS None. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: 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 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. 2 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 creatini Lue koko asiakirja