Semintra 10 mg/ml oral solution for cats Species: Cats Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations Active ingredient: Telmisartan Product:Semintra 10 mg/ml oral solution for cats Product index: Semintra 10 mg/ml Presentation Oral solution. Clear, colourless to yellowish viscous solution. Uses Treatment of systemic hypertension in cats. Dosage and administration Oral use. The initial recommended dose is 2 mg telmisartan/kg body weight (0.2 ml/kg body weight). After 4 weeks, the dosage of telmisartan may be reduced in cats with systolic blood pressure (SBP) of less than 140 mmHg (in 0.5 mg/kg increments) at the discretion of the veterinarian. If the SBP increases over the course of the disease the daily dose may be increased again up to 2 mg/kg. The target SBP range is between 120 and 140 mmHg. If SBP is below the target or if there are concurrent signs of hypotension, please refer to 'Special Precautions for Use'. The dosing regimen for hypertensive cats with concomitant chronic kidney disease is as described above except that for these cats the recommended minimum effective dose is 1 mg/kg. The product is to be administered once daily directly into the mouth or with a small amount of food. Semintra is an oral solution and is well accepted by most cats. The solution should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a ml scale. After administration of the veterinary medicinal product close the bottle tightly with the cap, wash the measuring syringe with water and let it dry. To avoid contamination, use the provided syringe only to administer Semintra. Contra-indications, warnings, etc Contraindications Do not use during pregnancy or lactation. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 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. Special precautions for use Special precautions for use in animals 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 with severe kidney disease. The safety and efficacy of telmisartan in such 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). In cats with hypertension it is good clinical practice to regularly monitor blood pressure. 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 the package leaflet or the label to the physician. Avoid eye contact. In case of accidental eye contact, rinse eyes with water. Wash hands after use. Pregnant women should take special care to avoid contact with the product because substances acting on the RAAS, such as Angiotensin Receptor Blockers (ARBs) and ACE inhibitors (ACEis), have been found to affect the unborn child during pregnancy in humans. People with hypersensitivity to telmisartan or other sartans/ARBs should avoid contact with the veterinary medicinal product. Adverse reactions (frequency and seriousness) Mild and transient gastrointestinal signs such as vomiting and diarrhoea associated with product administration have been observed commonly in a clinical study. Elevated liver enzymes have been very rarely observed and values normalised within a few days following cessation of therapy. Effects observed at the recommended treatment dose included mild decreases in red blood cell counts. In a European clinical field study, adverse events categorised as renal disorder/insufficiency (includes cases of chronic renal failure, elevated creatinine and/or blood urea nitrogen) were recorded in 3.6% of telmisartan-treated cats and 1% of placebo-treated cats. 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). Use during pregnancy, lactation or lay The safety of Semintra has not been established in breeding, pregnant or lactating cats. Do not use during pregnancy and lactation. Interaction with other medicinal products and other forms of interaction During concomitant therapy with amlodipine at the recommended dose for the reduction of proteinuria associated with chronic kidney disease (CKD) in cats no clinical evidence of hypotension was observed. Very limited data are available regarding interactions in cats with hypertension between telmisartan and other medicinal products that lower blood pressure (such as amlodipine) or interfere with the RAAS (such as ARBs or ACEis). The combination of telmisartan with such agents may lead to additive hypotensive effects or may alter renal function. Overdose (symptoms, emergency procedures, antidotes), if necessary After administration of up to 2.5 times the initial recommended dose for 6 months to young adult healthy cats, adverse reactions observed were consistent with those mentioned above. Administration of the product at overdose (up to 2.5 times the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN). In the event that hypotension does occur, symptomatic treatment, e.g. fluid therapy, should be provided. Pharmaceutical precautions In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary products. Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 6 months. This veterinary medicinal product does not require any special storage conditions. For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Legal category Legal category: POM-V