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Date: Sunday, May 29, 2022 11:29

Release 4.140
Semintra 4 mg/ml oral solution for cats
Species: Cats
Therapeutic indication: Pharmaceuticals: Renal preparations
Active ingredient: Telmisartan
Product:Semintra 4 mg/ml oral solution for cats
Product index: Semintra 4 mg/ml
Clear, colourless to yellowish viscous oral solution. 1 ml contains 4 mg of telmisartan as active substance and 0.1 mg benzalkonium chloride as excipient.
Reduction of proteinuria associated with chronic kidney disease (CKD) in cats.
Dosage and administration
Oral use.
The recommended dose is 1 mg telmisartan/kg body weight (0.25 ml/kg body weight). 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 kg-body weight 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
Do not use during pregnancy or lactation. The safety of Semintra has not been established in breeding, pregnant or lactating cats.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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.
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.
During concomitant therapy with amlodipine at the recommended dose no clinical evidence of hypotension was observed.
No drug-drug interactions are known from the available data in cats with CKD for the use of telmisartan and other medicinal products that interfere with RAAS (such as ARBs or ACEis). The combination of agents targeting the RAAS may alter renal function.
After administration of up to 5 times the recommended dose for 6 months to young adult healthy cats, adverse reactions observed were consistent with those mentioned in section 4.6.
Administration of the product at overdose (3 to 5 times of 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.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary products.
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 (ACEi), 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.
Pharmaceutical precautions
Shelf life of the veterinary medicinal product as packaged for sale (30 ml or 100 ml): 3 years.
Shelf life after first opening the immediate packaging: 6 months.
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
Packaging quantities
One HDPE bottle filled with 30 ml or 100 ml.
Each bottle is closed with an LDPE plug-in adapter and a tamper-proof child resistant closure.
Pack size of one bottle and one measuring syringe.
Not all pack sizes may be marketed.
Further information
Pharmacodynamic properties
Telmisartan is an orally active and specific angiotensin II receptor (type AT1) antagonist which causes a dose dependent decrease in mean arterial blood pressure in mammalian species including the cat. In a clinical trial in cats with chronic kidney disease, a reduction in proteinuria was seen within the first 7 days after the start of treatment.
Telmisartan displaces angiotensin II from its binding site at the AT1 receptor subtype. Telmisartan selectively binds to the AT1 receptor and does not show affinity for other receptors, including AT2 or other less characterised AT receptors. Stimulation of the AT1 receptor is responsible for pathologic effects of angiotensin II in the kidney and other organs associated with angiotensin II such as vasoconstriction, retention of sodium and water, increased aldosterone synthesis and organ remodeling. Effects associated with stimulation of the AT2 receptor such as vasodilatation, natriuresis and inhibition of inappropriate cell growth are not suppressed. The receptor binding is long lasting due to the slow dissociation of telmisartan from the AT1 receptor binding site. Telmisartan does not exhibit any partial agonist activity at the type AT1 receptor.
Hypokalaemia is associated with CKD, however telmisartan does not affect potassium excretion, as shown in the clinical field trial in cats.
Pharmacokinetic properties
Absorption Following oral administration of 1 mg/kg body weight telmisartan to cats, plasma-concentration-time curves of the parent compound are characterised by rapid absorption, with maximum plasma concentrations (Cmax) achieved after 0.5 hours (tmax). For both, Cmax-values, and AUC-values, a dose proportional increase over the dose range from 0.5 mg/kg to 3 mg/kg was observed. As determined by AUC, food consumption does not affect the overall extent of absorption of telmisartan. Telmisartan is highly lipophilic and has rapid membrane permeability kinetics, which facilitates easy distribution into tissue. No significant gender effect was seen. No clinically relevant accumulation was observed following multiple dose administration once daily for 21 days. The absolute bioavailability after oral administration was found to be 33 %.
Distribution In vitro studies in human, dog, mouse and rat plasma showed a high plasma protein binding (> 99.5 %), mainly to albumin and α-1-acid glycoprotein.
Metabolism Telmisartan is metabolised by conjugation to the glucuronide of the parent compound. No pharmacological activity has been shown for the conjugate. From in vitro and ex vivo studies with feline liver microsomes it can be concluded that telmisartan is effectively glucuronidated in the cat. The glucuronidation resulted in the formation of the 1-O-acylglucuronide metabolite of telmisartan.
Elimination The terminal elimination half life (t 1/2) ranged from 7.3 hours to 8.6 hours, with mean value 7.7 hours. After oral administration, telmisartan is almost exclusively excreted in the faeces mainly as unchanged compound.
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim/Rhein, Germany
Marketing Authorisation Number
UK(GB): Vm 04491/5059
UK(NI): EU/2/12/146/001 - 30 ml
UK(NI): EU/2/12/146/002 - 100 ml
Significant changes
GTIN description:Semintra 4 mg/ml oral solution for cats
GTIN:5012917030167 - 30 ml, 5012917030198 - 100 ml