Semintra
telmisartan
Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein GERMANY
Semintra 4 mg/ml oral solution for cats Telmisartan
One ml contains:
Telmisartan 4 mg
Benzalkonium chloride 0.1 mg
Clear, colourless to yellowish viscous solution.
Reduction of proteinuria associated with chronic kidney disease (CKD) in cats.
Do not use during pregnancy or lactation. See section “Pregnancy and lactation”.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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.
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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Cats
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.
Push down and turn cap to open the bottle. Attach the dosing syringe to the plug-in adapter of the bottle by gently pushing.
Turn the bottle/syringe upside down. Pull the plunger out until the end of the plunger corresponds to your cat´s body weight in kilograms.
Separate the dosing syringe from the bottle.
Push the plunger to empty the contents of the syringe directly into the mouth of the cat
…
… or onto a small amount of food.
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.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Shelf life after first opening of the bottle: 6 months.
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 (low blood pressure) 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 product in cats with severe kidney disease, it is advisable to monitor renal function (plasma creatinine concentration).
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.
Pregnancy and lactation
The safety of Semintra has not been established in breeding, pregnant or lactating cats. Do not use during pregnancy and lactation. See section “Contraindications”.
Interaction with other medicinal products and other forms of interaction
During concomitant therapy with amlodipine at the recommended dose no clinical evidence of hypotension was observed.
No drug-drug interactions are known from 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.
Overdose (symptoms, emergency procedures, antidotes)
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 “Adverse reactions”.
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; nitrogen containing waste products in the blood).
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary products.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Pack sizes of one plastic bottle filled with 30 ml or one plastic bottle filled with 100 ml. 1 measuring syringe.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein GERMANY
Semintra 10 mg/ml oral solution for cats Telmisartan
One ml contains:
Telmisartan 10 mg
Benzalkonium chloride 0.1 mg
Clear, colourless to yellowish viscous solution.
Treatment of systemic hypertension in cats.
Do not use during pregnancy or lactation. See section “Pregnancy and lactation”.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Cats
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 the “Special warnings” section.
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.
Push down and turn cap to open the bottle. Attach the dosing syringe to the plug-in adapter of the bottle by gently pushing.
Turn the bottle/syringe upside down. Pull the plunger out until the end of the plunger corresponds to the amount needed in ml. Separate the dosing syringe from the bottle.
Push the plunger to empty the contents of the syringe directly into the mouth of the cat
…
… or onto a small amount of food.
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.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Shelf life after first opening of the bottle: 6 months.
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.
The safety and efficacy of telmisartan for the management of systemic hypertension above 200 mmHg has not been investigated.
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.
Pregnancy and lactation
The safety of Semintra has not been established in breeding, pregnant or lactating cats. Do not use during pregnancy and lactation. See section “Contraindications”.
Interactions 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 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)
After administration of up to 2.5 times the initial recommended dose for 6 months to young adult healthy cats, adverse reactions were consistent with those mentioned in section “Adverse reactions”.
Administration of the product at overdose (up to 2.5 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 (low blood pressure) does occur, symptomatic treatment, e.g. fluid therapy, should be provided.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary products.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Pack size of one plastic bottle filled with 35 ml and one measuring syringe.