Semintra (telmisartan) – Summary of product characteristics - QC09CA07

Updated on site: 09-Feb-2018

Medication name: Semintra
ATC: QC09CA07
Substance: telmisartan
Manufacturer: Boehringer Ingelheim Vetmedica GmbH

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Semintra 4 mg/ml oral solution for cats

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains

 

Active substance

 

Telmisartan

4 mg

Excipient:

Benzalkonium chloride 0.1 mg

For the full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Oral solution.

Clear, colourless to yellowish viscous solution.

4.CLINICAL PARTICULARS

4.1Target species

Cats

4.2Indications for use, specifying the target species

Reduction of proteinuria associated with chronic kidney disease (CKD) in cats.

4.3Contraindications

Do not use during pregnancy or lactation (see also section 4.7).

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4Special warnings for each target species

None.

4.5Special precautions for use

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.

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.

4.6Adverse reactions (frequency and seriousness)

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 displaying adverse reactions during the course of one treatment)

-common (more than 1 but less than 10 animals in 100 animals)

-uncommon (more than 1 but less than 10 animals in 1,000 animals)

-rare (more than 1 but less than 10 animals in 10,000 animals)

-very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7Use during pregnancy, lactation or lay

The safety of Semintra has not been established in breeding, pregnant or lactating cats. Do not use during pregancy or laction (see section 4.3).

4.8Interaction 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.

4.9Amounts to be administered and administration route

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

After administration of up to 5-fold of the recommended dose for 6 months, no adverse reactions were observed other than those mentioned in section 4.6.

Administration of the product at overdose (up to 5-fold 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). These effects are unlikely to be observed under clinical conditions.

However, in the event that transient hypotension does occur, symptomatic treatment, e.g. fluid therapy, should be provided.

4.11 Withdrawal period

Not applicable.

5.PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: angiotensin II antagonists, plain, telmisartan

ATCvet code: QC09CA07

5.1Pharmacodynamic 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.

Hypokalemia is associated with CKD, however telmisartan does not affect potassium excretion, as shown in the clinical field trial in cats.

5.2Pharmacokinetic 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 with faeces mainly as unchanged compound.

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Benzalkonium chloride

Hydroxyethylcellulose

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Maltitol

Purified water

6.2Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary products.

6.3Shelf life

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

6.4Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5Nature and composition of immediate packaging

Cardboard box containing one 45 ml HDPE bottle filled with 30 ml closed with a LDPE plug-in adapter and a tamper-proof child resistant closure and a measuring syringe.

Cardboard box containing one 124 ml HDPE bottle filled with 100 ml closed with a LDPE plug-in adapter and a tamper-proof child resistant closure and a measuring syringe.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7.MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/12/146/001

EU/2/12/146/002

9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13.02.2013

10.DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

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