Semintra (telmisartan) – Package leaflet - QC09CA07

Updated on site: 09-Feb-2018

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

PACKAGE LEAFLET

Semintra 4 mg/ml oral solution for cats

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein GERMANY

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Semintra 4 mg/ml oral solution for cats

Telmisartan

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

One ml contains:

 

Telmisartan

4 mg

Benzalkonium chloride

0.1 mg

Clear, colourless to yellowish viscous solution.

4.INDICATION(S)

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

5.CONTRAINDICATIONS

Do not use during pregnancy or lactation. See section “Pregnancy or lactation”.

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

6.ADVERSE REACTIONS

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 may occur.

Elevated liver enzymes have been very rarely observed and values normalized 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).

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Cats

8.DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF 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.

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

… or onto a small amount of food.

the syringe directly into the mouth of the cat

 

 

9.ADVICE ON CORRECT ADMINISTRATION

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.

10.WITHDRAWAL PERIOD

Not applicable.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions Shelf life after first opening of the bottle: 6 months.

Do not use after the expiry date stated on the carton and the bottle after EXP.

12.SPECIAL WARNING(S)

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.

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.

Pregnancy or lactation

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

Overdose (symptoms, emergency procedures, antidotes)

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 "Adverse reactions".

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; nitrogen containing waste products in the blood). These effects are unlikely to be observed under clinical conditions.

However, in the event that transient 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.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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.

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

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

15.OTHER INFORMATION

45 ml plastic bottle filled with 30 ml or. 124 ml plastic bottle filled with 100 ml. 1 measuring syringe.

Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

Luxembourg/Luxemburg

SCS Boehringer Ingelheim Comm. V

SCS Boehringer Ingelheim Comm. V

Avenue Ariane/Arianelaan 16

Avenue Ariane/Arianelaan 16

1200 Bruxelles

1200 Bruxelles

Tel. : +32 (0) 2 773 33 11

BELGIQUE

 

Tel. : +32 2 773 33 11

Република България

Magyarország

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim RCV GmbH & Co KG

Animal Health

Magyarországi Fióktelepe

Dr. Boehringer-Gasse 5-11

Lechner Ödön fasor 6.

1121 Виена

1095 Budapest

АВСТРИЯ

Tel: +36 1 299 8900

Tel. +43 1 80 105 0

 

Česká republika

Malta

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim Animal Health GmbH

Animal Health

Binger Str. 173

Dr. Boehringer-Gasse 5-11

55216 Ingelheim/Rhein

1121 Vídeň

IL-ĠERMANJA

RAKOUSKO

Tel. +49 6132 77 6720

Tel. +43 1 80 105 0

 

Danmark

Boehringer Ingelheim Danmark A/S

Strødamvej 52

2100 København Ø

Tlf: +45-39 15 88 88

Deutschland

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55216 Ingelheim/Rhein

Tel. +49-(0) 6132 77 92 220

Eesti

Boehringer Ingelheim RCV GmbH & Co KG

Animal Health

Dr. Boehringer-Gasse 5-11

1121 Viin

AUSTRIA

Tel. +43 1 80 105 0

Ελλάδα

Boehringer Ingelheim Animal Health GmbH Binger Str. 173,

55216 Ingelheim/Rhein

ΓΕΡΜΑΝΊΑ

Tel. +49 6132 77 6720

España

Boehringer Ingelheim España, S.A. Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona) Tel: +34 93 404 51 00

France

Boehringer Ingelheim France Division Santé Animale

12, rue André Huet 51100 Reims

Tél. : +33 03 26 50 47 50 Télécopie : +33 03 26 50 47 43

infoveto@rei.boehringer-ingelheim.com

Ireland

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell, Berkshire, RG12 8YS,

UNITED KINGDOM

Tel: +44 1344 424 600

Nederland

Boehringer Ingelheim bv Comeniusstraat 6

1817 MS Alkmaar

Tel: +31 (0) 72 566 2411

Norge

Boehringer Ingelheim Vetmedica A/S

Billingstadsletta 30

Postboks 155

1376 Billingstad

Tlf: +47-66 85 05 70

Österreich

Boehringer Ingelheim RCV GmbH & Co KG Animal Health

Dr. Boehringer-Gasse 5-11 1121 Wien

Tel. +43- (0) 1 80 105 0

Polska

Boehringer Ingelheim Sp.z o.o. ul.Franciszka Klimczaka 1, 02-797 Warszawa

Tel: +48- (0) 22 – 699 0 699

Portugal

Vetlima - Sociedade Distribuidora de Produtos Agro-Pecuários, S.A.

Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha

Tel: +351 - 263 406 570

România

Boehringer Ingelheim RCV GmbH & Co KG

Animal Health

Dr. Boehringer-Gasse 5-11

1121 Viena

AUSTRIA

Tel. +43 1 80 105 0

Slovenija

Boehringer Ingelheim RCV GmbH & Co KG

Animal Health

Dr. Boehringer-Gasse 5-11

1121 Dunaj

AVSTRIJA

Tel. +43 1 80 105 0

Ísland

Slovenská republika

Vistor hf.

Boehringer Ingelheim RCV GmbH & Co KG

Sími: +354- 535 7000

Animal Health

 

Dr. Boehringer-Gasse 5-11

 

1121 Viedeň

 

RAKÚSKO

 

Tel. +43 1 80 105 0

Italia

Suomi/Finland

Boehringer Ingelheim Italia S.p.A.

Vetcare Oy

Via Lorenzini 8

PL/PB 99

20139 Milano

FI-24101 Salo

Tel: +39 02 5355 1

Puh/Tel: +358- (0) 20 144 3360

Κύπρος

Sverige

Boehringer Ingelheim Animal Health GmbH

Boehringer Ingelheim Vetmedica

Binger Str. 173,

Box 467

55216 Ingelheim/Rhein

SE-201 24 Malmö

ΓΕΡΜΑΝΊΑ

Tel: +46- (0) 40 23 34 00

Tel. +49 6132 77 6720

 

Latvija

Lietuva

Boehringer Ingelheim RCV GmbH & Co KG

Boehringer Ingelheim RCV GmbH & Co KG

Animal Health

Animal Health

Dr. Boehringer-Gasse 5-11

Dr. Boehringer-Gasse 5-11

1121 Vīne

1121 Viena

AUSTRIJA

AUSTRIJA

Tel. +43 1 80 105 0

Tel. +43 1 80 105 0

United Kingdom

Republika Hrvatska

Boehringer Ingelheim Limited,

Boehringer Ingelheim RCV GmbH & Co KG

Ellesfield Avenue,

Animal Health

Bracknell, Berkshire, RG12 8YS,

Dr. Boehringer-Gasse 5-11

Tel: +44- (0) 1344 424 600

1121 Beč

 

AUSTRIJA

 

Tel. +43 1 80 105 0

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