Semintra

telmisartan

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An overview of Semintra and why it is authorised in the EU

Semintra is a veterinary medicine used in cats to reduce proteinuria (protein in the urine) and to treat high blood pressure. Proteinuria can occur with chronic (long-term) kidney disease in cats, a common disease in elderly cats characterised by a progressive deterioration of kidney function over time. High blood pressure is also a long term problem of ageing cats which can occur with chronic kidney disease, hyperthyroidism (overactive thyroid gland) and other conditions.

How is Semintra used?

Semintra is available as a solution to be given by mouth and can only be obtained with a veterinary prescription. Two different strengths are available: 4 mg/ml to reduce proteinuria and 10 mg/ml to treat high blood pressure. The medicine is given once a day by mouth using the measuring syringe provided. The recommended dose to reduce proteinuria is 1 mg telmisartan per kg bodyweight. To treat high blood pressure an initial dose of 2 mg telmisartan per kg bodyweight is used. After 4 weeks the dose can be reduced in cats with systolic blood pressure (SBP) of less than 140 mmHg. The target SBP is between 120 and 140 mmHg.

How does Semintra work?

The active substance in Semintra, telmisartan, is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that constricts blood vessels). By blocking the receptor to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to expand. This allows blood pressure to drop with a resulting decrease in protein in the urine which may slow down progression of kidney disease.

What benefits of Semintra have been shown in studies?

In a field study involving 224 cats with chronic kidney disease, aged mainly over 11 years, Semintra was as effective as benazepril, another veterinary medicine used to reduce proteinuria, in reducing proteinuria. Semintra decreased protein in the urine within the first seven days after the start of treatment.

In a second field study involving 294 cats with hypertension with average age 13 years, 194 cats given Semintra once a day for 28 days had a reduction of SBP of 25 mmHg at day 28 compared to 11 mmHg for 100 cats given placebo (a dummy treatment). At the end of the 28 days Semintra treated cats continued to be treated for an additional 92 days and these cats had a reduction of SBP of more than 20 mmHg for the entire 4 month study period.

What are the risks associated with Semintra?

The most common side effects seen with Semintra are mild and short-lived vomiting and diarrhoea (which may affect up to 1 in 10 cats treated with the 10 mg/ml strength solution).

For a full list of all side effects reported with Semintra, see the package leaflet.

Semintra must not be given to pregnant or lactating cats.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

If Semintra is swallowed accidentally, medical advice should be sought immediately and the package leaflet or label shown to the doctor. The person administering Semintra should avoid getting it in their eyes. If contact with the eyes occurs they should be rinsed with water. Hands should be washed after giving the medicine. Pregnant women should take special care to avoid contact with the product. People who are hypersensitive to telmisartan or other angiotensin II receptor antagonists should avoid contact with Semintra.

Why is Semintra authorised in the EU?

The European Medicines Agency decided that Semintra’s benefits are greater than its risks and it can be authorised for use in the EU.

Other information about Semintra:

Semintra received a marketing authorisation valid throughout the EU, on 13 February 2013.

Further information on Semintra can be found on the Agency’s website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.

Name Language First published Last updated
Semintra : EPAR - Summary for the public BG = bălgarski 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public ES = español 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public CS = čeština 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public DA = dansk 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public DE = Deutsch 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public ET = eesti keel 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public EL = elliniká 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public EN = English 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public FR = français 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public IT = italiano 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public LV = latviešu valoda 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public LT = lietuvių kalba 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public HU = magyar 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public MT = Malti 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public NL = Nederlands 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public PL = polski 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public PT = português 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public RO = română 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public SK = slovenčina 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public SL = slovenščina 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public FI = suomi 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public SV = svenska 2013-02-28 2018-06-25
Semintra : EPAR - Summary for the public HR = Hrvatski 2013-02-28 2018-06-25

This EPAR was last updated on 25/06/2018 .

Authorisation details

Product details

Product details for Semintra
NameSemintra
Agency product numberEMEA/V/C/002436
Active substance

telmisartan

International non-proprietary name (INN) or common name

telmisartan

Species Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes QC09CA07



Publication details

Publication details for Semintra
Marketing-authorisation holder

Boehringer Ingelheim Vetmedica GmbH

Revision5
Date of issue of marketing authorisation valid throughout the European Union13/02/2013

Contact address:

Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 73
55216 Ingelheim am Rhein
Germany

Product information

Product information

08/05/2018  Semintra -EMEA/V/C/002436 -X/0008

Name Language First published Last updated
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - Product Information HR = Hrvatski 2013-02-28 2018-06-25

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25
Semintra : EPAR - All Authorised presentations HR = Hrvatski 2013-02-28 2018-06-25

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system, angiotensin II antagonists, plain.

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Semintra : EPAR - Public assessment report HR = Hrvatski 2013-02-28  
CVMP summary of positive opinion for Semintra HR = Hrvatski 2012-12-14