Brinavess

vernakalant hydrochloride

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This is a summary of the European public assessment report (EPAR) for Brinavess. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Brinavess.

What is Brinavess?

Brinavess is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance vernakalant hydrochloride.

What is Brinavess used for?

Brinavess is used to rapidly restore normal heart rhythm in adult patients (aged 18 years or over) who have recently started having atrial fibrillation. Atrial fibrillation happens when the atria (the upper chambers of the heart) contract irregularly and rapidly, resulting in abnormal heart rhythm. Brinavess is to be used for fibrillation that has started within the last seven days, or within the last three days if the patient had recently had heart surgery.

The medicine can only be obtained with a prescription.

How is Brinavess used?

Brinavess should be given by a qualified healthcare professional in a setting where the patient’s heart can be properly monitored. The healthcare professional should monitor the patient during and for at least 15 minutes after administration of the medicine.

Patients in atrial fibrillation should receive 3 mg per kilogram body weight given as a 10-minute infusion into a vein. If the heart rhythm has not returned to normal 15 minutes after the first infusion has been given, a second dose of 2 mg/kg should be given. Patients should not be given more than 5 mg/kg of Brinavess within any 24-hour period. For more information on the use of Brinavess, see the summary of product characteristics (also part of the EPAR).

How does Brinavess work?

The active substance in Brinavess, vernakalant, is an anti-arrhythmic medicine. It restores normal heart rhythm by blocking channels through which charged particles of potassium and sodium move in and out of the muscle cells in the atria. By blocking these channels, vernakalant can prevent abnormal electrical activity that can lead to atrial fibrillation. Vernakalant acts mainly in the atria rather than in the ventricles (the lower chambers of the heart).

How has Brinavess been studied?

In two main studies involving 596 adults with atrial fibrillation, Brinavess was compared with placebo (a dummy treatment). A third main study compared Brinavess with placebo in 161 adults who had had atrial fibrillation following heart surgery. The main measure of effectiveness was the proportion of patients whose heart rhythm returned to normal.

What benefit has Brinavess shown during the studies?

Brinavess was more effective than placebo at treating patients who had recently started having atrial fibrillation. In the first two studies, among patients who had recently started having atrial fibrillation, heart rhythm returned to normal in 51% of those receiving Brinavess (118 out of 231) compared with 4% (6 out of 159) of those taking placebo. In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo.

What is the risk associated with Brinavess?

The most common side effects with Brinavess (seen in more than 1 patient in 10) are dysgeusia (taste disturbances) and sneezing. For the full list of all side effects reported with Brinavess, see the package leaflet.

Brinavess should not be used in people who may be hypersensitive (allergic) to vernakalant hydrochloride or any of the other ingredients. It must not be used in patients with severe aortic stenosis (narrowing of the aorta), low systolic blood pressure (blood pressure when the heart is contracting), advanced heart failure (when the heart does not pump enough blood around the body), some types of altered electrical activity in the heart or a very slow heart rate. Brinavess must not be given within 30 days of having acute coronary syndrome (a group of heart problems that include unstable angina and heart attacks). Patients on Brinavess must not be given medicines called ‘class-I and -III anti-arrhythmics’ intravenously during the four hours before or after their Brinavess infusion.

Why has Brinavess been approved?

The CHMP decided that Brinavess’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Brinavess?

The company that makes Brinavess will ensure that healthcare professionals expected to use the medicine in all Member States are provided with educational material explaining how the medicine should be used.

Other information about Brinavess

The European Commission granted a marketing authorisation valid throughout the European Union for Brinavess on 1 September 2010.

For more information about treatment with Brinavess, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Brinavess : EPAR - Summary for the public BG = bălgarski 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public ES = español 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public CS = čeština 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public DA = dansk 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public DE = Deutsch 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public ET = eesti keel 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public EL = elliniká 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public EN = English 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public FR = français 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public IT = italiano 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public LV = latviešu valoda 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public LT = lietuvių kalba 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public HU = magyar 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public MT = Malti 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public NL = Nederlands 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public PL = polski 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public PT = português 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public RO = română 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public SK = slovenčina 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public SL = slovenščina 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public FI = suomi 28/09/2010 23/07/2012
Brinavess : EPAR - Summary for the public SV = svenska 28/09/2010 23/07/2012

This EPAR was last updated on 29/09/2015 .

Authorisation details

Product details

Product details for Brinavess
NameBrinavess
Agency product numberEMEA/H/C/001215
Active substance

vernakalant hydrochloride

International non-proprietary name (INN) or common name

vernakalant hydrochloride

Therapeutic area Atrial Fibrillation
Anatomical therapeutic chemical (ATC) code C01BG11

Publication details

Publication details for Brinavess
Marketing-authorisation holder

Cardiome UK Limited

Revision8
Date of issue of marketing authorisation valid throughout the European Union01/09/2010

Contact address:

Cardiome UK Limited 
Lakeside House 
1 Furzeground Way 
Stockley Park 
Uxbridge 
Middlesex 
UB11 1BD
United Kingdom

Product information

Product information

28/07/2015  Brinavess -EMEA/H/C/001215 -R/0023

Name Language First published Last updated
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015
Brinavess : EPAR - Product Information SV = svenska 28/09/2010 29/09/2015

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
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  
Brinavess : EPAR - All Authorised presentations SV = svenska 28/09/2010  

Name Language First published Last updated
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012
Brinavess : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 28/09/2010 23/07/2012

Pharmacotherapeutic group

Cardiac therapy

Therapeutic indication

Rapid conversion of recent-onset atrial fibrillation to sinus rhythm in adults:

  • for non-surgery patients: atrial fibrillation ≤ 7 days duration;
  • for post-cardiac-surgery patients: atrial fibrillation ≤ 3 days duration.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Brinavess : EPAR - Public assessment report SV = svenska 28/09/2010  
CHMP positive summary of opinion for Brinavess SV = svenska 25/06/2010  

Authorised

This medicine is approved for use in the European Union