Vibativ

telavancin

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This is a summary of the European public assessment report (EPAR) for Vibativ. 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 Vibativ.

What is Vibativ?

Vibativ is a medicine that contains the active substance telavancin. It is available as a powder to be made up into a solution for infusion (drip into a vein).

What is Vibativ used for?

Vibativ is used to treat adults with nosocomial pneumonia (an infection of the lungs). ‘Nosocomial’ means the infection was caught in hospital. This includes pneumonia caused by the use of a ventilator (a machine used in hospitals that helps patients to breathe). Vibativ is used only when the infection is known or believed to be caused by bacteria called ‘methicillin-resistant Staphylococcus aureus’ (MRSA) and when other treatments (such as other antibiotics) are not suitable.

The medicine can only be obtained with a prescription.

How is Vibativ used?

Vibativ is given as a drip into a vein lasting one hour. The recommended dose is 10 mg per kg body weight once every 24 hours, for seven to 21 days. Kidney function should be monitored and the initial and subsequent doses may have to be lowered for patients with minor kidney problems, while treatment may need to be stopped if kidney function gets markedly worse.

How does Vibativ work?

The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides’. It works by stopping the bacteria causing the infection from making their own cell walls and by disrupting their cell membranes, thereby killing the S aureus bacteria causing the infection.

MRSA is a S aureus bacteria that is resistant to commonly used antibiotics known as penicillins (including methicillin and oxacillin) and cephalosporins. Telavancin is used to treat MRSA because it can still work against bacteria that are resistant to these medicines.

How has Vibativ been studied?

The effects of Vibativ were first tested in experimental models before being studied in humans.

Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 1,503 adults with nosocomial pneumonia caused by Gram-positive bacteria (types of bacteria that include MRSA). The antibiotics were given for up to 21 days. Vibativ was also compared with vancomycin in two main studies involving a total of 1,897 adults with complicated infections of the skin and soft tissue below the skin caused by Gram-positive bacteria, where the medicines were given for up to 14 days. In all the studies, the main measure of effectiveness was the number of patients whose infection had been cured after the end of treatment.

What benefit has Vibativ shown during the studies?

Vibativ was as effective as the comparator medicine at curing nosocomial pneumonia and complicated infections of the skin and soft tissue. In the first study in nosocomial pneumonia, 58% of patients treated with Vibativ (214 out of 372) were cured after treatment compared with 59% of patients treated with vancomycin (221 out of 374). In the second study, 60% of patients treated with Vibativ (227 out of 377) were cured after treatment compared with 60% of patients treated with vancomycin (228 out of 380).

In the first study in complicated infections of the skin and soft tissue, 76% of patients treated with Vibativ (323 out of 426) were cured after treatment compared with 75% treated with vancomycin (321 out of 429). In the second study, 77% of patients treated with Vibativ (387 out of 502) were cured after treatment compared with 74% of those treated with vancomycin (376 out of 510).

What is the risk associated with Vibativ?

The most common side effects with Vibativ (seen in more than 1 patient in 10) are dysgeusia (taste disturbances) and nausea (feeling sick). Studies showed that more patients developed kidney problems following treatment with Vibativ than with vancomycin (3.8% versus 2.2%). For the full list of all side effects reported with Vibativ, see the package leaflet.

Vibativ should not be used in people who may be hypersensitive (allergic) to telavancin or any of the other ingredients. It must not be given to patients with severe kidney problems or acute (sudden) kidney failure. It must not be given to pregnant women.

Why has Vibativ been approved?

The CHMP concluded that, although Vibativ had been shown to be effective in treating both nosocomial pneumonia and complicated infections of the skin and soft tissue, its toxic effect on the kidneys was an important safety concern. However, the Committee considered that Vibativ could be valuable for treating patients with nosocomial pneumonia known or believed to be caused by MRSA for whom other treatments are not suitable. Therefore, the CHMP decided that Vibativ’s benefits are only greater than its risks for patients who are severely ill with nosocomial pneumonia and are under close observation in hospital, and recommended that it be given marketing authorisation.

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

The company that markets Vibativ will ensure all doctors who are expected to prescribe or use Vibativ receive an educational pack containing a letter and a guide setting out important safety information on the correct use of Vibativ.

Other information about Vibativ

The European Commission granted a marketing authorisation valid throughout the European Union for Vibativ on 2 September 2011.

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

Name Language First published Last updated
Vibativ : EPAR - Summary for the public BG = bălgarski 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public ES = español 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public CS = čeština 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public DA = dansk 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public DE = Deutsch 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public ET = eesti keel 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public EL = elliniká 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public EN = English 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public FR = français 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public IT = italiano 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public LV = latviešu valoda 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public LT = lietuvių kalba 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public HU = magyar 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public MT = Malti 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public NL = Nederlands 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public PL = polski 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public PT = português 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public RO = română 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public SK = slovenčina 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public SL = slovenščina 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public FI = suomi 28/09/2011 31/03/2014
Vibativ : EPAR - Summary for the public SV = svenska 28/09/2011 31/03/2014

This EPAR was last updated on 01/12/2014 .

Authorisation details

Product details

Product details for Vibativ
NameVibativ
Agency product numberEMEA/H/C/001240
Active substance

telavancin

International non-proprietary name (INN) or common name

telavancin

Therapeutic area Cross InfectionPneumonia, Bacterial
Anatomical therapeutic chemical (ATC) code J01XA03
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Vibativ
Marketing-authorisation holder

Clinigen Healthcare Ltd

Revision5
Date of issue of marketing authorisation valid throughout the European Union02/09/2011

Contact address:

Clinigen Healthcare Ltd
Pitcairn House
Crown Square
First Avenue
Burton-on-Trent
Staffordshire
DE14 2WW
United Kingdom

Product information

Product information

25/09/2014  Vibativ -EMEA/H/C/001240 -II/0015

Name Language First published Last updated
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - Product Information SV = svenska 28/09/2011 01/12/2014

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
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014
Vibativ : EPAR - All Authorised presentations SV = svenska 28/09/2011 01/12/2014

Name Language First published Last updated
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014
Vibativ : EPAR - Conditions imposed on member states for safe and effective use SV = svenska 28/09/2011 31/03/2014

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA).

Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vibativ : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 21/08/2012 01/12/2014
Vibativ-H-C-1240-A20-01 : EPAR - Assessment Report - Article 20 SV = svenska 21/08/2012 31/03/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Vibativ : EPAR - Public assessment report SV = svenska 28/09/2011 31/03/2014
CHMP summary of positive opinion for Vibativ SV = svenska 19/05/2011 31/03/2014