Rapilysin

reteplase

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

What is Rapilysin?

Rapilysin is a powder and solvent that are made up into a solution for injection. It contains the active substance reteplase.

What is Rapilysin used for?

Rapilysin is used within 12 hours of a suspected heart attack to help dissolve the blood clots obstructing the flow of blood to the heart muscle.

The medicine can only be obtained with a prescription.

How is Rapilysin used?

Rapilysin should be prescribed by doctors who have experience in using medicines that dissolve blood clots and who can monitor its use.

Treatment with Rapilysin should be started as soon as possible after the start of heart attack symptoms. Rapilysin is given as two injections, 30 minutes apart. Each injection is given into a vein slowly, but in less than two minutes. Other medicines that prevent clotting (aspirin and heparin) should be given before and after the Rapilysin injection to stop clots from forming again. However, Rapilysin and heparin or aspirin must not be given in the same syringe.

How does Rapilysin work?

The active substance in Rapilysin, reteplase, is a copy of a natural enzyme called t‑PA that has been modified so that it starts working faster and for longer. Reteplase activates the production of an enzyme called plasmin, which breaks up blood clots. Following a heart attack, Rapilysin can help dissolve blood clots that have formed in the arteries supplying the heart muscle, thereby restoring normal blood flow to the heart.

How has Rapilysin been studied?

Rapilysin has been studied in more than 21,000 patients in four studies. Rapilysin has been compared with other medicines used to dissolve blood clots: streptokinase in 6,000 patients and alteplase in about 15,000 patients. The studies looked at the number of patients who had died 30 to 35 days after treatment, and at the number of patients who had heart failure (an inability of the heart to pump enough blood around the body) or a stroke.

What benefit has Rapilysin shown during the studies?

Rapilysin was more effective than streptokinase in reducing the number of patients with heart failure, and it was as effective as streptokinase in preventing death. Rapilysin was also as effective as alteplase in preventing death and stroke.

What is the risk associated with Rapilysin?

The most common side effects with Rapilysin (seen in more than 1 patient in 10) are bleeding at the injection site, recurrent ischaemia (reduced blood supply to parts of the body) or angina (severe chest pain), hypotension (low blood pressure), heart failure or pulmonary oedema (build-up of fluid on the lungs), and reactions at the site of the injection, such as burning sensations. For the full list of all side effects reported with Rapilysin, see the package leaflet.

Rapilysin must also not be used in patients who are at risk of bleeding because of other diseases, treatment with other medicines, high blood pressure, previous bleeding or recent surgery. For the full list of restrictions, see the package leaflet.

Why has Rapilysin been approved?

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

Other information about Rapilysin

The European Commission granted a marketing authorisation valid throughout the European Union for Rapilysin on 9 November 1996.

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

Name Language First published Last updated
Rapilysin : EPAR - Summary for the public BG = bălgarski 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public ES = español 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public CS = čeština 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public DA = dansk 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public DE = Deutsch 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public ET = eesti keel 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public EL = elliniká 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public EN = English 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public FR = français 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public IT = italiano 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public LV = latviešu valoda 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public LT = lietuvių kalba 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public HU = magyar 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public MT = Malti 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public NL = Nederlands 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public PL = polski 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public PT = português 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public RO = română 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public SK = slovenčina 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public SL = slovenščina 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public FI = suomi 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public SV = svenska 11/07/2006 09/03/2016
Rapilysin : EPAR - Summary for the public HR = Hrvatski 11/07/2006 09/03/2016

This EPAR was last updated on 10/03/2016 .

Authorisation details

Product details

Product details for Rapilysin
NameRapilysin
Agency product numberEMEA/H/C/000105
Active substance

reteplase

International non-proprietary name (INN) or common name

reteplase

Therapeutic area Myocardial Infarction
Anatomical therapeutic chemical (ATC) code B01AD08

Publication details

Publication details for Rapilysin
Marketing-authorisation holder

Actavis Group PTC ehf

Revision21
Date of issue of marketing authorisation valid throughout the European Union29/08/1996

Contact address:

Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland

Product information

Product information

04/03/2016  Rapilysin -EMEA/H/C/000105 -N/0061

Name Language First published Last updated
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016
Rapilysin : EPAR - Product Information HR = Hrvatski 13/08/2008 10/03/2016

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
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - All Authorised presentations HR = Hrvatski 11/07/2006  

Pharmacotherapeutic group

B01 Antithrombotic agents

Therapeutic indication

Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction symptoms.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Rapilysin : EPAR - Procedural steps taken before authorisation HR = Hrvatski 11/07/2006  
Rapilysin : EPAR - Scientific Discussion HR = Hrvatski 11/07/2006  

Authorised

This medicine is approved for use in the European Union

More information on Rapilysin