Evicel

human fibrinogen / human thrombin

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

What is Evicel?

Evicel is a medicine that is used as a sealant (glue). It is available as two solutions, one containing the active substance human clottable protein (50 to 90 mg/ml), and the other containing the active substance human thrombin (800 to 1200 international units per millilitre).

What is Evicel used for?

Evicel is a medicine that is used as a sealant (glue). It is available as two solutions, one containing the active substance human clottable protein (50 to 90 mg/ml), and the other containing the active substance human thrombin (800 to 1200 international units per millilitre).

How is Evicel used?

Evicel should only be used by an experienced surgeon who has been trained in the use of Evicel. Before use, the two solutions of Evicel are mixed together using a special device that is supplied with the medicine. Evicel is then dripped or sprayed on the surface of the wound until it forms a thin layer. The volume of Evicel to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.

How does Evicel work?

The active substances in Evicel, human clottable protein and thrombin, are natural substances obtained from human plasma (the liquid part of the blood). The human clottable protein contains, as its main component, fibrinogen, a protein involved in the natural clotting process.

When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin. The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.

How has Evicel been studied?

Because the thrombin solution of Evicel is also used in another medicine, Quixil, the company used some data from Quixil to support the use of Evicel. 

Evicel has been studied in two main studies involving a total of 282 patients. The first study compared Evicel with manual compression (applying direct pressure) in reducing bleeding during vascular surgery. The main measure of effectiveness was the number of patients with no bleeding (haemostasis) at the site of application, four minutes after having received Evicel or manual compression. 

The second study compared Evicel with Surgicel (a material used to help control bleeding) in reducing bleeding during abdominal surgery (surgery of organs in the tummy). The main measure of effectiveness was the number of patients with no bleeding at the site of application, 10 minutes after having received Evicel or Surgicel. Evicel has also been studied in one further main study involving 139 patients undergoing brain surgery and whose dura mater was leaking fluid following suturing of the dural incision. The study compared the effectiveness of Evicel in addition to sutures with sutures alone in sealing the dura mater. The main measure of effectiveness was the number of patients whose dura-mater closure was watertight with no leakage.

What benefit has Evicel shown during the studies?

Evicel was more effective than the comparator treatments in reducing the bleeding at the site of application. In vascular surgery, 85% of the patients had no bleeding four minutes after treatment with Evicel (64 out of 75), compared with 39% of the patients treated with manual compression (28 out of 72). During abdominal surgery, 95% of the patients had no bleeding 10 minutes after treatment with Evicel (63 out of 66), compared with 81% of the patients treated with Surgicel (56 out of 69). 

In dura-mater closure, 92% of patients treated with Evicel (82 out of 89) had a watertight closure compared with 38% of the patients who did not receive Evicel (19 out of 50).

What is the risk associated with Evicel?

As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly. In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting. Thromboembolic complications (blood clots) may occur if Evicel is unintentionally injected into a blood vessel. Cases of gas embolism (gas bubbles in the blood that affect the blood flow) have occurred when Evicel was applied as spray. For the full list of all side effects reported with Evicel, see the package leaflet. 

Evicel must not be used in people who are hypersensitive (allergic) to human clottable protein, thrombin or any of the other ingredients. It must not be given as an injection into a blood vessel. 

When used in endoscopic procedures (procedures that use an endoscope for viewing internal organs), Evicel must not be applied as a spray. Evicel must also not be used in dura-mater closure if the dura mater cannot be sutured, or if there are gaps greater than 2 mm after suturing. Evicel must also not be used as a glue for the fixation of dural patches (material which is sewn over an opening in the dura mater).

For further details see the package leaflet.

Why has Evicel been approved?

The CHMP decided that Evicel’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 Evicel?

In order to reduce the risk of gas embolism with spray application, the company will provide educational material and training to all surgeons who will use Evicel as a spray. In addition, the company will ensure that Evicel is used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that the regulators contain labels stating the recommended pressure and distance for the spray application.

Other information about Evicel

The European Commission granted a marketing authorisation valid throughout the European Union for Evicel on 6 October 2008.

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

Name Language First published Last updated
Evicel : EPAR - Summary for the public BG = bălgarski 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public ES = español 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public CS = čeština 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public DA = dansk 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public DE = Deutsch 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public ET = eesti keel 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public EL = elliniká 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public EN = English 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public FR = français 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public IT = italiano 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public LV = latviešu valoda 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public LT = lietuvių kalba 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public HU = magyar 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public MT = Malti 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public NL = Nederlands 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public PL = polski 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public PT = português 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public RO = română 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public SK = slovenčina 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public SL = slovenščina 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public FI = suomi 09/12/2008 17/09/2013
Evicel : EPAR - Summary for the public SV = svenska 09/12/2008 17/09/2013

This EPAR was last updated on 13/01/2016 .

Authorisation details

Product details

Product details for Evicel
NameEvicel
Agency product numberEMEA/H/C/000898
Active substance

human fibrinogen / human thrombin

International non-proprietary name (INN) or common name

human fibrinogen / human thrombin

Therapeutic area Hemostasis, Surgical
Anatomical therapeutic chemical (ATC) code B02BC

Publication details

Publication details for Evicel
Marketing-authorisation holder

Omrix Biopharmaceuticals S.A.

Revision12
Date of issue of marketing authorisation valid throughout the European Union06/10/2008

Contact address:

Omrix Biopharmaceuticals S.A.
200 Chaussée de Waterloo
BE-1640 Rhode-St-Genèse
Belgium

Product information

Product information

19/11/2015  Evicel -EMEA/H/C/000898 -II/0032

Name Language First published Last updated
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016
Evicel : EPAR - Product Information SV = svenska 13/05/2009 13/01/2016

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
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  
Evicel : EPAR - All Authorised presentations SV = svenska 09/12/2008  

Pharmacotherapeutic group

Antihaemorrhagics

Therapeutic indication

Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.

Evicel is also indicated as suture support for haemostasis in vascular surgery.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Evicel : EPAR - Public assessment report SV = svenska 09/12/2008  
Committee for medicinal products for human use summary of positive opinion for Evicel SV = svenska 24/07/2008  

Authorised

This medicine is approved for use in the European Union

More information on Evicel