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CSL Behring UK Limited

Hayworth House, Market Place, Haywards Heath, West Sussex, RH16 1DB, UK
Telephone: +44 (0)1444 447 400
Fax: +44 (0)1444 447 403
WWW: http://www.cslbehring.co.uk
Medical Information Direct Line: +44 (0)1444 447 405
Medical Information e-mail: medinfo@cslbehring.com
Customer Care direct line: +44 (0)1444 447 402
Out of Hours contact: +44 (0)1444 447 405

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 27/11/2013
SPC Berinert 500 IU

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 27/11/2013 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Nov-2013
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

2, Qualitative and Quantitative composition. Update in line with the QRD template.

4.3, Contraindications. Update in line with the QRD template.

4.6, Fertility, prenancy and lactation. Update in line with the QRD template.

4.7, Effects on ability to drive and use machines. Update in line with the QRD template.

4.8 Undesirable effects. Update in line with the QRD template to add information concerning 'Reporting of suspected adverse reactions'. Healthcare professionals are asked to report via the UK Yellow Card Scheme.

6.3 Shelf life. Advice to store reconstituted product only in the vial has been added.

6.4 Special precautions for storage. Updated in line with the QRD template.

6.6 Special precautions for disposal. Advice to use the syringe provided with the product has been added to the 'General instructions' and to 'Reconstitution' Step 7.

9. Date of first authorisation/renewal of the authorisation. Updated to show the renewal date, 12/12/2013.

10. Date of revision of the text. Revision date updated to 13/11/2013
Updated on 17/04/2013 and displayed until 27/11/2013
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2013
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Addition of new indication, pre-procedure prevention
Updated on 02/04/2013 and displayed until 17/04/2013
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Mar-2013
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to add an indication, pre-procedure prevention 
Updated on 15/08/2012 and displayed until 02/04/2013
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   30-Jun-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

ATC code has been revised by WHO
Updated on 18/06/2012 and displayed until 15/08/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   05-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Correct a typo 'U' to 'IU'
Updated on 27/04/2012 and displayed until 18/06/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Two variations have recently been approved and both are included here. 1) Home treatment and 2) Change of 'Units' to 'IU'.
Updated on 19/12/2011 and displayed until 27/04/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use
The information provided under the sub-heading 'Virus safety' has been revised;
  • The measures taken that are considered effective for non-enveloped viruses now include parvovirus B19,
  • The following information has been deleted; 

The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.

 

Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).

All remaining text is unchanged. 

Updated on 26/05/2011 and displayed until 19/12/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Removal of black triangle from SmPC as it is no longer required. 
Updated on 20/04/2009 and displayed until 26/05/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics