Last Updated on eMC 21-11-2017 View medicine  | CSL Behring UK Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:25-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Changes to section 6.5 are due to reorganization of the pack contents for a new packaging line.

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 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:13-08-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

All changes are administrative in nature and were assessed during the licensing procedure for Berinert 1500 IU.

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:13-11-2013

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

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:01-04-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of new indication, pre-procedure prevention

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:28-03-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to add an indication, pre-procedure prevention 

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC:30-06-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

ATC code has been revised by WHO

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:05-04-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Correct a typo 'U' to 'IU'

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:05-04-2012

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'.

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:02-12-2011

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. 

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:18-05-2011

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. 

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES