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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: 27/07/2010
SPC Haemate P 500 and 1000 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 27/07/2010 and displayed until Current
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • 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:   15-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Most of the changes are administrative and are intended to improve clarity. The section 4.4 change is to correct an error in the sodium content, while section 5.2 shows revised pK values.  
Updated on 15/06/2010 and displayed until 27/07/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   25-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 2, a typographical error regarding the dilution volume of the 1000 IU strength has been corrected.
Updated on 05/09/2008 and displayed until 15/06/2010
Reasons for adding or updating:
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   25-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
NO changes, merging 2 SPCs into 1.
Updated on 11/04/2007 and displayed until 05/09/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • SPC Retired pending re-submission
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7- Manufacturer's name changed to CSL Behring
Updated on 11/04/2007 and displayed until 11/04/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7: Manufacturer name changed to CSL Behring
Updated on 22/02/2007 and displayed until 11/04/2007
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Combined SPC to cover all presentations
Updated on 21/09/2006 and displayed until 22/02/2007
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Joint SPC superseded by SPCs for individual presentations
Date of revision of text on the SPC:   12/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 - Volume of diluent changed to 10ml and 15ml for 500IU and 1000IU respectively.
Updated on 23/06/2006 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   12/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2

The VWF:RCof per vial in Haemate P 500IU when reconstituted has changed from 1100 IU to 1200 IU

The VWF: RCof per vial in Haemate P 1000IU when reconsituted has changed from 2200IU to 2400IU

The volume of WFI provided with Haemate P 500IU has changed from 20ml to 10ml

The volume of WFI provided with Haemate P 1000IU has changed from 30ml to 15ml

 

Section 4.2

Under von Willebrand's disease: 40IU to 80IU vWF:RCof corresponds to 16-32 IU has changed to 17-33IU

 

Section 5.2

Registration mark taken off Haemate P for consistency

 

Section 6.4

Additional advise on labelling of expiry date on room temperature storage products: "The revised expiry date...... it should be discarded"

 

Section 10

Revision of text date has updated to 22 December 2005 to reflect all the above upate
Updated on 21/09/2005 and displayed until 23/06/2006
Reasons for adding or updating:
  • Change to section 8 - MA number
  • Change to joint SPC covering all presentations
Updated on 06/04/2005 and displayed until 21/09/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/04/2005 and displayed until 06/04/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 09/08/2001 and displayed until 06/04/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 07/08/2001 and displayed until 09/08/2001
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 01/08/2001 and displayed until 07/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 13/07/2000 and displayed until 01/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 09/03/2000 and displayed until 13/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 09/03/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  factor VIII
  von willebrand factor