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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: 08/09/2011
SPC Helixate NexGen

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 08/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   22-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of MAH name
Updated on 11/01/2011 and displayed until 08/09/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The main change is to section 6.4 - extension of room temperature storage from 3 months to 12 months for all strengths. Changes to other sections are administrative in nature.
Updated on 02/09/2010 and displayed until 11/01/2011
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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   06-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Licences renewed. Change are mainly administrative.
Updated on 06/07/2010 and displayed until 02/09/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   28-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The shelf life of Helixate NexGen 2000 IU has been extended to 30 months in line with all the other strengths.
Updated on 29/04/2010 and displayed until 06/07/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 3 - Shelf Life
  • 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:   26-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2, addition of new sentence. For continuous infusion, bags should be changed every 24 hours.
Section 6.3, reduction in storage time for reconstituted solution from 48 to 24 hours, in PVC bags for continuous infusion.
Section 6.6, addition of new sentence. For continuous infusion, product must be prepared under aseptic conditions.
Section 10, new revision date 26 March 2010  
Updated on 21/10/2009 and displayed until 29/04/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.8 – undesirable effects updated

6.3 – no actual change, but different shelf life for 2000 IU strength highlighted

6.5 – change to solvent vial size and glass

7 – change of MAH

9 – no actual change, but different authorisation date for 2000 IU strength highlighted

10 – change to revision date (as always)
Updated on 02/06/2008 and displayed until 21/10/2009
Reasons for adding or updating:
  • Introduction of new pack/pack size
Date of revision of text on the SPC:   30-Oct-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of 2000 IU vial size to the exisiting Helixate NexGen range.
Updated on 18/09/2002 and displayed until 02/06/2008
Reasons for adding or updating:
  • Change to section 8 - MA number
Updated on 17/09/2001 and displayed until 18/09/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
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