Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

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: 05/04/2011
SPC Fibrogammin P

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 05/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   21-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The changes are all administrative in nature.
Updated on 26/10/2010 and displayed until 05/04/2011
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 6. 3 - Shelf Life
  • Change to section 6.1 - List of Excipients
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   12-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The changes are administrative in nature.
Updated on 29/09/2010 and displayed until 26/10/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   23-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The name of the pharmacotherapeutic category has been revised.
Updated on 03/08/2010 and displayed until 29/09/2010
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 10 date of revision of the text
Date of revision of text on the SPC:   27-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The change is from Units (U) to International Units (IU) following approval of a new specific Factor XIII assay.
Updated on 28/03/2007 and displayed until 03/08/2010
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 - Marketing authorisation holder - name changed from ZLB Behring to CSL Behring
Updated on 09/03/2007 and displayed until 28/03/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 and section6 - removal of the 1250IU presentation.
Updated on 21/09/2006 and displayed until 09/03/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - table re-formated following previous submission
Section 4.4, 6.5 and 6.6 - headings re-formatted
Updated on 19/09/2006 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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5 - Pharmacological Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2: sub sections merged. Product description changed from Human plasma coagulation factor XIII to "Fibrogammin P is a purfified concentrate of blood coagulation......" taken from Section 3 in previous version

"dried substance" changed to "powder" in the table

 

Section 4.2: Table reformatted.  Addition of  " In acute bleeding episodes,....... doses up to 50 U/kg"

 

Section 4.4:

  • 4th paragraph moved to the top of the section;
  • examples of "known allergies" provided in this version; 
  • additional caution statement added in case of existing thrombosis to read: caution should be exercised on account of the fibrin-stabilitzing effect of factor XIII.
  • Under notes for diabetic patients: amount of glucose in Fibrogammin changed from 96mg per 1000U to 16-24mg per 250U
  • The maximum dose of glucose to be supplied for a given body weight is provided
  • Virus Safety: whole section has been revised

Section: 4.8:

  • allergic is replaced with allergic-anaphylactic
  • examples of allergic anaphylactic reactions are provided
  • references to section 4.4. with regard to side effects and transmissible agents are included

Section 5.1

  • removed sub headings 5.1.1 and 5.1.2 
  • Revised text for the pharmacodynamic activity

Section 6.5 -replace the word "dried substance" with "powder"

Section 6.6- Information with regard to the disposal of unused solution moved

Section 10 - date or revision changed to 4th September 2006

 
Updated on 31/03/2006 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 06/04/2005 and displayed until 31/03/2006
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 09/09/2003 and displayed until 06/04/2005
Reasons for adding or updating:
  • 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 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 01/08/2001 and displayed until 09/09/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 20/07/2000 and displayed until 01/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 09/03/2000 and displayed until 20/07/2000
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 XIII