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BPL (Bio Products Laboratory)
Dagger Lane, Elstree, Hertfordshire, WD6 3BX
Telephone: +44 (0)20 8957 2200
Fax: +44 (0)20 8957 2601
WWW: http://www.bpl.co.uk
Medical Information Direct Line: +44 (0)20 8957 2622
Medical Information e-mail: medinfo@bpl.co.uk
Customer Care direct line: +44 (0)20 8957 2342
Medical Information Fax: +44 (0)20 8957 2611

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: 16/04/2012
SPC Gammaplex, a sterile liquid of 5% w/v normal immunoglobulin

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 16/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Correction of a typographical error in section 5.1
paragraph 4, line 2 currently reads "....primacy immunodeficiency diseases (PID), where Gammaplex® was infused at....."

This phrase should actually read ".....primary immunodeficiency diseases (PID), where Gammaplex® was infused at......"  [note the correct spelling of the first word, which should be primary]

In section 10 the version number has been incremented to reflect the change.  Date of revision remains unchanged at the request of MHRA.
Updated on 19/03/2012 and displayed until 16/04/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • 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 - 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-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The SmPC has been extensively rewritten to introduce the new immunomodulatory indication of ITP together with the satellite indications of Guillain Barré Syndrome and Kawasaki Disease.
 
Key points to note include:

  • Removed reference to 0-18 years throughout document
  • 4.2 added details about supervision and training for home therapy patients
  • Method of administration, removed details about 15 micron infusion set in line filter
  • 4.3 added contraindications for hereditary fructose intolerance and babies and children
  • 4.4 clarified the details about hereditary fructose intolerance.  Also added paragraph about home therapy
  • 4.8 revised tabulation of ADRs
  • 10 new date of revision of the text added (15 March 2012) and new version code added (VSS2)
Updated on 04/11/2009 and displayed until 19/03/2012
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

 
  human normal immunoglobulin