Summary of Product Characteristics
last updated on the eMC:
12/09/2011
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 12/09/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 11-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2, qualitative and quantitative composition has been revised to make the wording copliant with the core SmPC for anti-D.
See below for an example of the text
2. Qualitative and Quantitative Composition
Each vial contains 250 IU human Anti-D immunoglobulin
One ml contains 125 IU/mL human Anti-D immunoglobulin.
*100 micrograms of human anti-D immunoglobulin correspond to 500 international units (IU).
Human protein content 5 – 50 g/L of which at least 95% is IgG.
For excipients see 6.1.
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Updated on 08/01/2009 and displayed until 12/09/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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Change to section 1 -Name of the Medicinal product
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| Date of revision of text on the SPC: 01-Jan-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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iu and ml changed to IU and mL throughout
1. "250 IU, solution for injection" added
4.1 "incompatible" deleted from penultimate line, "RhD positive" added to final line
4.2 b) wording added "or a single dose of 1,500 IU at 28 weeks of gestation"
4.2 Method of administration, rewording "D-GAM® vials are for single use only"
4.4 "When medicinal products prepared ..... The specific virus inactivation process used is solvent/detergent treatment." replaced by "Standard measures to prevent ..... This also applies to unknown or emerging viruses and other pathogens."
4.8 wording added " The following side effects are known to be associated with Anti-D (the incidence has not been quantified):
4.9 2nd sentence reworded to "RhD negative patients who are given RhD positive blood or other products containing RhD positive red blood cells and receive anti-D immunoglobulin should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction."
5.2 Peak serum level extended from 3 to 4 days. Half life extended from 4 to 5 weeks
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Updated on 12/04/2006 and displayed until 08/01/2009
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Updated on 04/04/2006 and displayed until 12/04/2006
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Pending awaiting re-submission
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Updated on 03/08/2004 and displayed until 04/04/2006
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Reasons for adding or updating:
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