Summary of Product Characteristics
last updated on the eMC:
26/08/2009
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 26/08/2009 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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Change to section 3 - Pharmaceutical form
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 01-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In Section 2 (Qualitative and Quantitative Composition), the statement 'Full a full list of excipients, see section 6.1' has been placed after 'Excipients: 3.6mg/ml of sodium per bag'.
In Section 3 (Pharmaceutical form), the statement 'practically free from particles' has been removed.
In Section 4.4 (Special warnings and precautions for use), A warning regarding patients on a sodium controlled diet has been added.
Section 4.8 (Undesirable effects), has been completely reformatted to MedDRA terminology and frequency.
In Section 6.3 (Shelf life), the paragraphs have been clarified to show the difference between using the product immediately and dilutions in 0.9% sodium chloride solution.
In Section 6.4 (Special precautions for storage), a statement regarding the storage of reconstituted product has been added.
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Updated on 16/05/2007 and displayed until 26/08/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 4.8 - Undesirable effects
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Updated on 06/12/2006 and displayed until 16/05/2007
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Reasons for adding or updating:
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Removal of Black Triangle
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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of black triangle.
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Updated on 13/06/2005 and displayed until 06/12/2006
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.1 - Therapeutic Indications
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 5 - Pharmacological Properties
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Change to section 6.2 - Incompatibilities
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/09/2002 and displayed until 13/06/2005
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 30/11/2001 and displayed until 24/09/2002
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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