Summary of Product Characteristics
last updated on the eMC:
31/01/2008
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 31/01/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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 4.6 - 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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Contraindications (Section 4.3): Addtion of hypersensitivity to constituents and heparin-induced thrombocytopenia.
Warnings & precautions (Section 4.4): Addition of platelet count monitoring, thrombocytopenia and hypersensitivity to LMWH.
Interactions (Section 4.5): Advice concerning taking of blood samples for laboratory analysis.
Pregnancy & lactation (Section 4.6): Addition of 'The dose of heparin used would not be expected to constitute a hazard.' and 'Heparin does not cross the placental barrier and is not excreted in breast milk.'
Driving and using machines (Section 4.7): Addition of 'Heparin has no or negligible influence on the ability to drive or use machines.'
Undesirable effects (Section 4.8): Addition of thrombocytopenia, hypersensitivity reactions and local irritation.
Overdose (Section 4.9): Addition of information on signs of overdose and action required.
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Updated on 19/03/2002 and displayed until 31/01/2008
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Reasons for adding or updating:
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Change to section 1 - trade name
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