Summary of Product Characteristics
last updated on the eMC:
03/05/2012
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 03/05/2012 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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 05-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3:
severe uncontrolled hypertension
change in statement from “hypersensitivity to orgaran” to “hypersensitivity to the active substance or to any of the excipients.”
Section 4.4:
Updated information on cross-reactivity of Orgaran with the heparin-induced antibody
Cautionary statement for patients with severe hemorrhagic diathesis; renal and hepatic insufficiency; active gastric or duodenal ulceration or those undergoing a cardiopulmonary bypass procedure.
Section 4.5:
The following statement has been added:
Interaction studies have only been performed in adults.
Section 4.6:
Updated data and advice on use during pregnancy and lactation from ‘do not use’ to ‘if alternative antithrombotic treatment is unacceptable for medical reasons (e.g. HIT patients) Orgaran can be used’
Section 4.8:
Insertion of a MedDRA table and associated statements.
Section 4.9:
Change to transfusion advice from blood to fresh or frozen plasma, or if uncontrollable, plasmapheresis.
Addition of the following satatement: The effects of Orgaran on anti-Xa activity cannot be antagonized with any known agent at this time.
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Updated on 15/01/2004 and displayed until 03/05/2012
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 03/10/2003 and displayed until 15/01/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 20/05/2002 and displayed until 03/10/2003
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 05/07/2001 and displayed until 20/05/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 25/06/2001 and displayed until 05/07/2001
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/07/2001 and displayed until 25/06/2001
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Updated on 06/09/1999 and displayed until 03/07/2001
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