Summary of Product Characteristics
last updated on the eMC:
24/08/2011
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 24/08/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 06-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SPC harmonised
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Updated on 30/07/2009 and displayed until 24/08/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 22-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The infusion dosage has changed from 5,000 IU to UP TO 250,000 IU OVER A PERIOD OF 90 TO 180 MINUTES.
Alternatively, an infusion of up to 250,000IU Syner-KINASE can be administered into the catheter or cannula over aperiod of 90 to 180 minutes using a solution of 1,000 to 2,500 IU/ml in sterile physiological saline.
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Updated on 22/08/2008 and displayed until 30/07/2009
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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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 2 - Qualitative and quantitative composition
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Introduction of new strength
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| Date of revision of text on the SPC: 15-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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1. 10,000IU (additional dosage form)
2. 10,000IU (additional dosage form)
3. 10,000IU (additional dosage form) and MAH number
10. Revision date August 2008
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Updated on 20/12/2006 and displayed until 22/08/2008
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Reasons for adding or updating:
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