Summary of Product Characteristics
last updated on the eMC:
09/06/2011
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 09/06/2011 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: 01-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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2. Qualitative and quantitative composition
Octaplex is presented as a powder and solvent for solution for infusion containing human prothrombin complex. Octaplex nominally contains:
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Name of ingredient
|
Octaplex
Quantity per vial
(IU)
|
Octaplex
Quantity after reconstitution with 20 ml of Water for Injections
(IU/ml)
|
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Active substances
|
|
Human coagulation factor II
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280 - 760
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14 - 38
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Human coagulation factor VII
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180 - 480
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9 - 24
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Human coagulation factor IX
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500
|
25
|
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Human coagulation factor X
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360 - 600
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18 - 30
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Further active ingredients
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Protein C
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260 - 620
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13 - 31
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Protein S
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240 - 640
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12 - 32
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Updated on 06/05/2010 and displayed until 09/06/2011
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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: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Removal of black triangle
|
|
Updated on 17/06/2009 and displayed until 06/05/2010
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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
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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