Summary of Product Characteristics
last updated on the eMC:
01/02/2011
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 01/02/2011 and displayed until Current
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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: 10-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Underlined text has been added, text with strike through deleted:
4.8 Undesirable effects
There are only few unconfirmed reports on the occurrence of possible anaphylactoid reactions after IV injection of Konakion MM. There have been reports of anaphylactoid reactions after intravenous injections of Konakion MM. Local irritation may occur at the injection site but is unlikely due to the small injection volume. Rarely, injection site reactions may occur which may be severe, including inflammation, atrophy and necrosis.
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Updated on 25/02/2010 and displayed until 01/02/2011
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 11-Mar-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| renewal date updated
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Updated on 19/07/2007 and displayed until 25/02/2010
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Text underlined has been added, text with strike through deleted:
4.9 Overdose
No overdose effects are known.
There is no known clinical syndrome attributable to hypervitaminosis of vitamin K1.
The following adverse events have been reported concerning overdose with use of Konakion in neonates and infants: jaundice, hyperbilirubinaemia, increase GOT and GGT, abdominal pain, constipation, soft stools, malaise, agitation and cutaneous eruption. The causality of those cannot be established. The majority of these adverse events were considered non-serious and resolved without any treatment.
Treatment of suspected overdose should be aimed at alleviating symptoms.
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Updated on 07/03/2006 and displayed until 19/07/2007
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Addition of Black Triangle
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Updated on 17/01/2006 and displayed until 07/03/2006
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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 5.2 - Pharmacokinetic Properties
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Change to section 6.2 - Incompatibilities
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 06/11/2001 and displayed until 17/01/2006
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Correction of spelling/typing errors
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Updated on 14/08/2001 and displayed until 06/11/2001
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 14/08/2001
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