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Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/02/2011
SPC Cyklokapron Injection

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 23/02/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 (Posology and method of administration) – Paediatric prescribing information has been added/updated.
Section 4.3 (Contraindications) – Contraindications have been added.
Section 4.4 (Special warnings and precautions for use) – Warnings have been added/updated.
Section 4.8 (Undesirable effects) – Undesirable effects have been added and ordered by system/organ class.
Section 5.1 (Pharmacodynamic properties) – Paediatric information has been added.
Section 5.2 (Pharmacokinetic properties)
Updated on 23/10/2009 and displayed until 23/02/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8 has been revised to include the following information: ‘Nervous System Disorders: dizziness, convulsions’
Updated on 15/01/2008 and displayed until 23/10/2009
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 19/12/2007 and displayed until 15/01/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7: Revision of MAH address to the following:

 

Pharmacia Ireland Ltd.,

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24
Updated on 23/10/2007 and displayed until 19/12/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 – Change from Plasminogen to fibrinolysin

 

Section 5.1 – Change from Plasminogen to fibrinolysin

 

Section 7 – MA Holder address amended from Milton Keynes to Sandwich

Updated on 04/09/2007 and displayed until 23/10/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 – Change from Plasminogen to fibrinolysin

 

Section 5.1 – Change from Plasminogen to fibrinolysin

 

Section 6.2 – Change from Plasminogen to fibrinolysin
Updated on 10/08/2007 and displayed until 04/09/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 – Change from Plasminogen to fibrinolysin

 

Section 5.1 – Change from Plasminogen to fibrinolysin

 

Section 7 – MA Holder address amended from Milton Keynes to Sandwich

Updated on 11/12/2001 and displayed until 10/08/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
  • Correction of spelling/typing errors
Updated on 11/12/2001 and displayed until 11/12/2001
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/07/2001 and displayed until 11/12/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 06/09/1999 and displayed until 13/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  tranexamic acid