Cyklokapron 100 mg/mL solution for injection/infusion
*Company:
Pfizer Healthcare IrelandStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 04 April 2024
File name
Reg PIL CK 17-0 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 10 August 2023
File name
RegSPCCK141IEclean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 August 2023
File name
RegSPCCK141IEclean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 August 2023
File name
RegSPCCK141IEclean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.4:
Updated haematuria warning.
Updated on 13 February 2023
File name
DEC201919045_Reg SPC CK 11_2 IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 February 2020
File name
DEC202009383_Reg PIL CK 14_1 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 11 April 2019
File name
DEC201919045_Reg PIL CK 13_1 IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 11 April 2019
File name
DEC201919045_Reg SPC CK 11_2 IE clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Update to Sections 1, 3, 4.1, 4.2, 4.3, 4.4, 4.6, 4.8, 5.2, 6.1, 6.2, 6.3 & 6.6 to correct minor inconsistencies in the naming of the pharmaceutical form to EDQM standard terms and to update in line with QRD template
Updated on 27 May 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 May 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated in in section 2, 3, 4.2, 4.3, 4.4, 4.6, 4.8, 5.2, 6.2, 6.3, 6.4, 6.5 & 6.6
Updated on 23 May 2016
File name
PIL_13031_369.pdf
Reasons for updating
- New PIL for new product
Updated on 23 May 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to how the medicine works
- Change to further information section
- Change to date of revision
Updated on 16 September 2014
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 09 September 2014
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 28 January 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 7-Marketing authorisation holder: updated to include Pfizer Healthcare Ireland name
Section 8-Marketing authorisation number: updated to include new Product license number
Updated on 24 January 2013
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 January 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1 Therapeutic Indications
Section 4.2 Posology and method of administration
Section 4.3 Contra-indications
Section 4.4 Special warnings and precautions for use
Section 4.5 Interactions with other medicinal products and other forms of interaction
Section 4.6 Fertility, pregnancy and lactation
Section 4.7 Effects on ability to drive and use machines
Section 4.8 Undesirable effects
Section 4.9 Overdose
Section 5.1 Pharmacodynamics properties
Section 5.2 Pharmacokinetic properties
Section 5.3 Preclinical Safety Data
Updated on 11 January 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to dosage and administration
Updated on 24 July 2012
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 4.1 - Therapeutic indications
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.6 Fertility, pregnancy and lactation
4.7 Effects on ablility to drive and use machines
4.8 Undesirable effects
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical Safety data
Updated on 19 July 2012
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 20 October 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 October 2011
Reasons for updating
- Change to name of manufacturer
Updated on 02 September 2008
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
'For storage of the diluted medicinal product see section 6.3'
Updated on 02 September 2008
Reasons for updating
- Change to storage instructions
Updated on 03 April 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
7. NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER
Pharmacia Ireland Ltd.,
9 Riverwalk
Citywest Business Campus
Updated on 01 April 2008
Reasons for updating
- New PIL for medicines.ie
Updated on 29 August 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)