Cyklokapron 100 mg/mL solution for injection/infusion
- Name:
Cyklokapron 100 mg/mL solution for injection/infusion
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/02/20

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Pfizer Healthcare Ireland

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 13 February 2020 PIL
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 PIL
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 SPC
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 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 23 May 2016 PIL
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 SPC
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 9 September 2014 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 28 January 2013 SPC
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 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 January 2013 SPC
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 PIL
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 SPC
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 PIL
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 SPC
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 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 2 September 2008 PIL
Reasons for updating
- Change to storage instructions
Updated on 2 September 2008 SPC
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 3 April 2008 SPC
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 1 April 2008 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 29 August 2007 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)