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Cyklokapron 100 mg/mL solution for injection/infusion

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Pharmacy Only: Prescription

Updated on 26 November 2024

File name

Reg PIL CK 23_1 IE - clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 26 November 2024

File name

Reg SPC CK 19_1 IE - clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Correction of spelling/typing errors
  • Improved presentation of SPC

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 2

Addition of wording: Each 1 mL contains 100 mg tranexamic acid.

 Section 4.4 & 4.5

Updated wording from oral to hormonal contraceptive.

Minor typos and formatting corrected throughout SPC.

 


Updated on 16 October 2024

File name

Reg SPC CK 18_0 IE - clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 16 October 2024

File name

Reg PIL CK 22_0 IE - clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 19 August 2024

File name

Reg SPC CK 17_0 IE - clean.pdf

Reasons for updating

  • 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 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

The SPC has been updated as follows: 

 

• Sections 4.2 Posology and method of administration, 4.3 Contraindications, and 4.4 Special warnings and precautions for use, to add warning statements against the administration of tranexamic acid via intrathecal and epidural routes.

• Sections 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, and 4.6 Fertility, pregnancy and lactation, to update information on hormonal contraceptives, pregnancy and lactation.

• Section 5.3 Preclinical safety data, to include additional information on the effects of tranexamic acid in animals.

 


Updated on 19 August 2024

File name

Reg PIL CK 21_0 IE - clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

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

SPC All sections – Formatting changes were made throughout the PIL in line with QRD v9

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

4.1 Therapeutic indications updated

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

SmPC - changes to section 7 & 10

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

Section 6.4 - section updated with text: 

    '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

National Digital Park

Citywest Business Campus

Dublin 24

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)