Clexane 10,000 IU (100mg)/1ml Solution for Injection *

  • Company:

    SANOFI
  • Status:

    Updated
  • Legal 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

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 12 October 2021

File name

1.3.1 SPC Clexane 10,000 IU_1634037355.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 12 October 2021

File name

1.3.1 Clexane Patient Leaflet_1634037300.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for

Updated on 27 May 2020

File name

1.3.1 SPC Clexane 10,000 IU IE1092_1590576550.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
  • 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

Sections 4.2, 4.4, 6.3 & 10 have been updated.

Updated on 27 May 2020

File name

1.3.1 Clexane patient leaflet 770581-WS100_1590576502.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 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 July 2019

File name

Clexane 10,000 IU (100mg)1ml Solution for Injection in pre-filled syringes SPC_1562327058.pdf

Reasons for updating

  • 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

Updated to PDF

Updated on 24 January 2019

File name

PIL clexane dividella_1548337140.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 06 September 2018

File name

Clexane all strengths PIL.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to name of medicinal product

Updated on 19 June 2018

File name

Clexane 10,000 IU (100mg)1ml Solution for Injection in pre-filled syringes SPC.docx

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

 

 

Section 1 added:-

In pre-filled syringes

Section 3 wording replaced with

Solution for injection in pre-filled syringes.

Clear, colourless to yellowish solution, pH value 5.5-7.5.

Section 4.2 removed:-

Note for the pre-filled syringes fitted with an automatic safety system: injection. (see instructions in section 6.6).

Section 4.8 formatting in section:- Blood and the lymphatic system disorders and Skin and subcutaneous tissue disorders

Section 6.2 wording replaced with:-

This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.

Section 6.4 refrigerate removed

Section 6.5 wording replaced with:-

Solution for injection in pre-filled syringes (type I glass) fitted with rubber stopper (chlorobutyl and bromobutyl) and injection needle (with automatic safety system ERIS™ or PREVENTIS™ or without an automatic safety system).

Supplied in packs of 2, 5, 6, 10, 12, 20, 24, 30, 50, 100 pre-filled syringes and in multi-packs of 3 x 10 and 9 x 10 pre-filled syringes.

Section 6.6 wording replaced with:-

Pre-filled syringes are ready for immediate use. For method of administration see section 4.2.

Use only clear, colourless to yellowish solutions.

Pre-filled syringes are supplied with or without an automatic safety system. The instructions for use are presented in the package leaflet.

Each syringe is for single use only 

Updated on 19 June 2018

File name

Clexane all strengths PIL.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 23 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 28 July 2017

File name

PIL_8364_792.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 2017

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 16 May 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 August 2014

Reasons for updating

  • Change to side-effects

Updated on 08 January 2014

Reasons for updating

  • Change of manufacturer

Updated on 18 December 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 19 September 2013

Reasons for updating

  • Change of manufacturer

Updated on 04 January 2013

Reasons for updating

  • Change to dosage and administration

Updated on 20 November 2012

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 08 March 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 02 July 2009

Reasons for updating

  • Change to MA holder contact details

Updated on 19 November 2007

Reasons for updating

  • Changes to therapeutic indications
  • Change to name of manufacturer

Updated on 13 March 2007

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 24 June 2005

Reasons for updating

  • Improved electronic presentation

Updated on 16 March 2005

Reasons for updating

  • Change of manufacturer

Updated on 19 August 2004

Reasons for updating

  • New PIL for medicines.ie