Clexane Forte 12,000 IU (120mg0/0.8ml Solution for Injection)

Product Information *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to restricted prescription (C)

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 18 February 2021

File name

clexane pl medicines 795296 new_1613658780.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 06 July 2020

File name

1.3.1 Clexane patient leaflet 770581-WS100_1590576732.pdf

Reasons for updating

  • XPIL Removed

Updated on 27 May 2020

File name

1.3.1 SPC Clexane Forte 12,000 IU IE1091_1590576777.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 restricted prescription (C)

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_1590576732.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 12 August 2019

File name

Clexane Forte 12,000 IU (120 mg) 0.8 mL Solution for Injection in pre-filled syringes SPC_1565611710.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to restricted prescription (C)

Updated on 24 January 2019

File name

PIL clexane dividella_1548344607.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 06 September 2018

File name

1.3.2.1 Clexane Forte_1536246399.pdf

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)
  • 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 section 6 - date of revision

Updated on 19 June 2018

File name

Clexane Forte 12,000 IU (120 mg) 0.8 mL 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 restricted prescription (C)

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, 20, 30, 50 pre-filled syringes and in multi-packs of 3 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 24 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

Updated on 24 November 2017

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

SPC name change Clexane Forte 12,000 IU (120mg0/0.8ml Solution for Injection

Updated on 23 August 2017

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company



6.5      - reference to 0/8ml and 1ml are removed in section 6.5.

 

 

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 17 May 2017

Reasons for updating

  • Change due to harmonisation of SPC

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type IAIN Art 30

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 14 October 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Deletion of 90mg strength from product licence

Updated on 31 March 2015

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Only typographical errors corrected in updated sections.

Updated on 19 August 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.2 updated with dosage charts

Updated on 13 August 2014

Reasons for updating

  • Change to side-effects

Updated on 17 July 2014

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 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type II.C.I.4 variation application to update safety information presented in sections 4.2 and 4.4of the SPC in line with current safety data presented in our Company Core Safety Data Sheet, version 12.  The changes relate to concurrent use with spinal/epidural anaesthesia.

Updated on 08 January 2014

Reasons for updating

  • Change of manufacturer

Updated on 07 January 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type II.C.I.4 variation to update safety information presented in sections 4.4 and 4.8 of the SPC in line with current safety data presented in our Company Core Safety Data Sheets, version 10 & 11.

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 08 January 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type 1AIN B.II.e.6 Change in any part of the (primary) packaging material not in contact with the finished product formulation relating to below mentioned products.

Updated on 04 January 2013

Reasons for updating

  • Change to dosage and administration

Updated on 27 November 2012

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Type II variation related to significant modifications of the SPC due in particular to new quality, pre-clinical, clinical or phramacovigilance data.

Updated on 20 November 2012

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 29 August 2012

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Updates to section 5.1, 7 and 10

Updated on 08 March 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 23 September 2009

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Correction of typing errors.

Updated on 02 July 2009

Reasons for updating

  • Change to MA holder contact details

Updated on 07 April 2009

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update section 4.3, 4.4, 4.5, 4.8, 4.9 of SPC

Updated on 13 May 2008

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to restricted prescription (C)

Updated on 05 March 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update Section 4.8 Undesirable Effects and 10 Date of Revision

Updated on 19 November 2007

Reasons for updating

  • Changes to therapeutic indications
  • Change to name of manufacturer

Updated on 21 March 2007

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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update
Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Section 10 - Date of Revision

Updated on 13 March 2007

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 04 September 2006

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to restricted prescription (C)

Updated on 21 February 2006

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 08 February 2006

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to restricted prescription (C)

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