Clexane Forte 12,000 IU (120mg0/0.8ml Solution for Injection)
- Name:
Clexane Forte 12,000 IU (120mg0/0.8ml Solution for Injection)
- Company:
SANOFI
- Active Ingredients:
- Legal Category:
Product subject to restricted prescription (C)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20
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SANOFI
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 6 July 2020 PIL
Reasons for updating
- XPIL Removed
Updated on 27 May 2020
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
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 PIL
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
Reasons for updating
- Improved presentation of SmPC
Updated on 24 January 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 6 September 2018 PIL
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
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 PIL
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 SmPC for new product
Legal category: Product subject to restricted prescription (C)
Updated on 24 November 2017 SPC
Reasons for updating
- Improved presentation of SPC
Legal category: Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2017 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 28 July 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation number
Updated on 17 May 2017 SPC
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
Updated on 16 May 2017 PIL
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 SPC
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
Updated on 31 March 2015 SPC
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
Updated on 19 August 2014 SPC
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
Updated on 13 August 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 17 July 2014 SPC
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 8 January 2014 PIL
Reasons for updating
- Change of manufacturer
Updated on 7 January 2014 SPC
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
Updated on 18 December 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 19 September 2013 PIL
Reasons for updating
- Change of manufacturer
Updated on 8 January 2013 SPC
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 4 January 2013 PIL
Reasons for updating
- Change to dosage and administration
Updated on 27 November 2012 SPC
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 PIL
Reasons for updating
- Change to information about pregnancy or lactation
Updated on 29 August 2012 SPC
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
Updated on 8 March 2010 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 23 September 2009 SPC
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
Updated on 2 July 2009 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 7 April 2009 SPC
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
Updated on 13 May 2008 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to restricted prescription (C)
Updated on 5 March 2008 SPC
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
Updated on 19 November 2007 PIL
Reasons for updating
- Changes to therapeutic indications
- Change to name of manufacturer
Updated on 21 March 2007 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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 13 March 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 18 December 2006 PIL
Reasons for updating
- Improved electronic presentation
Updated on 4 September 2006 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to restricted prescription (C)
Updated on 21 February 2006 SPC
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 8 February 2006 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to restricted prescription (C)
Updated on 24 June 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 16 March 2005 PIL
Reasons for updating
- Change of manufacturer
Updated on 19 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie