Clexane 2,000 IU (20 mg) /0.2 mL Solution for Injection
- Name:
Clexane 2,000 IU (20 mg) /0.2 mL Solution for Injection
- Company:
SANOFI
- 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: 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 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 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 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 5 July 2019 SPC
Reasons for updating
- Improved presentation of SPC
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 24 January 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 24 October 2018 PIL
Reasons for updating
- XPIL Created
Updated on 6 September 2018 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 - 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
- Change to name of medicinal product
Updated on 19 June 2018 SPC
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, 20, 30, 50, 100 pre-filled syringes, and in multi-packs of 9 x 10, 100 x 10 and 200 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 7 August 2017 SPC
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 PIL
Reasons for updating
- New PIL for new product