Lantus 100 units/ml solution for injection in a cartridge
- Name:
Lantus 100 units/ml solution for injection in a cartridge
- Company:
SANOFI
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/01/21

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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 12 January 2021 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 21 August 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 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 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 21 August 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 23 March 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 23 March 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 18 February 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update of section 4.8 of the SmPC to add cutaneous amyloidosis as a new adverse drug reaction. |
Updated on 6 February 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update of section 4.8 of the SmPC to add cutaneous amyloidosis as a new adverse drug reaction.
Updated on 11 September 2019 PIL
Reasons for updating
- Joint PIL superseded by individual PILs
Free text change information supplied by the pharmaceutical company
Replace UK/Ireland PIL with Ireland only PIL
Updated on 1 April 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
Updated on 27 February 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Pens to be used with Lantus 100 units/ml in cartridges
Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used. The Lantus cartridges should only be used with the following pens:
- JuniorSTAR which delivers Lantus in 0.5 unit dose increments
- OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO which all deliver Lantus in 1 unit dose increments.
These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Not all of these pens may be marketed in your country (see section 4.2 and 6.6)
Lantus 100 units/ml solution for injection in a cartridge
Insulin pen
Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used. The Lantus cartridges are to be used only in conjunction with the pens: OptiPen, ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO or JuniorSTAR (see section 4.2 and 4.4). Not all of these pens may be marketed in your country.
The pen should be used as recommended in the information provided by the device manufacturer.
The manufacturer’s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Updated on 29 May 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
Updated on 6 April 2018 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 Qualitative and Quantitative Composition added and wording amended:-
· Lantus 100 units/ml solution for injection in a vial
· Lantus 100 units/ml solution for injection in a cartridge, Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen
Section 4.2 Posology and method of administration
Added under sub heading Method of administration :-
· Lantus 100 units/ml solution for injection in a Vial
· Cartridge deleted.
· Lantus 100 units/ml solution for injection in a cartridge
· Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used (see section 4.4).
· For further details on handling, see section 6.6.
·
· Lantus 100 units/ml solution for injection in a
· Lantus SoloStar 100 units/ml in pre filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see section 4.4).
Section 4.4 Special warnings and precautions for use
Added under Pens to be used with Lantus
· 100 units/ml in cartridges
· Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used.
· (see section 4.2 and 6.6)
Added under Handling of the SoloStar pre-filled pen
· Lantus SoloStar 100 units/ml in pre filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see section 4.2).
Section 6.2 Incompatibilities added:-
· Lantus 100 units/ml solution for injection in a vial
· Cartridge deleted
Section 6.3 Shelf-life added added and wording amended:-
· Lantus 100 units/ml solution for injection in a vial
· Lantus 100 units/ml solution for injection in a cartridge, Lantus SoloStar 100 units/ml solution for injection in a
Section 6.5 Nature and contents of container added:-
· Lantus 100 units/ml solution for injection in a Vial
· 5 ml vial
· 10 ml vial
· Lantus 100 units/ml solution for injection in a cartridge,
· Deleted:- SoloStar pre filled pen
· Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges.
· Not all pack sizes may be marketed
· Lantus SoloStar 100 units/ml solution for injection in a pre filled pen
· Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber) containing 3 ml of solution.
· Deleted:- SoloStar pre-filled pen
· Pack size
· Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges.
Section 6.6 Special precautions for disposal and other handling added:-
Under Insulin pen:-
· 100 units/ml solution for injection
· Lantus 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used.
· 4.2 and
· Deleted: If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/ml) and injected.
Under Cartridge added:-
· SoloStar 100 units/ml solution for injection in a
· Lantus SoloStar 100 units/ml in pre filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see section 4.2 and 4.4).
Updated on 6 April 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 26 June 2017 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 26 June 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 February 2017 SPC
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 December 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 21 December 2016 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 14 October 2015 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to storage instructions
- Change to date of revision
Updated on 16 July 2015 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 24 September 2014 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 30 April 2014 PIL
Reasons for updating
- Change to further information section
Updated on 16 January 2014 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 12 November 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 2 August 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to marketing authorisation holder
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 18 August 2010 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 22 January 2010 PIL
Reasons for updating
- Change to further information section
Updated on 21 August 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 4 March 2008 PIL
Reasons for updating
- New PIL for medicines.ie