Lantus 100 units/ml solution for injection in a vial
- Name:
Lantus 100 units/ml solution for injection in a vial
- 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: 21/08/20
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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 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 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 not be renewed (A)
Updated on 6 July 2020 PIL
Reasons for updating
- XPIL Removed
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 not be renewed (A)
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 27 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
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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 29 March 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
- OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO which all deliver Lantus in 1 unit dose increments.
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 29 May 2018 PIL
Reasons for updating
- New PIL for new product