Lantus 100 units/ml solution for injection in a vial

Product Information *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

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

File name

1.3.2 Mock-up PIL IE Lantus Vial -786315- PRAC SA3122-24_1597998809.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 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

File name

1.3.1 SPC Ireland Lantus -PRAC cutaneous amyloidosis (SA3122-24)_1597998726.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 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 06 July 2020

File name

1.3.2 IE Mock-up PIL Lantus Vial - 772565 PSUSA (SA1771-73)_1584970474.pdf

Reasons for updating

  • XPIL Removed

Updated on 23 March 2020

File name

1.3.1 SPC Ireland Lantus -PSUSA-00001751-201904 (SA1771-73)_1584970614.pdf

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

File name

1.3.2 IE Mock-up PIL Lantus Vial - 772565 PSUSA (SA1771-73)_1584970474.pdf

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

File name

1.3.1 SPC Ireland Lantus -PSUSA00001751201904 (SA1771-73) (2)_1582812737.pdf

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

Update of section 4.8 of the SmPC to add cutaneous amyloidosis as a new adverse drug reaction.

Updated on 11 September 2019

File name

1.3.2 Mock-up PIL-Lantus Vial[012] 544320 Ireland CP split SA1025-27_1568186477.pdf

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

File name

1.3.1 SPC Ireland Lantus Remove OptiPen-SA1099-1102_1553869866.pdf

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

File name

SPC Lantus & Lantus SoloStar 100 units-ml solution for injection vial cartridge & pre-filled pen IE .docx

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

File name

Lantus solution for injection in a vial PIL.pdf

Reasons for updating

  • New PIL for new product