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

Replace UK/Ireland PIL with Ireland only PIL

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.

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).