Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide, water for injections.

10 ml vial also contains polysorbate 20.

6.2    Incompatibilities
This medicinal product must not be mixed with other medicinal product.

Lantus 100 units/ml solution for injection in a vial
It is important to ensure that syringes do not contain traces of any other material.

6.3    Shelf-life
Lantus 100 units/ml solution for injection in a vial
3 years

Shelf-life after first use of the vial:
The medicinal product may be stored for a maximum of 4 weeks not above 30°C away from direct heat or direct light. Keep the vial in the outer carton in order to protect from light.

It is recommended that the date of the first use from the vial be noted on the label.

Lantus 100 units/ml solution for injection in a pre-filled pen SoloStar 3 years.

Shelf life after first use of the pen:
The medicinal product may be stored for a maximum of 4 weeks not above 30°C away from direct heat or direct light.

The pens in use must not be stored in the refrigerator.

The pen cap must be put back on the pen after each injection in order to protect from light.
6.4   Special precautions for storage

Unopened vials, not in‐use SoloStar pens
Store in a refrigerator (2°C-8°C).
Do not freeze or place next to the freezer compartment or a freezer pack.
Keep the vial or SoloStar per-filled pen in the outer carton in order to protect from light.

Opened vials or SoloStar pens
For storage conditions after first opening of this medicinal product, see section 6.3.


6.5 Nature and contents of container

Lantus 100 units/ml solution for injection in a vial
Type 1 colourless glass vial with a flanged cap (aluminium), a stopper (type 1, laminate of polyisoprene and bromobutyl rubber) and a tear-off cap (polypropylene) containing 10 ml of solution.
Pack of 1 vial.


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.
The cartridge is sealed in a disposable pen injector. Needles are not included in the pack.
Packs of 5 SoloStar pre-filled pens.

6.6 Special precautions for disposal and other handling

Inspect Lantus before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since Lantus is a solution, it does not require resuspension before use.
Lantus must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins (see section 4.4)


Lantus 100 units/ml solotion for injection in a pre-filled pen SoloStar 
Lantus 100 units/ml in pre-filled pen SoloStar is only suitable for subcutaneous injections.
If administration by syringe is necessary, a vial should be used (see section 4.2 and 4.4).
Before first use, the pre-filled pen must be stored at room temperature for 1 to 2 hours.
Empty pre-filled pens must never be reused and must be properly discarded.
To prevent the possible transmission of disease, each pen must be used by one patient only.
Before using the pre-filled pen , the instructions for use included in the package leaflet must be read carefully.

MANUFACTURER:
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.