Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1      List of excipients
Glycerin
Metacresol
Zinc oxide
Hydrochloric acid solution 10 % (for pH adjustment)
Sodium Hydroxide solution 10 % (for pH adjustment)
Water for injection

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

6.3      Shelf life
The expiry date of the product is indicated on the packaging material.
Shelf life after first use

The medicinal product may be stored for a maximum of 28 days up to 30°C and away from direct heat or direct light. The pen 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

Before use
Store in a refrigerator (2°C - 8°C).

Do not freeze.

Do not store Basaglar next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.

In use

For storage conditions after first opening of this medicinal product, see section 6.3.

6.5      Nature and contents of container

3 mL solution in a cartridge (type 1 colorless glass) with a plunger (chlorobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutyl or chlorobutyl rubber) with aluminium seal.


The cartridge is sealed in a disposable pen injector.
Pack sizes
Packs of 1, 2, 5 and 10 pre-filled pens or cartridges.

Not all pack sizes may be marketed.

Needles are not included in the pack.
6.6     Special precautions for disposal and other handling

Inspect Basaglar before use. It must only be used if the solution is clear, colorless, with no solid particles visible, and if it is of water-like consistency. Since Basaglar is a solution, it does not require re-suspension before use.
Basaglar 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).

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.