Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Glycerol
Metacresol
Phenol
Sodium chloride
Disodium phosphate, dihydrate
Zinc
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections

6.2   Incompatibilities
Substances added to Levemir may cause degradation of insulin detemir, e.g. if the medicinal product contains thiols or sulphites. Levemir should not be added to infusion fluids.
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 materials.
During use or when carried as a spare: The product can be stored for a maximum of 6 weeks.

6.4    Special precautions for storage

Before opening: Store in a refrigerator (2°C–8°C). Keep away from the cooling element. Do not freeze.

Levemir Penfill
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze.
Keep the cartridge in the outer carton in order to protect it from light.

Levemir FlexPen
During use or when carried as a spare: Store below 30°C. Can be stored in a refrigerator (2°C–8°C).
Do not freeze.
Keep the pen cap on the pen in order to protect it from light.
6.5    Nature and contents of container

Levemir Penfill
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).

Pack size of 5 cartridges.

Levemir FlexPen
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.

Pack sizes of 1 (with needles) and 5 (without needles) pre-filled pens.
Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling

Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.

Levemir which has been frozen must not be used.
The patient should be advised to discard the needle after each injection.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Needles, cartridges and pre-filled pens must not be shared.

The cartridge must not be refilled.
7.    REGISTRATIN HOLDER

Novo Nordisk Ltd.,
1 Atir Yeda St.
Kfar-Saba 4464301, Israel