Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Glycerol
Sodium hydroxide (for pH adjustment)
Metacresol
Hydrochloric acid (for pH adjustment)
Phenol
Disodium phosphate dihydrate
Sodium chloride
Protamine sulfate
Zinc
Water for injection

6.2   Incompatibilities
In the absence of compatibility studies, 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 4 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.

During use or when carried as a spare: Store below 30°C. Do not refrigerate.
Do not freeze. Keep the cap on FlexPen in order to protect it from light.

6.5   Nature and contents of container
3 ml suspension 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. The cartridge contains a glass ball to facilitate resuspension.

Pack size of 5 pre-filled pens.

6.6   Special precautions for disposal and other handling
After removing NovoMix 50 FlexPen from the refrigerator, it is recommended to allow NovoMix 50 FlexPen to reach room temperature before resuspending the insulin as instructed for first time use.

Do not use this medicinal product if you notice that the resuspended liquid is not uniformly white, cloudy and aqueous.
The necessity of resuspending the NovoMix 50 suspension immediately before use is to be stressed to the patient.

NovoMix 50 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 and pre-filled pens must not be shared.

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