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
Zinc
Water for injections


6.2   Incompatibilities
Substances added to NovoRapid may cause degradation of insulin aspart.
This medicinal product must not be diluted or mixed with other medicinal products, except for mixing with NPH (Neutral Protamine Hagedorn) insulin in a syringe for subcutaneous use, or with infusion fluids as described in section 4.2.

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 must be stored for a maximum of 4 weeks. Store below 30°C.

NovoRapid IL SPC FEB-2021-NOTIFICATION                                                      EMA SmpC 6.4   Special precautions for storage

For storage conditions of the medicinal product, see section 6.3.

Before opening: Store in a refrigerator (2°C - 8°C). Do not freeze.
NovoRapid vial
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze.
Keep the vial in the outer carton in order to protect from light.

NovoRapid in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37ºC. The infusion set and the infusion set insertion site should be changed at least every 3 days.

NovoRapid 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 from light.

NovoRapid 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 from light.
6.5   Nature and contents of container

NovoRapid vial
10 ml solution in vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap.

Pack size of 1 vial of 10 ml.
NovoRapid Penfill
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).

Pack size of 5 cartridges.

NovoRapid 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.
NovoRapid 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, syringes, cartridges, pre-filled pens and infusion sets must not be shared.

NovoRapid IL SPC FEB-2021-NOTIFICATION                                                         EMA SmpC The cartridge must not be refilled.

NovoRapid vial
NovoRapid may be used in an infusion pump system (CSII) as described in section 4.2. Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.


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


8. MANUFACTURER:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark