Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS


GlucaGen HypoKit IL SPC MAR 2023-Notification
6.1    List of excipients
Lactose monohydrateHydrochloric acid for pH adjustment
Sodium hydroxide for pH adjustment
Water for injections

The reconstituted solution contains glucagon 1 mg/ml and lactose monohydrate 107 mg/ml.

6.2    Incompatibilities
There are no known incompatibilities with GlucaGen.

6.3    Shelf life

GlucaGen HypoKit 1 mg:
The expiry date of the product is indicated on the packaging materials 
The reconstituted GlucaGen should be used immediately after preparation.

6.4    Special precautions for storage
Do not freeze.

If, in rare cases, the reconstituted product shows any signs of fibril formation (viscous appearance) or insoluble matter, it should be discarded.

GlucaGen HypoKit 1 mg:
The user can store GlucaGen HypoKit at a temperature below 25ºC provided that the expiry date is not exceeded. Store in the original package in order to protect from light.

6.5    Nature and contents of container

Container for GlucaGen:
Vial made of glass type I, Ph. Eur., closed with a bromobutyl stopper and covered with an aluminium cap.

Containers for solvent:

Pre-filled syringe made of glass type I, Ph. Eur., with plunger (bromobutyl rubber) and needle.
The vial is provided with a tamperproof plastic cap which must be removed before use.

Not all presentations of GlucaGen may be marketed.

6.6    Special precautions for disposal
Reconstitution

GlucaGen HypoKit 1 mg:
Inject the water for injections (1.1 ml) into the vial containing the glucagon compacted powder. Shake the vial gently until the glucagon is completely dissolved and the solution is clear. Withdraw the solution back into the syringe.

The reconstituted solution appears clear and colourless and forms an injection of 1 mg (1 IU) per ml to be administered subcutaneously or intramuscularly.


GlucaGen HypoKit IL SPC MAR 2023-Notification
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. REGISTRATION HOLDER:

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