Active ingredients: Glucagon
GlucaGen 1 mg powder and solvent for solution for injection.
GlucaGen HypoKit 1 mg powder and solvent for solution for injection.
Powder and solvent for solution for injection.
Before reconstitution the compacted powder should be white or nearly white. The solvent should be clear and colourless without particles.
Active substance: Human glucagon produced in Saccharomyces cerevisiae by recombinant DNA technology.
One vial contains 1 mg glucagon as hydrochloride corresponding to 1 mg (1 IU) glucagon/ml after reconstitution.
For the full list of excipients, see section 6.1.
Glucagon is a hyperglycaemic agent that mobilises hepatic glycogen, which is released into the blood as glucose. Glucagon inhibits the tone and motility of the smooth muscle in the gastrointestinal tract.
Hydrochloric 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.
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:
Vial made of glass type I, Ph. Eur., closed with a bromobutyl disc with teflon and covered with an aluminium cap
pre-filled syringe made of glass type I, Ph. Eur., with plunger (bromobutyl rubber) and needle.
The vials are provided with a tamperproof plastic cap which must be removed before use.
Not all presentations of GlucaGen may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
GlucaGen 1mg: PL 04668/0027
Diluent for GlucaGen 1mg: PL 04668/0028
Date of first authorisation: 30 September 1991
Date of last renewal: 15 October 2006