GLUCAGEN Powder and solvent for solution for injection Ref.[7838] Active ingredients: Glucagon

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Product name and form

GlucaGen 1 mg powder and solvent for solution for injection.

GlucaGen HypoKit 1 mg powder and solvent for solution for injection.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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.

Active Ingredient Description
Glucagon

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.

List of Excipients

Lactose monohydrate
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.

Pack sizes and marketing

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

or

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.

Marketing authorization holder

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark

Marketing authorization dates and numbers

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

Drugs

Drug Countries
GLUCAGEN Austria, Australia, Brazil, Cyprus, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, Poland, Tunisia, United Kingdom, United States

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