Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
GlucaGen 1 mg powder and solvent for solution for injection.
GlucaGen HypoKit 1 mg powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
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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.
| Active Ingredient |
|---|
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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 |
|---|
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Lactose monohydrate 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
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.
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
| Drug | Countries | |
|---|---|---|
| GLUCAGEN | Austria, Australia, Brazil, Cyprus, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Nigeria, Netherlands, Poland, Tunisia, United Kingdom, United States |
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