GLUCAGEN Powder and solvent for solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
GlucaGen 1 mg powder and solvent for solution for injection. GlucaGen HypoKit 1 mg powder and solvent for solution for injection.
Qualitative and quantitative composition
<u>Active substance:</u> 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 ...
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.
Therapeutic indications
Therapeutic indication GlucaGen is indicated for treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated children and adults with diabetes mellitus. Diagnostic ...
Posology and method of administration
Posology Therapeutic indication (Severe hypoglycaemia) Dosage for adult patients Administer 1 mg by subcutaneous or intramuscular injection. Special populations <u>Paediatric population (<18 years old): ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Phaeocromocytoma.
Special warnings and precautions for use
Due to the instability of GlucaGen in solution, the product should be given immediately after reconstitution and must not be given as an intravenous infusion. Therapeutic indication To prevent relapse ...
Interaction with other medicinal products and other forms of interaction
<u>Insulin:</u> Reacts antagonistically towards glucagon. <u>Indomethacin:</u> Glucagon may lose its ability to raise blood glucose or paradoxically may even produce hypoglycaemia. <u>Warfarin:</u> Glucagon ...
Fertility, pregnancy and lactation
Pregnancy Glucagon does not cross the human placenta barrier. The use of glucagon has been reported in pregnant women with diabetes and no harmful effects are known with respect to the course of pregnancy ...
Effects on ability to drive and use machines
After a severe hypoglycaemic event, the patients ability to concentrate and react may be impaired. Therefore the patient should not drive or operate machinery after a severe hypoglycaemic event until the ...
Undesirable effects
Summary of the safety profile Severe adverse reactions are very rare, although nausea, vomiting and abdominal pain may occur occasionally. Hypersensitivity reactions, including anaphylactic reactions, ...
Overdose
In the case of overdose, the patient may experience nausea and vomiting. Due to the short half life of glucagon, these symptoms will be transient. In case of dosages substantially above the approved range, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Pancreatic hormones, Glycogenolytic hormones ATC code: H04AA01 Mechanism of action Glucagon is a hyperglycaemic agent that mobilises hepatic glycogen, which is released into ...
Pharmacokinetic properties
Metabolism Glucagon is degraded enzymatically in the blood plasma and in the organs to which it is distributed. The liver and kidney are major sites of glucagon clearance, each organ contributing about ...
Preclinical safety data
No relevant pre-clinical data exist that provide information useful to the prescriber.
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. ...
Incompatibilities
There are no known incompatibilities with GlucaGen.
Shelf life
<u>GlucaGen 1 mg:</u> Prior to reconstitution, the shelf life of the product is 36 months. <u>GlucaGen HypoKit 1 mg:</u> Prior to reconstitution, the shelf life of the product is 36 months. The reconstituted ...
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. <u>GlucaGen 1 mg:</u> GlucaGen should be ...
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: Vial made of glass type I, Ph. Eur., closed with ...
Special precautions for disposal and other handling
Reconstitution GlucaGen 1 mg Draw up the water for injections (1.1 ml) in a disposable syringe. Inject the water for injections into the vial containing the glucagon compacted powder. Shake the vial gently ...
Marketing authorization holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
Marketing authorization number(s)
GlucaGen 1mg: PL 04668/0027 Diluent for GlucaGen 1mg: PL 04668/0028
Date of first authorization / renewal of the authorization
Date of first authorisation: 30 September 1991 Date of last renewal: 15 October 2006
Date of revision of the text
05/2021
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