GLUCAGEN FOR INJECTION 1 mgml

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Glucagon (as hydrochloride)

Beschikbaar vanaf:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC-code:

H04AA01

Dosering:

1mg/ml

farmaceutische vorm:

INJECTION, POWDER, FOR SOLUTION

Samenstelling:

Glucagon (as hydrochloride) 1mg/ml

Toedieningsweg:

INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR

Prescription-type:

Prescription Only

Geproduceerd door:

Novo Nordisk A/S

Autorisatie-status:

ACTIVE

Autorisatie datum:

1996-12-09

Bijsluiter

GlucaGen
®
1mg Vial site DK Professional Leaflet STF 2015 Based on
8-9401-00-010-1
1
GLUCAGEN
® 1 MG
Powder and solvent for solution for injection
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
_List of excipients_
.
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.
CLINICAL PARTICULARS
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 INDICATION
GlucaGen
®
is indicated for motility inhibition in examinations of the
gastrointestinal tract in adults.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY

_THERAPEUTIC INDICATION (SEVERE HYPOGLYCAEMIA)_
Dosage for adult patients: Administer 1 mg by subcutaneous or
intramuscular injection.
SPECIAL POPULATIONS
_Paediatric population (< 18 years old):_
GlucaGen
®
can be used for the treatment of severe
hypoglycaemia in children and adolescents.
Dosage for paediatric patients:

Children below 25 kg or younger than 6-8 years: Administer 0.5 mg.

Children above 25 kg or older than 6-8 years: Administer 1.0 mg.
_Elderly (≥ 65 years old):_
GlucaGen
®
can be used in elderly patients.
_Renal and hepatic impairment:_
GlucaGen
®
can be used in patients with renal and hepatic impairment.
GlucaGen
®
1mg Vial site DK Professional Leaflet STF 2015 Based on
8-9401-00-010-1
2

_DIAGNOSTIC INDICATION (INHIBITION OF GASTROINTESTINAL MOTILITY)_
Dosage for adult patients: The diagnostic dose for relaxation of the
stomach, duodenal bulb,
duodenum and small bowel is 0.2–0.5 mg given as intravenous
injection or 1 mg g

Productkenmerken

1 of 8
1.
Name of the medicinal product
GlucaGen
®
1 mg
Powder and solvent for solution for injection
2.
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.
3.
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.
4.
Clinical particulars
4.1
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 indication
GlucaGen
®
is indicated for motility inhibition in examinations of the
gastrointestinal tract in adults.
4.2
Posology and method of administration
Posology
•
Therapeutic indication (Severe hypoglycaemia)
Dosage for adult patients: Administer 1 mg by subcutaneous or
intramuscular injection.
Special populations
Paediatric population (< 18 years old): GlucaGen
®
can be used for the treatment of severe hypoglycaemia in
children and adolescents.
Dosage for paediatric patients: Administer 0.5 mg (children below 25
kg or younger than 8 years) or 1 mg
(children above 25 kg or older than 8 years).
Elderly (≥ 65 years old): GlucaGen
®
can be used in elderly patients.
Renal and hepatic impairment: GlucaGen
®
can be used in patients with renal and hepatic impairment.
•
Diagnostic indication (Inhibition of gastrointestinal motility)
Dosage for adult patients: The diagnostic dose for relaxation of the
stomach, duodenal bulb, duodenum and
small bowel is 0.2–0.5 mg given as intravenous injection or 1 mg
given intramuscularly; the dose to relax the
colon is 0.5–0.75 mg intravenously or 1–2 mg intramuscularly.
2 of 8
Special populations
Paediatric population