GLUCAGEN HYPOKIT 1 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

GLUCAGON AS HYDROCHLORIDE

Commercializzato da:

NOVO NORDISK LTD., ISRAEL

Codice ATC:

H04AA01

Forma farmaceutica:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composizione:

GLUCAGON AS HYDROCHLORIDE 1 MG

Via di somministrazione:

S.C, I.M

Tipo di ricetta:

Required

Prodotto da:

NOVO NORDISK A/S, DENMARK

Gruppo terapeutico:

GLUCAGON

Area terapeutica:

GLUCAGON

Indicazioni terapeutiche:

Treatment of severe hypoglycaemia reactions which may occur in the management of insulin treated persons with diabetes.

Data dell'autorizzazione:

2020-12-31

Foglio illustrativo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
GLUCAGEN
® HYPOKIT
® 1 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ACTIVE INGREDIENT:
glucagon 1 mg (as hydrochloride)
INACTIVE INGREDIENTS AND ALLERGENS IN THIS MEDICINE: See section 6
‘Additional
information’. Also see section 2 under ‘Important information
about some of this medicine’s
ingredients’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
GlucaGen HypoKit is used for the treatment of severe hypoglycaemia
reactions which may occur
in patients with diabetes
who are treated with insulin.
GlucaGen HypoKit is intended for immediate, emergency use in children
and adults with diabetes
who use insulin. It is for use when these patients have passed out
(become unconscious)
because of very low blood sugar level.
This effect is called “severe hypoglycaemia”. GlucaGen HypoKit is
used when the patients are not
able to take sugar by mouth.
THERAPEUTIC GROUP: pancreatic hormones, glycogenolytic hormones.
GlucaGen HypoKit contains the active ingredient “glucagon”.
Glucagon is a natural hormone
which has the opposite effect of insulin in the human body. It helps
the liver to change something
called “glycogen” into glucose (sugar). Glucose is then released
into the blood stream – this
makes the blood sugar level rise.
FOR MEDICAL PROFESSIONALS: See section 7.
2.
BEFORE USING THIS MEDICINE
IMPORTANT INFORMATION
•
Make sure that your family members, people you work with or close
friends know about
GlucaGen HypoKit. Tell them that if you pass out (become unconscious)
they should use
GlucaGen

Scheda tecnica

_ _
1.
NAME OF THE MEDICINAL PRODUCT
GlucaGen
®
HypoKit 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
THERAPEUTIC INDICATIONS
Treatment of severe hypoglycaemic reactions, which may occur in the
management of insulin treated
persons with diabetes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ _
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 6–8 years) or
1 mg (children above 25 kg or older than 6–8 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.
METHOD OF ADMINISTRATION
Dissolve the compacted powder in the accompanying solvent, as
described in section 6.6.
_ _
Administer by subcutaneous or intramuscular injection. The patient
will normally respond within
10 minutes. When the patient has responded to the treatment, give oral
carbohydrate to restore the liver
glycogen and prevent relapse of hypoglycaemia. If the patient does not
respond within 10 minutes,
intravenous glucose should be given.
GlucaGen HypoKit IL SPC MAR 2023-Notification
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Phaeocr