Glucagen Hypokit

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Glucagon hydrochloride 1mg (recombinant);  ;  

Disponible desde:

Novo Nordisk Pharmaceuticals Ltd

Designación común internacional (DCI):

Glucagon hydrochloride 1 mg (recombinant)

Dosis:

1 mg

formulario farmacéutico:

Solution for injection

Composición:

Active: Glucagon hydrochloride 1mg (recombinant)     Excipient: Lactose monohydrate Water for injection

Unidades en paquete:

Combination pack, powder+diluent in plastic box, 1 dose unit

clase:

Restricted

tipo de receta:

Restricted

Fabricado por:

Novo Nordisk A/S

indicaciones terapéuticas:

Therapeutic Treatment of severe hypoglycaemic reactions, which may occur in the management of diabetic patients receiving insulin or oral hypoglycaemic agents. To prevent the occurrence of secondary hypoglycaemia, oral carbohydrate should be given to restore the hepatic glycogen when the patient has responded to the treatment. The mechanism and hence treatment of sulfonylurea-induced hypoglycaemia differs from that of severe insulin-induced hypoglycaemia in some important ways. Consciousness should preferably be restored by the administration of intravenous glucose. If glucagon is used due to the unavailability of intravenous glucose (e.g. before reaching a hospital) care should be taken to protect against secondary hypoglycaemia with constant monitoring of the patient's blood sugar level by medical personnel. Subsequent administration of intravenous glucose may be required.

Resumen del producto:

Package - Contents - Shelf Life: Combination pack, powder+diluent in plastic box - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Syringe, Diluent - 1 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, - 1 mg - 36 months from date of manufacture stored at or below 25°C

Fecha de autorización:

1989-09-18

Información para el usuario

GlucaGen® HypoKit
1
GLUCAGEN® HYPOKIT
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GLUCAGEN® HYPOKIT?
GlucaGen® HypoKit contains the active ingredient glucagon
hydrochloride. GlucaGen® HypoKit is used to treat severe
hypoglycaemia (extremely low blood sugar levels, or a “hypo”) in
people using insulin or taking tablets to control their
diabetes, who have become unconscious.
For more information, see Section 1. Why am I using GlucaGen®
HypoKit?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GLUCAGEN® HYPOKIT?
Do not use if you have ever had an allergic reaction to GlucaGen®
HypoKit or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR FAST.
For more information, see Section 2. What should I know before I use
GlucaGen® HypoKit?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GlucaGen® HypoKit and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE GLUCAGEN® HYPOKIT?
The freeze-dried GlucaGen® powder should be dissolved in the water
provided and then injected under the skin, into a muscle.
More instructions can be found in Section 4. How do I use GlucaGen®
HypoKit? and 8. Instructions for use
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GLUCAGEN® HYPOKIT?
THINGS YOU
SHOULD DO
•
Tell any doctor or pharmacist you visit that you keep a GlucaGen®
HypoKit.
•
Check the expiry date printed on the pack. If your medicine has passed
this date, do not use it.
THINGS YOU
SHOULD NOT DO
•
Use the medicine if: it does not look like a powder or powdery tablet
before adding the water; the
powder does not dissolve properly after adding the water; the solution
looks like a gel.
DRIVING OR USING
MACHINES
•
If you are still experiencing the

Ficha técnica

2
NEW ZEALAND DATASHEET
1 PRODUCT NAME
GlucaGen
®
HypoKit
, powder and solvent for solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucagon (rys) 1 mg/ml as hydrochloride, produced by genetic
engineering from yeast
(_Saccharomyces cerevisiae_). For full list of excipients see section
6.1.
3 PHARMACEUTICAL FORM
White crystalline powder (which may appear more like a powdery tablet
upon settling) and
clear colourless solvent for solution for injection. After
reconstitution of glucagon with the
solvent (Sterilised Water for Injections), each syringe contains
glucagon 1 mg/ml.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
_Therapeutic _
Treatment of severe hypoglycaemic reactions, which may occur in the
management of
diabetic patients receiving insulin or oral hypoglycaemic agents.
To prevent the occurrence of secondary hypoglycaemia, oral
carbohydrate should be given
to restore the hepatic glycogen when the patient has responded to the
treatment.
The mechanism and hence treatment of sulfonylurea-induced
hypoglycaemia differs from
that of severe insulin-induced hypoglycaemia in some important ways.
Consciousness
should preferably be restored by the administration of intravenous
glucose. If glucagon is
used due to the unavailability of intravenous glucose (e.g. before
reaching a hospital) care
should be taken to protect against secondary hypoglycaemia with
constant monitoring of the
patient’s blood sugar level by medical personnel. Subsequent
administration of intravenous
glucose may be required.
_ _
_Diagnostic _
Motility inhibitor in examinations of the gastrointestinal tract in
adults, e.g. double contrast
radiography and endoscopy.
4.2
Dose and method of administration
Before reconstitution the powder should be a white or nearly white
powder (which may
appear more like a powdery tablet upon settling). The solvent should
be clear and colourless
without particles.
The freeze dried glucagon should be dissolved in the accompanying
diluent. Inject the water
for injections (1.1 mL) into the via