GlucaGen Hypokit 1mg powder and solvent for solution for injection

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Glucagon hydrochloride

Beschikbaar vanaf:

Novo Nordisk Ltd

ATC-code:

H04AA01

INN (Algemene Internationale Benaming):

Glucagon hydrochloride

Dosering:

1mg

farmaceutische vorm:

Powder and solvent for solution for injection

Toedieningsweg:

Subcutaneous; Intravenous; Intramuscular

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 06010400; GTIN: 5738019402014

Bijsluiter

GlucaGen® HypoKit 1 mg
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Glucagon
PACKAGE LEAFLET: INFORMATION FOR THE USER
GlucaGen® HypoKit 1 mg
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Glucagon
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS INJECTION
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What GlucaGen® HypoKit is and what it is used for
2. What you need to know before you use GlucaGen® HypoKit
3. How to use GlucaGen® HypoKit
4. Possible side effects
5. How to store GlucaGen® HypoKit
6. Contents of the pack and other information
7. Additional information for medical professionals
1. WHAT GLUCAGEN® HYPOKIT IS AND WHAT IT IS USED FOR
GlucaGen® HypoKit contains the active substance “glucagon”.
GlucaGen® HypoKit is for immediate, emergency use for children and
adults with diabetes
who use insulin. It is used when they have passed out (become
unconscious) because of very
low blood sugar. This is called “severe hypoglycaemia”. GlucaGen®
HypoKit is used when
they are not able to take sugar by mouth.
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. WHAT YOU NEED TO KNOW BEFORE YOU USE GLUCAGEN® HYPOKIT
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

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
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.
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
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 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.
•
_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 c