GlucaGen HypoKit 1mg powder and solvent for solution for injection in pre-filled syringe

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

GLUCAGON

Fáanlegur frá:

NovoNordisk A/S Novo Alle, DK – 2880 Bagsvaerd, Denmark

ATC númer:

H04AA01

INN (Alþjóðlegt nafn):

GLUCAGON

Lyfjaform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Samsetning:

GLUCAGON

Gerð lyfseðils:

POM

Lækningarsvæði:

PANCREATIC HORMONES

Leyfisstaða:

Authorised

Leyfisdagur:

2005-10-12

Upplýsingar fylgiseðill

Page 1 of 6
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
should use GlucaGen
HypoKit straight away.
Page 2 of 6
•
Show your family memb

Vara einkenni

Page 1 of 9
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
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.
Page 2 of 9
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 t