GlucaGen HypoKit 1 mg powder and solvent for solution for injection

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

GLUCAGON

متاح من:

Novo Nordisk A/S

ATC رمز:

H04AA; H04AA01

INN (الاسم الدولي):

GLUCAGON

جرعة:

1 milligram(s)

الشكل الصيدلاني:

Powder and solvent for solution for injection

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

Glycogenolytic hormones; glucagon

الوضع إذن:

Marketed

تاريخ الترخيص:

1991-12-17

نشرة المعلومات

6
PACKAGE LEAFLET
7
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.
•
Show your family members

خصائص المنتج

Health Products Regulatory Authority
03 February 2023
CRN00CWYN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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
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 rel