GlucaGen Hypokit 1 mg powder and solvent for solution for injection

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Glucagon hydr0chloride

থেকে পাওয়া:

PCO Manufacturing Ltd.

এটিসি কোড:

H04AA01

INN (International Name):

Glucagon hydr0chloride

ডোজ:

1 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Powder and solvent for solution for injection

প্রেসক্রিপশন টাইপ:

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

Therapeutic area:

glucagon

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2014-10-10

তথ্য লিফলেট

_ _
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 onto 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 and others where you
keep

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
01 December 2019
CRN0099FT
Page 1 of 2
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.
_Product imported fromtheCzech Republic, Poland and the United
Kingdom: _Before reconstitution the powder should be white or
nearly white powder. The solvent should be clear and colourless
without particles.
4 CLINICAL PARTICULARS
As per PA0218/031/002.
5 PHARMACOLOGICAL PROPERTIES
As per PA0218/031/002.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Hydrochloric acid for pH adjustment
Sodium hydroxide for pH adjustment
Water for injections
The reconstituted solution contains glucagon 1 mg/ml and lactose
monohydrate 107 mg/ml.
6.2 INCOMPATIBILITIES
There are no known incompatibilities with GlucaGen.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
The reconstituted GlucaGen should be used immediately after
preparation.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
GlucaGen HypoKit should be stored at a temperature of 2-8°C (in a
refrigerator). The user can store GlucaGen HypoKit at a
temperature not exceeding 25ºC for 18 months provided that the expiry
date is not exceeded. Store in the original package in
order to protect from light.
Do not freeze.
Health Products Regulatory Authority
01 December 2019
CRN0099FT
Page 2 of 2
If in rare cases, the reconstituted product shows any signs of fibril
formation (viscous appearance) or insoluble matter it should
be discarded.
6.5 NATURE AND CONTENTS OF CONTAINE