Ogluo

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

Glucagon

Beschikbaar vanaf:

Tetris Pharma B.V

ATC-code:

H04AA01

INN (Algemene Internationale Benaming):

glucagon

Therapeutische categorie:

Pancreatic hormones, Glycogenolytic hormones

Therapeutisch gebied:

Diabetes Mellitus

therapeutische indicaties:

Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

Product samenvatting:

Revision: 5

Autorisatie-status:

Authorised

Autorisatie datum:

2021-02-11

Bijsluiter

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
OGLUO 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
OGLUO 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
glucagon
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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 Ogluo is and what it is used for
2.
What you need to know before you use Ogluo
3.
How to use Ogluo
4.
Possible side effects
5.
How to store Ogluo
6.
Contents of the pack and other information
1.
WHAT OGLUO IS AND WHAT IT IS USED FOR
Ogluo contains the active substance glucagon, which belongs to a group
of medicines called
glycogenolytic hormones.
It is used to treat severe hypoglycaemia (very low blood sugar) in
people with diabetes. It is for use in
adults, adolescents, and children aged 2 years or older.
Ogluo is a ready-to-use, pre-filled pen that contains a single dose of
the active substance, glucagon. It
is a subcutaneous injection, meaning that the medicine is administered
under the skin using a needle.
Glucagon is a natural hormone produced by the pancreas, which has the
opposite effect of insulin in
the human body. It helps the liver to convert stored sugar in the
liver called ‘glycogen’ into glucose
(sugar). Glucose is then released into the blood stream, which makes
the blood sugar level rise,
reducing the effects of hypoglycaemia.
INFORMATION ON HYPOGLYCAEMIA
Early symptoms of hypoglycaemia (low blood sugar) include:
•
sweating
•
drowsiness
•
dizziness
•
sleep disturbances
•
palpitation
•
anxiety
•
tremor
•
blurred vision
•
hunger
•

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ogluo 0.5 mg solution for injection in pre-filled pen.
Ogluo 1 mg solution for injection in pre-filled pen.
Ogluo 0.5 mg solution for injection in pre-filled syringe.
Ogluo 1 mg solution for injection in pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ogluo 0.5 mg solution for injection in pre-filled pen
Each pre-filled pen contains 0.5 mg glucagon in 0.1 mL.
Ogluo 1 mg solution for injection in pre-filled pen
Each pre-filled pen contains 1 mg glucagon in 0.2 mL.
Ogluo 0.5 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 0.5 mg glucagon in 0.1 mL.
Ogluo 1 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 1 mg glucagon in 0.2 mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
A clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ogluo is indicated for the treatment of severe hypoglycaemia in
adults, adolescents, and children aged
2 years and over with diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents (≥6_
_years)_
The recommended dose is 1 mg, administrated by subcutaneous injection.
_Paediatric population (≥2 to <6_
_years) _
3
•
The recommended dose for paediatric patients who weigh less than 25 kg
is 0.5 mg
administered by subcutaneous injection.
•
The recommended dose for paediatric patients who weigh 25 kg or
greater is 1 mg administered
by subcutaneous injection.
_ _
_Time to respond and additional doses _
The patient will normally respond within 15 minutes. When the patient
has responded to the treatment,
give an oral carbohydrate to restore the liver glycogen and prevent
relapse of hypoglycaemia. If the
patient does not respond within 15 minutes, an additional dose of
Ogluo from a new device may be
administered while waiting for emergency assistance. It is recommended
that patients are prescribed