Baqsimi

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

Glucagon

זמין מ:

Eli Lilly Nederland B.V.

קוד ATC:

H04AA01

INN (שם בינלאומי):

glucagon

קבוצה תרפויטית:

Pancreatic hormones, Glycogenolytic hormones

איזור תרפויטי:

Diabetes Mellitus

סממני תרפויטית:

Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 4 years and over with diabetes mellitus.

leaflet_short:

Revision: 1

מצב אישור:

Authorised

תאריך אישור:

2019-12-16

עלון מידע

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BAQSIMI 3 MG NASAL POWDER IN SINGLE-DOSE CONTAINER
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Baqsimi is and what it is used for
2.
What you need to know before you are given Baqsimi
3.
How Baqsimi is given
4.
Possible side effects
5.
How to store Baqsimi
6.
Contents of the pack and other information
1.
WHAT BAQSIMI IS AND WHAT IT IS USED FOR
Baqsimi 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
4 years or older.
Glucagon is a natural hormone produced by the pancreas. It works in
the opposite way to insulin and
raises blood sugar. It does this by converting stored sugar in the
liver called glycogen to glucose (a
form of sugar that the body uses for energy). The glucose then enters
the bloodstream and raises the
blood sugar level, so reducing the effects of hypoglycaemia.
You should always carry Baqsimi with you and tell your friends and
family that you are carrying it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BAQSIMI
_ _
IMPORTANT INFORMATION
If you are at risk of severe hypoglycaemia you should always have
Baqsimi readily available:
-
show your family members, friends, or people you work with where you
keep this medicine and
explain when and how to use it. Delay in treatment may be harmful

מאפייני מוצר

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Baqsimi 3 mg nasal powder in single-dose container
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose container delivers nasal powder with 3 mg of
glucagon.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal powder in single-dose container (nasal powder).
White to practically white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baqsimi is indicated for the treatment of severe hypoglycaemia in
adults, adolescents, and children
aged 4 years and over with diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, adolescents and children aged 4 years and over _
The recommended dose is 3 mg glucagon administered into one nostril.
_Elderly _
(≥ 65 years)
_ _
No dose adjustment is required based on age.
Efficacy and safety data are very limited in patients aged 65 years
and absent in patients aged 75 and
above.
_ _
_Renal and hepatic impairment _
No dose adjustment is required based on renal and hepatic function.
_ _
_Paediatric population 0 - < 4 years _
The safety and efficacy of Baqsimi in infants and children aged 0 to <
4 years have not yet been
established. No data are available.
Method of administration
Nasal use only. Glucagon nasal powder is given in a single nostril.
Glucagon is passively absorbed
through the nasal mucosa. It is not necessary to inhale or breathe
deeply after dosing.
INSTRUCTIONS FOR ADMINISTERING GLUCAGON NASAL POWDER
1.
Remove the shrink wrap by pulling on the red stripe.
2.
Remove the single-dose container from the tube. Do not press the
plunger until ready to give the
dose.
3.
Hold the single-dose container between fingers and thumb. Do not test
before use as it contains
3
only one dose of glucagon and cannot be reused.
4.
Insert the tip of the single-dose container gently in one of the
nostrils until finger(s) touch the
outside of the nose.
5.
Push the plunger all the way in. The dose is complete when the green
line is no longer show