Amglidia

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

glibenclamide

Saatavilla:

Ammtek

ATC-koodi:

A10BB01

INN (Kansainvälinen yleisnimi):

glibenclamide

Terapeuttinen ryhmä:

Drugs used in diabetes

Terapeuttinen alue:

Diabetes Mellitus

Käyttöaiheet:

Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children.Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the β-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus.

Tuoteyhteenveto:

Revision: 7

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-05-24

Pakkausseloste

B.
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMGLIDIA 0.6 MG/ML ORAL SUSPENSION
glibenclamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
•
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as those of your
child.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What A
mglidia is and what it is used for
2.
What you need to know before you give Amglidia
3.
How to give Amglidia
4.
Possible side effects
5.
How to store Amglidia
6.
Contents of the pack and other information
1.
WHAT AMGLIDIA IS AND WHAT IT IS USED FOR
Amglidia contains the active substance called glibenclamide which
belongs to a group of medicines
called sulphonylureas used for lowering blood sugar (blood-glucose).
Amglidia is used in newborns, infants and children to treat diabetes
that occurs at birth (known as
neonatal diabetes mellitus). Neonatal diabetes is a disease where the
child’s body does not release
enough insulin to control the level of blood sugar; Amglidia is used
only in patients who still have
some ability to make insulin.
Sulphonylureas like glibenclamide have been shown to be effective in
certain genetic mutations
responsible for the genesis of neonatal diabetes.
This medicine is an oral suspension, to be taken by mouth, which is a
more convenient treatment for
newborns and children compared to regular injections of insulin.
You must talk to a doctor if your child does not feel better or if
he/she feels worse after a few days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE AMGLIDIA
DO NOT GIVE AMGLIDIA
-
if your child is allergic to glibenclamide or any of the other
ingredients of this medicine
(li

Valmisteyhteenveto

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AMGLIDIA 0.6 mg/mL oral suspension AMGLIDIA 6 mg/mL oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMGLIDIA 0.6
mg/mL oral suspension
Each mL contains 0.6 mg glibenclamide.
AMGLIDIA 6 mg/mL oral suspension
Each mL contains 6 mg glibenclamide.
Excipient(s) with known effect
Each mL contains 2.8 mg of sodium and 5 mg of benzoate (E211). For the
full list of excipients, see
section 6.1
3.
PHARMACEUTICAL FORM
Oral suspension.
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AMGLIDIA is indicated for the treatment of neonatal diabetes mellitus,
for use in newborns, infants
and children.
Sulphonylureas like AMGLIDIA have been shown to be effective in
patients with mutations in the
genes coding for the β-cell ATP-sensitive potassium channel and
chromosome 6q24-related transient
neonatal diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Glibenclamide suspension therapy should be initiated by a physician
experienced in the treatment of
patients with very early onset diabetes.
Prescription instructions
_ _
Care should be taken when prescribing and administering AMGLIDIA to
avoid dosing errors due to
confusion between milligram (mg) and millilitre (mL). It should be
ensured that the proper dose and
strength are communicated and dispensed.
Posology
To avoid exceeding sodium benzoate acceptable daily dose, AMGLIDIA
daily dose should not exceed
1 mL/kg/day. As a consequence, AMGLIDIA 0.6 mg/mL should not be used
for posology higher than
0.6 mg/kg/day.
To limit exposure to sodium benzoate and with respect to the mode of
delivery (1 mL and 5 mL oral
syringes), it is not recommended to use the AMGLIDIA 0.6 mg/mL
strength for posologies higher
than the ones described below:
Table 1 : Maximum recommended posology
BODY WEIGHT (KG)
MAXIMUM RECOMMENDED POSOLOGY (EXPRESSED AS
MG/KG/DAY) WHERE THE AMGLIDIA 0.6 MG/ML
STRENGTH CAN BE USED
Up to 10
0.6
11
0.5
12
0.5
13
0.4
14
0.4
15
0.4
16
0.3
17
0.3
18
0.3
19
0.3
20
0.