Bydureon

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

exenatide

Διαθέσιμο από:

AstraZeneca AB

Φαρμακολογική κατηγορία (ATC):

A10BJ01

INN (Διεθνής Όνομα):

exenatide

Θεραπευτική ομάδα:

Drugs used in diabetes

Θεραπευτική περιοχή:

Diabetes Mellitus, Type 2

Θεραπευτικές ενδείξεις:

Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations).Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with:MetforminSulphonylureaThiazolidinedioneMetformin and sulphonylureaMetformin and thiazolidinedionein adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Περίληψη προϊόντος:

Revision: 25

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-06-17

Φύλλο οδηγιών χρήσης

104
B. PACKAGE LEAFLET
105
PACKAGE LEAFLET: INFORMATION FOR THE USER
BYDUREON 2 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR
INJECTION
exenatide
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
diabetes 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
diabetes nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bydureon is and what it is used for
2.
What you need to know before you use Bydureon
3.
How to use Bydureon
4.
Possible side effects
5.
How to store Bydureon
6.
Contents of the pack and other information
1.
WHAT BYDUREON IS AND WHAT IT IS USED FOR
Bydureon contains the active substance exenatide. It is an injectable
medicine used to improve blood
sugar control in adults, adolescents and children aged 10 years and
above with type 2 diabetes
mellitus.
This medicine is used in combination with the following diabetes
medicines: metformin,
sulphonylureas, thiazolidinediones (combination therapy with
thiazolidinedione was only studied in
adult patients), SGLT2 inhibitors and/or a long-acting insulin. Your
doctor is now prescribing this
medicine as an additional medicine to help control your blood sugar.
Continue to follow your food and
exercise plan.
You have diabetes because your body does not make enough insulin to
control the level of sugar in
your blood or your body is not able to use the insulin properly. This
medicine helps your body to
increase the production of insulin when your blood sugar is high.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BYDUREON
DO NOT USE BYDUREON:
-
If you are allergic to exenatide or any of the other ingredients of
this medicine (listed

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bydureon 2 mg powder and solvent for prolonged-release suspension for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2 mg of exenatide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
Powder: white to off-white powder.
Solvent: clear, colourless to pale yellow to pale brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bydureon is indicated in adults, adolescents and children aged 10
years and above with type 2 diabetes
mellitus to improve glycaemic control in combination with other
glucose-lowering medicinal products
including basal insulin, when the therapy in use, together with diet
and exercise, does not provide
adequate glycaemic control.
For study results with respect to combinations, effects on glycaemic
control and cardiovascular events,
and the populations studied, see sections 4.4, 4.5, and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2 mg exenatide once weekly.
Patients switching from immediate-release (Byetta) to
prolonged-release (Bydureon or Bydureon
BCise) exenatide, may experience transient elevations in blood glucose
concentrations, which
generally improve within the first two weeks after initiation of
therapy. Patients switching between the
prolonged-release exenatide products (Bydureon or Bydureon BCise) may
do so, with no expected
relevant effect on blood glucose concentrations.
When prolonged-release exenatide is added to existing metformin and/or
thiazolidinedione therapy,
the current dose of metformin and/or thiazolidinedione can be
continued. When added to
sulphonylurea therapy, a reduction in the dose of sulphonylurea should
be considered to reduce the
risk of hypoglycaemia (see section 4.4). Combination therapy with
thiazolidinedione was only studied
in adult patients.
Prolonged-release exenatide should be administered once a week on the
same