BYDUREON 2 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EXENATIDE

Available from:

ASTRAZENECA (ISRAEL) LTD

ATC code:

A10BX04

Pharmaceutical form:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Composition:

EXENATIDE 2 MG

Administration route:

S.C

Prescription type:

Required

Manufactured by:

ASTRA ZENECA AB., SWEDEN

Therapeutic area:

EXENATIDE

Therapeutic indications:

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 including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control .

Authorization date:

2018-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
Name of the preparation:
BYDUREON
®
2 mg
Once a week injection pen
Powder
and
solvent
for
suspension
for
injection in pre-filled pen
Composition:
Each pen contains: Exenatide 2 mg
Inactive ingredients and allergens: see Section 6 “Further
Information”.
Read this leaflet carefully in its entirety before using this
medicine. This leaflet
contains
concise
information
about
the
medicine.
If
you
have
further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not
pass it on to others. It may harm them even if it seems to you that
their
ailment is similar.
This medicine is not intended for children below 18 years of age.
Essential information about Bydureon:
•
Bydureon used in combination with a sulphonylurea may cause a decrease
in blood sugar levels (hypoglycemia). Be sure to check your blood
sugar
level regularly during the course of treatment with the medicine (see
below
sections 2 “Before using the medicine” and 4 “Side effects”).
•
Bydureon is not intended for treatment of type 1 diabetes (insulin
dependent diabetes) and diabetic ketoacidosis.
•
Bydureon is intended for injection under the skin, once a week, at any
hour
of the day, and with no relation to meals.
•
Treatment with the medicine is not recommended for patients with
kidney
problems, patients on dialysis, women who are pregnant or
breastfeeding
(see section 2 below “Before using the medicine”).
1.
WHAT IS THE MEDICINE INTENDED FOR?
Bydureon is an injectable medicine used to improve control of blood
sugar
levels in adult patients with type 2 diabetes (diabetes mellitus).
Bydureon is
given in combination with additional anti-diabetes medicines:
metformin,
sulphonylurea, thiazolidinediones, SGLT2 inhibitors and/or a
long-acting
insulin.
Your doctor prescribed treatment with Bydureon for you as an
additional
medicin

Summary of Product characteristics

BYDUREON 2MG
1.
NAME OF THE MEDICINAL PRODUCT
BYDUREON 2 mg powder and solvent for prolonged-release suspension for
injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled pen contains 2 mg of exenatide. After reconstitution
suspension, each pen delivers a dose
of 2 mg in 0.65 ml.
For a 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 18 years and older 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 (see section
4.4, 4.5 and 5.1 for available data on different combinations).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2 mg exenatide once weekly.
Patients switching from exenatide twice daily (BYETTA) to BYDUREON may
experience transient
elevations in blood glucose concentrations, which generally improve
within the first two weeks after
initiation of therapy.
When BYDUREON is added to existing metformin and/or thiazolidinedione
therapy, the current dose of
metformin and/or thiazolidinedione can be continued. When BYDUREON is
added to sulphonylurea
therapy, a reduction in the dose of sulphonylurea should be considered
to reduce the risk of
hypoglycaemia (see section 4.4).
BYDUREON should be administered once a week on the same day each week.
The day of weekly
administration can be changed if necessary, as long as the next dose
is administered at least one day
(24 hours) later. BYDUREON can be administered at any time of day,
with or without meals.
If a dose is missed, it should be administered as soon as practical.
For the next injection patients can
return to their chosen injection day. Howeve