BYDUREON BCISE INJECTION

Country: Afrika Selatan

Bahasa: Inggeris

Sumber: South African Health Products Regulatory Authority (SAHPRA)

Boleh didapati daripada:

AstraZeneca Pharmaceuticals (Pty) Ltd

Dos:

2,0 mg

Borang farmaseutikal:

INJECTION

Komposisi:

EACH DOSE (0,85 ml) CONTAINS EXENATIDE 2,0 mg

Status kebenaran:

Registered

Risalah maklumat

AstraZeneca
AstraZeneca Pharmaceuticals (Pty) Ltd
Version: 18 April 2023
Bydureon BCise
Prolonged release suspension for injection in pre-filled pen
Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
BYDUREON BCISE
2 mg prolonged release suspension for injection in pre-filled pen
EXENATIDE
CONTAINS SUGAR (SUCROSE): 0,8 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING BYDUREON
BCISE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
diabetic or other
health care provider.
•
Bydureon BCise has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
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 Bydureon BCise is and what it is used for
2.
What you need to know before you use Bydureon BCise
3.
How to use Bydureon BCise
4.
Possible side effects
5.
How to store Bydureon BCise
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AstraZeneca
AstraZeneca Pharmaceuticals (Pty) Ltd
Version: 18 April 2023
Bydureon BCise
Prolonged release suspension for injection in pre-filled pen
Page 2 of 12
6.
Contents of the pack and other information
1.
WHAT BYDUREON BCISE IS AND WHAT IT IS USED FOR
Bydureon BCise contains the active substance exenatide. It is an
injectable medicine used
to improve blood sugar control in adults with type 2 diabetes
mellitus.
This medicine is used in combination with the following diabetes
medicines: metformin,
sulphonylureas, thiazolidinediones, 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 h

Ciri produk

AstraZeneca
AstraZeneca Pharmaceuticals (Pty) Ltd
Version: 18 April 2023
Bydureon BCise
Prolonged release suspension for injection in pre-filled pen
Page 1 of 23
PROFESSIONAL INFORMATION
SCHEDULING STATUS
1
NAME OF THE MEDICINE
BYDUREON BCISE: 2 mg prolonged release suspension for injection in
pre-filled pen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled pen delivers a dose of 2 mg of exenatide in 0.85 mL.
Contains sugar (sucrose): 0,8 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release suspension for injection in a pre-filled pen.
White to off-white opaque suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bydureon BCise 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.
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
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AstraZeneca
AstraZeneca Pharmaceuticals (Pty) Ltd
Version: 18 April 2023
Bydureon BCise
Prolonged release suspension for injection in pre-filled pen
Page 2 of 23
Posology
The recommended dose is 2 mg exenatide once weekly.
Patients switching from immediate-release exenatide (Byetta) to
prolonged-release
exenatide (Bydureon BCise) may experience transient elevations in
blood glucose
concentrations, which generally improve within the first four weeks
after initiation of
therapy.
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).
Prolonged-release exenatide should be adminis