BYETTA 10

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Exenatide 250 µg/mL;  

Fáanlegur frá:

AstraZeneca Limited

INN (Alþjóðlegt nafn):

Exenatide 250 µg/mL

Skammtar:

10µg/40µL

Lyfjaform:

Solution for injection

Samsetning:

Active: Exenatide 250 µg/mL   Excipient: Glacial acetic acid Mannitol Metacresol Sodium acetate trihydrate Water for injection

Einingar í pakka:

Cartridge, glass, 2.4 mL (2.7 mL cartridge), 1 dose unit

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Bachem Americas Inc

Ábendingar:

Adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea but are not achieving adequate glycaemic control. To improve glycaemic control in patients with type 2 diabetes mellitus in combination with a basal insulin with or without metformin and/or a thiozolidinedione.

Vörulýsing:

Package - Contents - Shelf Life: Cartridge, glass, 2.4 mL (2.7 mL cartridge) - 60 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days opened stored at or below 25°C protect from light

Leyfisdagur:

2005-11-28

Upplýsingar fylgiseðill

Byetta® CMI 270520
Copyright
1(7)
BYETTA
®
EXENATIDE 5 ΜG/20 ΜL OR 10 ΜG/40 ΜL SOLUTION FOR INJECTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
BYETTA. It does not contain all
the information that is known about BYETTA.
It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date shown on
the final page. More recent
information on this medicine may be available. Make sure you speak to
your pharmacist, nurse or
doctor to obtain the most up to date information on this medicine.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking BYETTA
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT IS BYETTA IS USED FOR
BYETTA is an injectable medicine used to improve blood sugar control
in adults with type 2 diabetes
mellitus.
BYETTA
is
used
with
other
diabetic
medicines
such
as
metformin,
sulphonylureas,
thiazolidinediones and basal or long acting insulins. Your doctor is
now prescribing BYETTA as an
additional medicine to help control your blood sugar.
Diabetes mellitus is a condition in which your pancreas does not
produce enough insulin to control
your blood sugar level. BYETTA helps your body to increase production
of insulin when your blood
sugar is high. BYETTA IS NOT A SUBSTITUTE FOR INSULIN IN PATIENTS WHO
REQUIRE INSULIN TREATMENTS
FOR THEIR DIABETES.
This medicine has not been studied in children.
This medicine is only available with a doctor's prescription.
Ask your doctor if you have any questions about why this medicine has
been prescribed for you.
BEFORE YOU USE BYETTA
_WHEN YOU MUST NOT USE IT _
Do not use BYETTA if:

you have type 1 diabetes or diabetic ketoacidosis (often caused by
very high blood
glucose levels).

you are allergic to exenatide or meta-Cr

Vara einkenni

B
YETTA
Data Sheet 160822
Copyright
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
B
YETTA
®
5 micrograms; Solution for Injection.
B
YETTA
®
10 micrograms; Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
B
YETTA
5: Each dose contains 5 micrograms (µg) of exenatide in 20
microlitres (µL),
(250 µg exenatide per mL.
B
YETTA
10: Each dose contains 10 micrograms (µg) of exenatide in 40
microlitres (µL),
(250 µg exenatide per mL).
Excipient with known effect:
B
YETTA
5: Each dose contains 44 µg metacresol.
B
YETTA
10: Each dose contains 88 µg metacresol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
B
YETTA
is a clear colourless solution.
B
YETTA
is supplied as a sterile, preserved solution for subcutaneous
injection in a glass
cartridge that has been assembled in an injector pen.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
B
YETTA
is indicated as adjunctive therapy to improve glycaemic control in
patients with
type 2 diabetes mellitus who are taking metformin, a sulphonylurea, or
a combination
of metformin and a sulphonylurea but are not achieving adequate
glycaemic control.
Exenatide is indicated to improve glycaemic control in patients with
type 2 diabetes
mellitus in combination with a basal insulin, with or without
metformin and/or a
thiazolidinedione.
4.2
DOSE AND METHOD OF ADMINISTRATION
B
YETTA
therapy should be initiated at 5 μg exenatide per dose administered
twice daily
(BID) for at least one month in order to improve tolerability. The
dose of B
YETTA
can
then be increased to 10 μg BID to further improve glycaemic control.
Doses higher
than 10 µg BID are not recommended.
B
YETTA
Data Sheet 160822
Copyright
2
B
YETTA
can be administered at any time within the 60-minute period before the
morning and evening meals (or before the two main meals of the day,
approximately
6 hours or more apart).
B
YETTA
SHOULD NOT be administered after a meal.
If an
injection is missed, the treatment should be continued with the next
scheduled dose.