BYETTA

מדינה: אינדונזיה

שפה: אינדונזית

מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

מרכיב פעיל:

EXENATIDE

זמין מ:

ASTRAZENECA INDONESIA - Indonesia

INN (שם בינלאומי):

EXENATIDE

כמות:

0,25 MG/ML

טופס פרצבטיות:

CAIRAN INJEKSI

יחידות באריזה:

DUS, 1 PRE FILLED PEN @ 60 DOSIS @ 10 MCG (2,4 ML)

תוצרת:

BAXTER PHARMACEUTICAL SOLUTION LLC-USA

תאריך אישור:

2018-10-23

מאפייני מוצר

1
BYETTA
TM
_exenatide _
SOLUTION FOR INJECTION
NAME OF THE MEDICINAL PRODUCT
BYETTA 5 micrograms solution for injection, prefilled pen
BYETTA 10 micrograms solution for injection, prefilled pen
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in BYETTA is exenatide.
BYETTA 5 microgram prefilled pen: Each dose contains 5 micrograms
(µg) synthetic exenatide in
20 microlitres (µl), (0.25 mg exenatide per ml).
BYETTA 10 microgram prefilled pen: Each dose contains 10 micrograms
(µg) synthetic exenatide in
40 microlitres (µl), (0.25 mg exenatide per ml).
Excipients:
BYETTA 5 microgram: Each dose contains 44 µg metacresol.
BYETTA 10 microgram: Each dose contains 88 µg metacresol.
This medicinal product contains less than 1mmol sodium per dose, i.e.
essentially “sodium-free”.
For a full list of excipients, see section _List of excipient_.
PHARMACEUTICAL FORM
Solution for injection, prefilled pen.
Clear, colourless solution.
THERAPEUTIC INDICATIONS
BYETTA is indicated as an adjunct to diet and exercise for treatment
of type 2 diabetes mellitus in
combination with:
-
metformin
-
sulphonylureas
-
metformin and a sulphonylureas
in patients who have not achieved adequate glycaemic control on
maximally tolerated doses of these
oral therapies.
BYETTA is also indicated as adjunctive therapy to basal insulin with
or without metformin in adults
who have not achieved adequate glycaemic control with these agents
POSOLOGY AND METHOD OF ADMINISTRATION
BYETTA 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
exenatide can then be increased to 10 µg
BID to further improve glycaemic control. Doses higher than 10 µg BID
are not recommended.
BYETTA is available as either a 5 µg or a 10 µg exenatide per dose
prefilled pen.
BYETTA can be administered at any time within the 60-minute period
before the morning and
evening meal (or two main meals of the day, approximately 6 hours or
more apart). BYETTA should
DI