BRIDION

Šalis: Indonezija

kalba: indoneziečių

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

Veiklioji medžiaga:

SUGAMMADEX

Prieinama:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Tarptautinis Pavadinimas):

SUGAMMADEX

Dozė:

100 MG

Vaisto forma:

INJEKSI

Vienetai pakuotėje:

DUS, 10 VIAL @ 2 ML

Pagaminta:

N.V. ORGANON - Netherlands

Leidimo data:

2020-03-17

Prekės savybės

BRIDION

Sugammadex
Solution for injection
1.
NAME OF THE MEDICINAL PRODUCT
Bridion 100 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains sugammadex sodium equivalent to 100 mg sugammadex.
2 ml contains sugammadex sodium equivalent to 200 mg sugammadex.
5 ml contains sugammadex sodium equivalent to 500 mg sugammadex.
For a full list of excipients, see section 6.1.
Excipient(s):
Each ml contains up to 9.7 mg sodium (see section 4.4).
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless to slightly yellow solution.
The pH is between 7 and 8 and osmolality is between 300 and 500
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Reversal
of neuromuscular blockade induced by rocuronium or vecuronium
in
patients 2 years of age and older.
4.2
Posology and method of administration
Sugammadex should only be administered by, or under the supervision of
an
anesthetist. The use of an appropriate neuromuscular monitoring
technique is
DISETUJUI OLEH BPOM: 19/01/2023
ID: EREG10037312100021
recommended to monitor the recovery of neuromuscular blockade (see
section
4.4).
The
recommended
dose
of
sugammadex
depends
on
the
level
of
neuromuscular blockade to be reversed.
The recommended dose does not depend on the anesthetic regimen.
Sugammadex
can be used to reverse different
levels
of
rocuronium or
vecuronium induced neuromuscular blockade:
Adults
Routine reversal:
A dose of
4 mg/kg sugammadex is recommended if
recovery has reached at
least
1-2 post-tetanic
counts
(PTC)
following rocuronium or
vecuronium
induced blockade. Median time to recovery of the T
4
/T
1
ratio to 0.9 is around 3
minutes (see section 5.1).
A dose of
2 mg/kg sugammadex is recommended,
if
spontaneous recovery
has occurred up to at
least
the reappearance of
T
2
following rocuronium or
vecuronium induced blockade. Median time to recovery of the T
4
/T
1
ratio to 0.9
is around 2 minutes (see section 5.1).
Using the recommended doses for routine reversal will result in a
slightly faster
m