BRIDION

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

SUGAMMADEX

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

SUGAMMADEX

Dosis:

100 MG

Bentuk farmasi:

INJEKSI

Unit dalam paket:

DUS, 10 VIAL @ 2 ML

Diproduksi oleh:

PATHEON MANUFACTURING SERVICES, LLC - United States of America

Tanggal Otorisasi:

2021-06-17

Karakteristik produk

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.
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: 15/03/2021
ID: EREG10037312000064
Page 2 of 27
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
median time to recovery o