BRIDION 100MG/ML SOLUTION FOR INJECTION

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

SUGAMMADEX

Предлага се от:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Международно Name):

SUGAMMADEX

Броя в опаковка:

10x2ml Vials

Произведено от:

N.V. ORGANON

Данни за продукта

CCDS-MK8616-SOi-082019
BRIDION
Solution for injection, 100 mg/ml
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
Each vial of 2 ml contains sugammadex sodium equivalent to 200 mg
sugammadex
Each vial of 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 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.
For the pediatric population: sugammadex is only recommended for
routine reversal
of rocuronium induced blockade in children and adolescents.
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
recommended to monitor the recovery of neuromuscular blockade.
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 T4/T1 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 T2 following rocuronium or
vecuronium
induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is
around 2
minutes (see section 5.1).
Using the recommende