BRIDION 100MGML SOLUTION FOR INJECTION

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

SUGAMMADEX

Verfügbar ab:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Internationale Bezeichnung):

SUGAMMADEX

Einheiten im Paket:

10x2ml Vials

Hergestellt von:

N.V. ORGANON

Gebrauchsinformation

Not Applicable

Fachinformation

LOCAL PRODUCT CIRCULAR
LPC-MK8616-SOi-042020a-Malaysia
Solution for injection
BRIDION® 100 mg/ml
(sugammadex)
Bridion 100 mg/ml solution for injection
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).
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.
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.
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
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 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 arou