Bridion Solution For Injection 100mgml

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Sugammadex sodium 108.8mg eqv Sugammadex

Disponible des:

MSD PHARMA (SINGAPORE) PTE. LTD.

Codi ATC:

V03AB35

Dosis:

100mg

formulario farmacéutico:

INJECTION, SOLUTION

Composición:

Sugammadex sodium 108.8mg eqv Sugammadex 100mg

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricat per:

N.V. Organon

Estat d'Autorització:

ACTIVE

Data d'autorització:

2010-05-31

Informació per a l'usuari

OS SmPC-MK8616-SOi-102013 

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 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 paediatric 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 anaesthetist. 
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 anaesthetic 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 recommende

Fitxa tècnica

CCDS-MK8616-SOi-092020
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.
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 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
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 around 2 minutes (see section 5.1).
Using the recommended doses for routine reversal will result in a
slightly faster median time
to recovery of the T
4
/T
1
ratio to 0.9 of r