Bridion solution for i/v injection

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

sugammadex (sugammadex sodium)

Disponibil de la:

N.V. Organon

Codul ATC:

V03AB35

INN (nume internaţional):

sugammadex (sugammadex sodium)

Dozare:

100mg/ml

Forma farmaceutică:

solution for i/v injection

Unități în pachet:

(10) glass vials 2ml

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2020-05-16

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
Excipient(s)
with known effect
Contains up to 9.7 mg/mL
sodium (see
section 4.4).
For the full lis
t of excipients, see section
6.1.
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 PARTICULAR
S
4.1
THERAP
EUTIC INDICATIONS
Reversal of neuromuscular blockade induced by rocuronium or vecuronium
in adults.
For the paediatric population: sugammadex is only recommended for
routine reversal of rocuronium
induced bl
ockade in chil
dren and adolescents
aged 2 to 17 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Sugammadex should only be administered by, or under the supervision of
an anaesthetist.
The use of an appropriate neuromuscular monitoring techniq
ue is recommen
ded to monitor the
recovery of ne
uromuscular 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 anaesthetic regimen.
Sugam
madex can be u
sed to reverse different
levels o
f 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 rocuro
nium or vecuro
nium induced blockade. M
edian tim
e 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 block
ade. Median time to
recovery of