Bridion solution for i/v injection

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

sugammadex (sugammadex sodium)

Disponível em:

N.V. Organon

Código ATC:

V03AB35

DCI (Denominação Comum Internacional):

sugammadex (sugammadex sodium)

Dosagem:

100mg/ml

Forma farmacêutica:

solution for i/v injection

Unidades em pacote:

(10) glass vials 2ml

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2023-01-10

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS FOR MEDICAL USE OF DRUG
1. NAME OF THE MEDICINAL PRODUCT
Bridion 100 mg/mL solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1. Qualitative composition
Sugammadex.
2.2 Quantitative composition
Each vial of 2 mL contains
_active substance_
: sugammadex sodium equivalent to 200 mg sugammadex.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless to slightly yellow solution.
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 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 anesthetist. The use
of an appropriate neuromuscular monitoring technique is 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 of the T
4
/T
1
ratio to 0.9 of rocuronium when compared to ve