SUGAMMADEX SCIGEN SOLUTION FOR INJECTION 100MGML

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Sugammadex Sodium eqv Sugammadex

Disponível em:

SCIGEN PTE. LTD.

Código ATC:

V03AB35

Forma farmacêutica:

INJECTION, SOLUTION

Composição:

Sugammadex Sodium eqv Sugammadex 100mg/ml

Via de administração:

INTRAVENOUS

Tipo de prescrição:

Prescription Only

Fabricado por:

MEFAR İLAÇ SANAYII A.Ş.

Status de autorização:

ACTIVE

Data de autorização:

2024-01-23

Características técnicas

SUGAMMADEX SCIGEN SOLUTION FOR INJECTION 100 MG/ML
1. NAME OF THE MEDICINAL PRODUCT
SUGAMMADEX SCIGEN solution for injection 100mg/ml
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.
For a full list of excipients, see section 6.1.
Excipient(s):
Each ml contains up to 9.5 mg sodium (see section 4.4).
3. PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless to slightly yellow/brown solution free from
visible particles.
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
Posology
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 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 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 compa