SUGAMMADEX SANDOZ SOLUTION FOR INJECTION 100MG ML

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

Sugammadex sodium eqv Sugammadex

Dostupno od:

SANDOZ SINGAPORE PTE. LTD.

ATC koda:

V03AB35

Farmaceutski oblik:

INJECTION, SOLUTION

Sastav:

Sugammadex sodium eqv Sugammadex 100.0 mg/mL

Administracija rute:

INTRAVENOUS

Tip recepta:

Prescription Only

Proizveden od:

Lek Pharmaceuticals, d.d.

Status autorizacije:

ACTIVE

Datum autorizacije:

2023-10-11

Svojstava lijeka

Page 1 of 24
1.
NAME OF THE MEDICINAL PRODUCT
SUGAMMADEX SANDOZ 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.
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 a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless to slightly yellow-brown solution, practically
free from visible particles.
The pH is between 7.0 and 8.0 and osmolality is between 300 and 500
mOsmol/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_
_ _
_ _
Page 2 of 24
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
reco