SUGAMMADEX SANDOZ SOLUTION FOR INJECTION 100MG ML

Pajjiż: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

Sugammadex sodium eqv Sugammadex

Disponibbli minn:

SANDOZ SINGAPORE PTE. LTD.

Kodiċi ATC:

V03AB35

Għamla farmaċewtika:

INJECTION, SOLUTION

Kompożizzjoni:

Sugammadex sodium eqv Sugammadex 100.0 mg/mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

Lek Pharmaceuticals, d.d.

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2023-10-11

Karatteristiċi tal-prodott

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