SUGAMAX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SUGAMMADEX AS SODIUM

Available from:

UNIPHARM TRADING LTD, ISRAEL

ATC code:

V03AB35

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SUGAMMADEX AS SODIUM 100 MG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PHARMIDEA,LATVIA

Therapeutic area:

SUGAMMADEX

Therapeutic indications:

Sugamax is indicated for reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Authorization date:

2023-02-12

Summary of Product characteristics

SUGAMAX
Solution for injection
Sugammadex (as sodium) 100 mg/mL
1.
NAME OF THE MEDICINAL PRODUCT
SUGAMAX,
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.
Excipient(s) with known effect
Contains up to 9.7 mg/mL sodium (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless to slightly yellow/brown solution free of
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.
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 (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.
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 compare