SUGAMMADEX-TEVA SOLUTION FOR INJECTION 100MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Sugammadex Sodium eqv. to Sugammadex

Available from:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC code:

V03AB35

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Sugammadex Sodium eqv. to Sugammadex 100mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

PLIVA Croatia Ltd.

Authorization status:

ACTIVE

Authorization date:

2024-02-26

Summary of Product characteristics

Dieline
Black
Adobe InDesign 2021
CP: No
660x330mm
N/A
3.0
SW
11-12-23
Neo Sans For Teva: 9pt
23333_s3
13-7-22
Submission
SMPC
Rachel
P:Sugammadex, Singapore,
Injection 100mg/ml, 2ml/vial,
Teva (Zagreb)
SINGAPORE (SG)
PLIVA CROATIA Ltd.
National
SW
SUGAMMADEX-TEVA
SOLUTION FOR INJECTION 100 MG/ML
1.
NAME OF THE MEDICINAL PRODUCT
Sugammadex-Teva solution for injection 100 mg/ml
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.
For a full list of excipients, see section 6.1.
Excipient(s):
Each ml solution contains approximately 9.7mg sodium (see section
4.4).
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless to slightly yellow solution.
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
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_
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 recove