Sugammadex Juno

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Sugammadex sodium 108.8 mg/mL equivalent to sugammadex 100 mg/mL

Tillgänglig från:

Juno Pharmaceuticals NZ Limited

Dos:

200 mg/2mL

Läkemedelsform:

Solution for injection

Sammansättning:

Active: Sugammadex sodium 108.8 mg/mL equivalent to sugammadex 100 mg/mL Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Receptbelagda typ:

Prescription

Terapeutiska indikationer:

For the reversal of neuromuscular blockade induced by rocuronium or vecuronium

Produktsammanfattning:

Package - Contents - Shelf Life: Vial, glass, Type 1 with rubber stopper and aluminium flip-off seal with plastic cap 10 x 2 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Tillstånd datum:

2020-07-30

Produktens egenskaper

Sugammadex Juno Datasheet Version 2.0 Page 1 of 21
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Sugammadex Juno 200 mg/2 mL solution for injection
Sugammadex Juno 500 mg/5 mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sugammadex 100 mg/mL
2 mL contains 217.6 mg sugammadex sodium equivalent to 200 mg
sugammadex.
5 mL contains 543.9 mg sugammadex sodium equivalent to 500 mg
sugammadex.
Excipient(s) with known effect:
Each mL contains 9.7 mg sodium (See Section 4.4). For the full list of
excipients, see SECTION
6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless to slightly yellow solution in 2 mL or 5 mL
vials.
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
DOSE AND METHOD OF ADMINISTRATION
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.
ADULTS
Sugammadex can be used to reverse different levels of rocuronium or
vecuronium-induced
neuromuscular blockade:
Routine reversal
A dose of 4.0 mg/kg sugammadex is recommended if recovery has reached
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 PHARMACODYNAMIC
PROPERTIES,
CLINICAL EFFICACY AND SAFETY).
A dose of 2.0 mg/kg sugammadex is recommended, if spontaneous recovery
has occurred up
to the reappearance of T2 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
Sugammadex Juno Datasheet Version 2.0 Page 2 of 21
PHARMACODYNAMIC PROPERTIES, CLINICAL EFFICACY AND SAFETY).
Using the recommended doses for routine reversal will result i