SUGAMMADEX-TEVA sugammadex (as sodium) 500 mg/5 mL solution for injection vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

sugammadex sodium, Quantity: 544 mg (Equivalent: sugammadex, Qty 500 mg)

Tillgänglig från:

Teva Pharma Australia Pty Ltd

Läkemedelsform:

Injection, solution

Sammansättning:

Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide

Administreringssätt:

Intravenous

Enheter i paketet:

10 vials

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.

Produktsammanfattning:

Visual Identification: A clear, colourless to slightly yellow-brown solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2023-03-28

Produktens egenskaper

Sugammadex-Teva V1.0
1
AUSTRALIAN PRODUCT INFORMATION SUGAMMADEX-TEVA
(SUGAMMADEX) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Sugammadex (as sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SUGAMMADEX-TEVA 200 mg/2 mL solution for injection contains 200 mg
sugammadex (as sodium) in 2 mL
solution.
SUGAMMADEX-TEVA 500 mg/5 mL solution for injection contains 500 mg
sugammadex (as sodium) in 5 mL
solution.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SUGAMMADEX-TEVA 200 mg/2 mL and 500 mg/5 mL are a clear, colourless to
slightly yellow-brown
solution for injection. The pH is between 7 and 8 and osmolality is
between 300 and 500 mOsm/kg.
4
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Reversal of neuromuscular blockade induced by rocuronium or vecuronium
in patients 2 years of age and
older.
DOSE AND METHOD OF ADMINISTRATION
The use of an appropriate neuromuscular monitoring technique is
recommended to monitor the recovery
of neuromuscular blockade.
Adequacy of the reversal of the neuromuscular block needs to be based
on a clinical assessment of the
patient and
not
train-of-four
responses alone,
unless
quantitative
(numeric) assessment is made of
neuromuscular function.
Patients should be monitored for clinical signs of residual blockade
(e.g. difficulty maintaining a patent
airway, generalised weakness, inadequate ventilatory effort) following
cessation of the anaesthetic and
extubation.
The recommended dose of sugammadex depends on the level of
neuromuscular blockadeto 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)
Sugammadex-Teva V1.0
2
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 PROPERT