SUGAMMADEX-TEVA sugammadex (as sodium) 200 mg/2 mL solution for injection vial

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

sugammadex sodium, Quantity: 217.6 mg (Equivalent: sugammadex, Qty 200 mg)

Disponible depuis:

Teva Pharma Australia Pty Ltd

forme pharmaceutique:

Injection, solution

Composition:

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

Mode d'administration:

Intravenous

Unités en paquet:

10 vials

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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

Descriptif du produit:

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

Statut de autorisation:

Registered

Date de l'autorisation:

2023-03-28

Notice patient

SUGAMMADEX-TEVA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SUGAMMADEX-TEVA?
SUGAMMADEX-TEVA contains the active ingredient sugammadex (as sodium).
SUGAMMADEX-TEVA is used to speed up
recovery of your muscles after an operation.
For more information, see Section 1. Why am I using SUGAMMADEX-TEVA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SUGAMMADEX-TEVA?
Do not use if you have ever had an allergic reaction to sugammadex or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
SUGAMMADEX-TEVA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SUGAMMADEX-TEVA and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SUGAMMADEX-TEVA?
SUGAMMADEX-TEVA is given as a single injection through an intravenous
line. The doctor will work out the dose of
SUGAMMADEX-TEVA you need based on your weight and how much muscle
relaxant is still affecting you.
More instructions can be found in Section 4. How do I use
SUGAMMADEX-TEVA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SUGAMMADEX-TEVA?
DRIVING
OR USING
MACHINES
•
Your doctor will tell you when it is safe to drive and operate
potentially dangerous machinery. As far as it
is known, SUGAMMADEX-TEVA has no effect on alertness or concentration.
STORAGE
•
SUGAMMADEX-TEVA is stored in the hospital according to the storage
conditions on the pack.
For more information, see Section 5. What should I know while using
SUGAMMADEX-TEVA? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Like all medicines, SUGAMMADEX-TEVA can cause side effects, but not
ev

Résumé des caractéristiques du produit

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