BRIDION sugammadex 200 mg/2 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sugammadex sodium, Quantity: 217.6 mg

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Sugammadex

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

2 mL vials x 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: A clear and colourless to slightly yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store between 2-30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-11-28

Patient Information leaflet

BRIDION
®
B
R
I
D
I
O
N
®
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 BRIDION?
BRIDION contains the active ingredient sugammadex sodium. BRIDION is
used to speed up recovery of your muscles after an
operation.
For more information, see Section 1. Why am I using BRIDION? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BRIDION?
Do not use if you have ever had an allergic reaction to BRIDION 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
BRIDION? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BRIDION 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 BRIDION?
•
BRIDION is given as a single injection through an intravenous line.
The doctor will work out the dose of BRIDION 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 BRIDION? in
the full CMI.
5.
WHAT SHOULD I KNOW AFTER BEING GIVEN BRIDION?
DRIVING
OR USING
MACHINES
•
Your doctor will tell you when it is safe to drive and operate
potentially dangerous machinery.
For more information, see Section 5. What should I know after being
given BRIDION? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Like all medicines, BRIDION can cause side effects, but not everyone
gets them.
If these side effects occur while you are under anaesthetic, they will
be seen and treated by your anaesthetist.
For more information, including what to do if you have any side
effects, see Section 6. Are there any side effects? in the full CMI.
BRIDION®
1
BRIDION
®
ACTIVE INGREDIENT(S): _sugamma

Summary of Product characteristics

Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
BRIDION
®
(SUGAMMADEX)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Sugammadex (as sodium salt)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sugammadex is a white to off-white powder. It is soluble at room
temperature in water, normal
saline and 5% mannitol in water.
Bridion solution for injection contains sugammadex 100 mg/mL.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Bridion solution for injection is a 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
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 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:
Page 2 of 22
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 TRIALS).
A dose of 2.0 mg/kg sugammadex is recommended, i