Bridion

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sugammadex 100 mg/mL (as sodium);  ;  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Sugammadex 100 mg/mL

Dosage:

100 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Sugammadex 100 mg/mL (as sodium)     Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Units in package:

Vial, glass, 5mL vials, 10 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

Therapeutic indications:

Bridion is indicated for the reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older

Product summary:

Package - Contents - Shelf Life: Vial, glass, 5mL vials - 10 dose units - 36 months from date of manufacture stored at or below 30°C - Vial, glass, 2mL vials - 10 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2007-12-05

Patient Information leaflet

BRIDION
®
100 mg/mL
1
BRIDION
®
_100 MG/ML _
_Sugammadex _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BRIDION.
It does not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
BRIDION against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, TELL YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BRIDION IS USED
FOR
BRIDION belongs to a group of
medicines called Selective Relaxant
Binding Agents. It is used to speed
up recovery of your muscles after an
operation.
During some operations, your
muscles must be completely relaxed.
This makes it easier for the surgeon
to perform the operation. To make
your muscles relax, the general
anaesthetic includes muscle relaxants
such as rocuronium or vecuronium.
Because the muscles needed for
breathing also become relaxed, you
will need help with your breathing
(artificial ventilation) during and
after your operation until you can
breathe on your own again.
BRIDION is used to stop the muscle
relaxants working. It does this by
combining with rocuronium or
vecuronium in your body.
BRIDION is given to speed up your
recovery from the muscle relaxant -
for example, at the end of an
operation to allow you to breathe
normally earlier.
Your doctor will have explained why
you are being treated with BRIDION.
ASK YOUR DOCTOR IF YOU WANT ANY
MORE INFORMATION ABOUT THIS
MEDICINE.
BRIDION is not addictive.
BEFORE YOU ARE GIVEN
BRIDION
You may already have been given
BRIDION Injection. Your doctor
will have considered the situation
carefully and decided to use it.
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN BRIDION
IF:
•
you are allergic to sugammadex
or have an allergy to any of the
ingredients listed at the end of
this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of

Summary of Product characteristics

Page 1 of 21
NEW ZEALAND DATA SHEET
1 PRODUCT NAME
BRIDION 100 mg/mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sugammadex 100 mg/mL
2 mL contains sugammadex sodium equivalent to 200 mg sugammadex.
5 mL contains 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
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.
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
Page 2 of 21
time
to
recovery of the
T
4
/T
1
ratio
to
0.9
is
around
2
minutes
(see SECTION 5.1
PHARMACODYNAMIC PROPERTIES, CLINICAL EFFICACY AND SAFETY).
Using the recommended doses for routine reversal will result in a
slightly faster median time
to recovery of the T
4
/T
1
ratio to 0.9 of rocuronium-induced blockade, when compared