BRIDION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SUGAMMADEX

Available from:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC code:

V03AB35

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SUGAMMADEX 100 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

N.V. ORGANON, THE NETHERLANDS

Therapeutic group:

SUGAMMADEX

Therapeutic area:

SUGAMMADEX

Therapeutic indications:

Reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Authorization date:

2014-12-31

Summary of Product characteristics

Bridion
®
100 mg/mL
S
olution for injection
, IV
Sugammadex
1.
NAME OF THE M
EDICINAL PRODUCT
BRIDION
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL
contains sugammadex sodium
equivalent to 1
00 mg
sugammadex.
Each vial of 2 mL
contains sugammadex sodiu
m equivalent to 200
mg sugammadex.
Excipient(s)
with known effect
Contains up to 9.7 mg/mL
sodium (see section
4.4).
For the full list of excipients, se
e section 6.1.
3. PHARMACEUTICAL FORM
Solut
ion for injection
(injection).
Clea
r and colourless to sl
ightly 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 neu
romuscular blo
ckade induced b
y ro
curonium or vecuro
nium.
4.2 POSOLO
GY AND METHOD OF ADMIN
ISTRATION
Posology
Sugammadex should only be administered by, or under the supervision of
an anaesthetist.
The use of an appropriate neuromuscular monito
ring techniq
ue is recommen
ded to monitor
the
recovery of neurom
uscular blockade (see section 4.4).
Th
e recommended dose of sugammadex depends on the level of neuromuscular
blockade to
be reversed.
The recommended dose does not depend on the anaesthetic re
gimen.
Sugam
madex can be u
sed to reverse
dif
ferent levels of ro
curonium or vecur
onium induced
neuromus
cular blockade:
_Adults_
Routine reversal:
A dose of 4
mg/kg sugammadex is recommended if recovery has reached at least 1
-2 post-
tetanic counts (PTC) foll
owing rocuro
nium or vecuro
nium induced bl
ock
ade. Median time to
recovery of the T
4
/T
1
ratio to 0.9 is around 3
minutes (see section
5.1).
A dose of 2
mg/kg sugammadex is recommended, if spontaneous recovery has occurred
up to
at least the reappearance of T
2
following
rocuronium or
vecuronium indu
c
ed blockade.
Median time to recovery of the T
4
/T
1
ratio to 0
.9 is around 2
minutes (see section
5.1).
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 roc
uronium when co
mpared to vecuronium