Bridion
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
25-09-2023
Charakterystyka produktu
(SPC)
25-09-2023
Sprawozdanie z oceny publicznego
(PAR)
17-12-2015
Składnik aktywny:
sugammadex
Dostępny od:
Merck Sharp & Dohme B.V.
Kod ATC:
V03AB35
INN (International Nazwa):
sugammadex
Grupa terapeutyczna:
All other therapeutic products
Dziedzina terapeutyczna:
Neuromuscular Blockade
Wskazania:
Reversal of neuromuscular blockade induced by rocuronium or vecuronium.For the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium-induced blockade in children and adolescents.
Podsumowanie produktu:
Revision: 22
Status autoryzacji:
Authorised
Data autoryzacji:
2008-07-25
Ulotka dla pacjenta
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET
: INFORMATION FOR THE
USER
BRIDION 100 MG/ML SOLUT
ION FOR INJECTI
ON
sugammadex
READ ALL O
F THIS LEAFLE
T CAREFULLY BEFORE YO
U ARE GI
VEN THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leafl
et. You may need to read it agai
n.
•
If y
ou have further questi
ons, ask your anaesthetist
or doctor.
•
If you get any side effects, ta
lk to your an
aesthetist or other d
octor. T
his includes any
possible
side effects not listed i
n this leaflet.
See section 4.
WHAT IS I
N THIS LEAFLET
1.
What Bridion
is and what it is use
d for
2.
What you need to kno
w before Bridion is given
3.
How Bridion is given
4.
Possible side effects
5.
How to store Bridion
6.
Conten
ts of the pack and other
information
1.
W
HAT BRIDION IS
AND WHAT IT IS USED FOR
WHAT BRIDION IS
Bridion contains the
active substance sugammadex.
Bridion is con
s
idered to be a
Selective Relaxant
Binding Agent since it only work
s with specific m
uscle rel
axants, rocuronium bromid
e or
vecuronium
bromide.
WHAT BR
IDION IS USED FOR
When you have
some ty
pes of operation
s, you
r muscles must be completely
relaxed. This m
akes it
easier for the su
rgeon to do t
he operation. For thi
s, the g
eneral anaestheti
c you are
given includes
medicines to
make your muscles relax. Thes
e are called
muscle relaxants
, and exam
ples include
rocuroniu
m bromide and vecuronium brom
ide. Because th
e
se medicines al
so make y
our breathing
muscles relax, you n
eed help
to breathe (arti
ficial ve
ntilation) during and aft
er y
our operation until you
can b
reathe on your own again.
Bridion is us
ed to speed up the rec
overy of your muscles after a
n operation to
a
llow you to bre
athe on
y
our own again
earlier. It does thi
s by com
bining with the r
ocuronium
bromide or vecuronium
bromid
e in your body. It can be use
d in adults whenever rocuronium
bromide
or vecuronium bromide
is used and in children and
adolescents (ag
e
d 2 to 17 years
) when ro
curonium brom
ide is used for a
moderate le
vel of rel
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bridion 100 mg/mL
solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL
contains sugammadex sodium equivalent to 100
mg sugammadex.
Each vial of
2 mL
contains sugammadex sodium equivalent to 200
mg sugammadex.
Each vial of
5 mL
contains sugammadex sodium equivalent to 500
mg sugammadex.
Excipient(s)
with known effect
Contains up to 9.7 mg/mL
sodium (see
section 4.4).
For the full lis
t of excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Solution for injection (injection).
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
THERAP
EUTIC INDICATIONS
Reversal of neuromuscular blockade induced by rocuronium or vecuronium
in adults.
For the paediatric population: sugammadex is only recommended for
routine reversal of rocuronium
induced bl
ockade in chil
dren and adolescents
aged 2 to 17 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Sugammadex should only be administered by, or under the supervision of
an anaesthetist.
The use of an appropriate neuromuscular monitoring techniq
ue is recommen
ded to monitor the
recovery of ne
uromuscular blockade
(see section 4.4).
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.
Sugam
madex can be u
sed to reverse different
levels o
f rocuronium or vecuronium induced
neuromuscular 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) following rocuro
nium or vecuro
nium induced blockade. M
edian tim
e 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 induced block
ade. Median time to
recovery of
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