Sugagelan 100 mg/ml oplossing voor injectie

Država: Nizozemska

Jezik: nizozemščina

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktivna sestavina:

SUGAMMADEX NATRIUM 108 mg/ml SAMENSTELLING overeenkomend met ; SUGAMMADEX 100 mg/ml

Dostopno od:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

INN (mednarodno ime):

SUGAMMADEX NATRIUM 108 mg/ml SAMENSTELLING overeenkomend met ; SUGAMMADEX 100 mg/ml

Farmacevtska oblika:

Oplossing voor injectie

Sestava:

NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507)

Pot uporabe:

Intraveneus gebruik

Datum dovoljenje:

1900-01-01

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAGELAN 100 MG/ML OPLOSSING VOOR INJECTIE
sugammadex
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your anaesthetist or doctor.
-
If you get any side effects, talk to your anaesthetist or doctor. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sugagelan is and what it is used for
2.
What you need to know before Sugagelan is given
3.
How Sugagelan is given
4.
Possible side effects
5.
How to store Sugagelan
6.
Contents of the pack and other information
1
WHAT SUGAGELAN IS AND WHAT IT IS USED FOR
WHAT SUGAGELAN IS
Sugagelan contains the active substance sugammadex. Sugagelan is
considered to be a
_Selective Relaxant _
_Binding Agent _
since it only works with specific muscle relaxants, rocuronium bromide
or vecuronium
bromide.
WHAT SUGAGELAN IS USED FOR
When you have some types of operations, your muscles must be
completely relaxed. This makes it easier for
the surgeon to do the operation. For this, the general anaesthetic you
are given includes medicines to make
your muscles relax. These are called
_muscle relaxants_
, and examples include rocuronium bromide and
vecuronium bromide. Because these medicines also make your breathing
muscles relax, you need help to
breathe (artificial ventilation) during and after your operation until
you can breathe on your own again.
Sugagelan is used to speed up the recovery of your muscles after an
operation to allow you to breathe on your
own again earlier. It does this by combining with the rocuronium
bromide or vecuronium bromide in your
body. It can be used in adults whenever rocuronium bromide or
vecuronium bromide is used and in children
and adolescents (aged 2 to 17 years) when rocuronium bromide is used
for a moderate level of relaxation.
2
WHAT YOU NEED TO KNOW BEFORE SUGAGELAN IS GIVEN
YOU SHOULD N

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Sugagelan 100 mg/ml oplossing voor injectie
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
Each mL contains up to 9.7 mg sodium (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow brown solution, practically free
from particles.
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 adults.
For the paediatric population: sugammadex is only recommended for
routine reversal of rocuronium induced
blockade in children 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 technique is
recommended to monitor the
recovery of
neuromuscular 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.
Sugammadex can be used to reverse different levels of 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 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).
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 blockade. M