Sugammadex Amomed

Pays: Union européenne

Langue: anglais

Source: EMA (European Medicines Agency)

Ingrédients actifs:

sugammadex sodium

Disponible depuis:

AOP Orphan Pharmaceuticals GmbH

Code ATC:

V03AB35

DCI (Dénomination commune internationale):

sugammadex

Groupe thérapeutique:

All other therapeutic products

Domaine thérapeutique:

Neuromuscular Blockade

indications thérapeutiques:

Reversal of neuromuscular blockade induced by rocuronium or vecuronium.For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Descriptif du produit:

Revision: 1

Statut de autorisation:

Authorised

Date de l'autorisation:

2023-01-10

Notice patient

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX AMOMED 100 MG/ML SOLUTION FOR INJECTION
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 further questions, ask your anaesthetist or doctor.
•
If you get any side effects, talk to your anaesthetist or other
doctor. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sugammadex Amomed is and what it is used for
2.
What you need to know before Sugammadex Amomed is given
3.
How Sugammadex Amomed is given
4.
Possible side effects
5.
How to store Sugammadex Amomed
6.
Contents of the pack and other information
1.
WHAT SUGAMMADEX AMOMED IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX AMOMED IS
Sugammadex Amomed contains the active substance sugammadex. Sugammadex
Amomed is
considered to be a selective relaxant binding agent
_ _
since it only works with specific muscle relaxants,
rocuronium bromide or vecuronium bromide.
WHAT SUGAMMADEX AMOMED 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.
Sugammadex Amomed 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 rocuroniu

Résumé des caractéristiques du produit

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sugammadex Amomed 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.
Excipient(s) with known
effect
Contains up to 9.4 mg/ml sodium (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and slightly yellow solution.
The pH is between 7 and 8 and osmolality is between 300 and 400
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
Sugammadex is subject to restricted medical prescription. 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).
Posology
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. Median time to
recovery of
the T
4
/T
1
ratio to 0.9 is around