Sugammadex 100 mg/ml solution for injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Sugammadex

Tilgjengelig fra:

Reddy Holding GmbH

ATC-kode:

V03AB35

INN (International Name):

Sugammadex

Legemiddelform:

Solution for injection

Terapeutisk område:

sugammadex

Autorisasjon status:

Marketed

Autorisasjon dato:

2022-10-21

Informasjon til brukeren

1 PACKAGE LEAFLET: INFORMATION FOR THE USER SUGAMMADEX 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 is and what it is used for
2.
What you need to know before Sugammadex is given
3.
How Sugammadex is given
4.
Possible side effects
5.
How to store Sugammadex
6.
Contents of the pack and other information
1.
WHAT SUGAMMADEX IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX IS
Sugammadex contains the active substance sugammadex. Sugammadex is
considered to be a
_Selective _
_Relaxant Binding Agent _
since it only works with specific muscle relaxants, rocuronium bromide
or
vecuronium bromide.
WHAT SUGAMMADEX 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 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 SUGAMMADEX IS G

Preparatomtale

Health Products Regulatory Authority
18 October 2023
CRN00DNVN
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sugammadex 100 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 mg sugammadex (as sugammadex sodium).
Each vial of 2 ml contains 200 mg sugammadex (as sugammadex sodium).
Each vial of 5 ml contains 500 mg sugammadex (as sugammadex sodium).
Excipient(s) with known effect:
Each ml solution 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.
Clear and colourless to slightly yellow solution.
pH: Between 7 and 8
Osmolality: 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 T4/T1 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
re