Sugammadex

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Sugammadex sodium

Mevcut itibaren:

Juta Pharma GmbH

ATC kodu:

V03AB35

INN (International Adı):

Sugammadex sodium

Farmasötik formu:

Solution for injection

Terapötik alanı:

sugammadex

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2023-07-21

Bilgilendirme broşürü

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

Ürün özellikleri

Health Products Regulatory Authority
24 July 2023
CRN00DFH8
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sugammadex Juta 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
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 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 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 Juta 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 Juta 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 rocu