Sugammadex Fresenius Kabi
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
21-07-2022
Summary of Product characteristics
(SPC)
21-07-2022
Public Assessment Report
(PAR)
21-07-2022
Active ingredient:
sugammadex sodium
Available from:
Fresenius Kabi Deutschland GmbH
ATC code:
V03AB35
INN (International Name):
sugammadex
Therapeutic group:
All other therapeutic products
Therapeutic area:
Neuromuscular Blockade
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.
Authorization status:
Authorised
Authorization date:
2022-07-15
Patient Information leaflet
30
B.
PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX FRESENIUS KABI 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 Fresenius Kabi is and what it is used for
2.
What you need to know before Sugammadex Fresenius Kabi is given
3.
How Sugammadex Fresenius Kabi is given
4.
Possible side effects
5.
How to store Sugammadex Fresenius Kabi
6.
Contents of the pack and other information
1.
WHAT SUGAMMADEX FRESENIUS KABI IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX FRESENIUS KABI IS
Sugammadex Fresenius Kabi 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 FRESENIUS KABI 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
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sugammadex Fresenius Kabi100 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains sugammadex sodium equivalent to 100 mg sugammadex.
Each vial of 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 list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless to slightly yellow solution, free from visible
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).
3
A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery
has occurred
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