Sugammadex Adroiq

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sugammadex sodium

Available from:

Extrovis EU Ltd.

ATC code:

V03, V03AB

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.

Product summary:

Revision: 1

Authorization status:

Authorised

Authorization date:

2023-05-26

Patient Information leaflet

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX ADROIQ 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 Adroiq is and what it is used for
2.
What you need to know before Sugammadex Adroiq is given
3.
How Sugammadex Adroiq is given
4.
Possible side effects
5.
How to store Sugammadex Adroiq
6.
Contents of the pack and other information
1.
WHAT SUGAMMADEX ADROIQ IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX ADROIQ IS
Sugammadex Adroiq 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 ADROIQ 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 Adroiq 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 us

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sugammadex Adroiq 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.
Excipients 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.
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
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