Sugammadex Piramal

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sugammadex sodium

Available from:

Piramal Critical Care B.V.

ATC code:

V03AB35

INN (International Name):

sugammadex

Therapeutic group:

sugammadex

Therapeutic area:

Neuromuscular Blockade

Therapeutic indications:

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.

Authorization status:

Authorised

Authorization date:

2023-06-23

Patient Information leaflet

28
B.
PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUGAMMADEX PIRAMAL 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 Piramal is and what it is used for
2.
What you need to know before Sugammadex Piramal is given
3.
How Sugammadex Piramal is given
4.
Possible side effects
5.
How to store Sugammadex Piramal
6.
Contents of the pack and other information
1.
WHAT SUGAMMADEX PIRAMAL IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX PIRAMAL IS
Sugammadex Piramal contains the active substance sugammadex.
Sugammadex Piramal is considered to
be a selective relaxant binding agent since it only works with
specific muscle relaxants, rocuronium
bromide or vecuronium bromide.
WHAT SUGAMMADEX PIRAMAL 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 Piramal 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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sugammadex Piramal 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
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 brown 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
re