Sugammadex 100 mg/ml Solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sugammadex sodium

Available from:

Noridem Enterprises Limited

ATC code:

V03AB35

INN (International Name):

Sugammadex sodium

Pharmaceutical form:

Solution for injection

Therapeutic area:

sugammadex

Authorization status:

Not marketed

Authorization date:

2022-07-29

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 any 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 you are given Sugammadex
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 T

Summary of Product characteristics

Health Products Regulatory Authority
29 July 2022
CRN00C3PG
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 solution for injection contains sugammadex sodium equivalent to
100 mg sugammadex.
Each ampoule of 2 ml contains sugammadex sodium equivalent to 200 mg
sugammadex.
Each ampoule of 5 ml contains sugammadex sodium equivalent to 500 mg
sugammadex.
Excipient with known effect
Each ml contains 9.19 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless to slightly yellow solution.
pH: 7.00 - 8.00
Omolality: 300 – 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).
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 t