Sugammadex 10 mg/ml solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sugammadex sodium

Available from:

Laboratoire AGUETTANT

ATC code:

V03AB35

INN (International Name):

Sugammadex sodium

Pharmaceutical form:

Solution for injection in pre-filled syringe

Therapeutic area:

sugammadex

Authorization status:

Not marketed

Authorization date:

2023-09-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUGAMMADEX 50 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
SUGAMMADEX 10 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
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 anaesthesist or doctor.
-
If you get any side effects, talk to your anaesthesist 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 Sugammadex is given
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
f

Summary of Product characteristics

Health Products Regulatory Authority
22 September 2023
CRN00D3FR
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sugammadex 10 mg/ml solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml prefilled syringe contains sugammadex sodium equivalent to
100 mg of sugammadex.
Each mL of solution for injection contains sugammadex sodium
equivalent to 10 mg sugammadex.
Excipient(s) with known effect"
"Contains 42.6 mg sodium per 10 ml prefilled syringe"
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear colourless to slightly yellow solution, free from visible
particles
pH: 7.0 – 8.0
Osmolality: 270 – 330 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SUGAMMADEX is indicated in 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.
The pre-filled syringe 100 mg/10 ml is more adapted to children and
adults weighing less than 50 kg.
In case of high doses or weights over 50 kg, other presentations or
formulations are available.
_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 T4/T