Sugammadex Clonmel 100 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sugammadex sodium

Available from:

Clonmel Healthcare Ltd

ATC code:

V03AB35

INN (International Name):

Sugammadex sodium

Pharmaceutical form:

Solution for injection

Therapeutic area:

sugammadex

Authorization status:

Marketed

Authorization date:

2023-02-10

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX CLONMEL 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 Clonmel is and what it is used for
2. What you need to know before Sugammadex Clonmel is given
3. How Sugammadex Clonmel is given
4. Possible side effects
5. How to store Sugammadex Clonmel
6. Contents of the pack and other information
1. WHAT SUGAMMADEX CLONMEL IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX CLONMEL IS
Sugammadex Clonmel contains the active substance sugammadex.
Sugammadex Clonmel is considered
to be a
_Selective Relaxant Binding Agent_
since it only works with specific muscle relaxants, rocuronium
bromide or vecuronium bromide.
WHAT SUGAMMADEX CLONMEL 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 Clonmel 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

Summary of Product characteristics

Health Products Regulatory Authority
10 February 2023
CRN00CDVM
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sugammadex Clonmel 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.
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
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