Sugammadex Synthon 100 mg/mL solution for injection - 5ml vial

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SUGAMMADEX

Available from:

Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands

ATC code:

V03AB35

INN (International Name):

SUGAMMADEX 100 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SUGAMMADEX 100 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2020-11-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX SYNTHON 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 doctor. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sugammadex Synthon is and what it is used for
2.
What you need to know before Sugammadex Synthon is given
3.
How Sugammadex Synthon is given
4.
Possible side effects
5.
How to store Sugammadex Synthon
6.
Contents of the pack and other information
1
WHAT SUGAMMADEX SYNTHON IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX SYNTHON IS
Sugammadex Synthon contains the active substance sugammadex.
Sugammadex Synthon is considered to
be a
_Selective Relaxant Binding Agent _
since it only works with specific muscle relaxants, rocuronium
bromide or vecuronium bromide.
WHAT SUGAMMADEX SYNTHON 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 Synthon 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sugammadex Synthon 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
Each mL contains up to 9.7 mg sodium (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless to slightly yellow brown solution, practically free
from particles.
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 induced blockade. M