Sugammadex Aspen 100 mg/mL solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sugammadex sodium

Available from:

Aspen Pharma Trading Limited

ATC code:

V03AB35

INN (International Name):

Sugammadex sodium

Pharmaceutical form:

Solution for injection

Therapeutic area:

sugammadex

Authorization status:

Not marketed

Authorization date:

2023-01-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX ASPEN 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 Aspen is and what it is used for
2. What you need to know before Sugammadex Aspen
is given
3. How Sugammadex Aspen
is given
4. Possible side effects
5. How to store Sugammadex Aspen
6. Contents of the pack and other information
1. WHAT SUGAMMADEX ASPEN IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX ASPEN IS
Sugammadex Aspen
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 ASPEN 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 Aspen
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 o

Summary of Product characteristics

HealthŸProductsŸRegulatoryŸAuthority
13ŸJanuaryŸ2023
CRN00CW3P
PageŸ1ŸofŸ13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SugammadexŸAspenŸ100Ÿmg/mLŸsolutionŸforŸinjection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ŸmLŸcontainsŸsugammadexŸsodiumŸequivalentŸtoŸ100ŸmgŸsugammadex.
EachŸvialŸofŸ2ŸmLŸcontainsŸsugammadexŸsodiumŸequivalentŸtoŸ200ŸmgŸsugammadex.
EachŸvialŸofŸ5ŸmLŸcontainsŸsugammadexŸsodiumŸequivalentŸtoŸ500ŸmgŸsugammadex.
Excipient with known effect
TheŸtotalŸamountŸofŸsodiumŸinŸeachŸmLŸisŸupŸtoŸ9.5ŸmgŸsodium.
ForŸtheŸfullŸlistŸofŸexcipients,ŸseeŸsectionŸ6.1.
3 PHARMACEUTICAL FORM
SolutionŸforŸinjectionŸ(injection).
ClearŸandŸcolourlessŸtoŸslightlyŸyellow/brownŸsolutionŸfreeŸfromŸvisibleŸparticles.
TheŸpHŸisŸbetweenŸ7ŸandŸ8ŸandŸosmolalityŸisŸbetweenŸ300ŸandŸ500ŸmOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ReversalŸofŸneuromuscularŸblockadeŸinducedŸbyŸrocuroniumŸorŸvecuroniumŸinŸadults.
ForŸtheŸpaediatricŸpopulation:ŸsugammadexŸisŸonlyŸrecommendedŸforŸroutineŸreversalŸofŸrocuroniumŸinducedŸblockadeŸinŸ
childrenŸandŸadolescentsŸagedŸ2ŸtoŸ17Ÿyears.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
SugammadexŸshouldŸonlyŸbeŸadministeredŸby,ŸorŸunderŸtheŸsupervisionŸofŸanŸanaesthetist.
TheŸuseŸofŸanŸappropriateŸneuromuscularŸmonitoringŸtechniqueŸisŸrecommendedŸtoŸmonitorŸtheŸrecoveryŸofŸneuromuscularŸ
blockadeŸ(seeŸsectionŸ4.4).
TheŸrecommendedŸdoseŸofŸsugammadexŸdependsŸonŸtheŸlevelŸofŸneuromuscularŸblockadeŸtoŸbeŸreversed.
TheŸrecommendedŸdoseŸdoesŸnotŸdependŸonŸtheŸanaestheticŸregimen.
SugammadexŸcanŸbeŸusedŸtoŸreverseŸdifferentŸlevelsŸofŸrocuroniumŸorŸvecuroniumŸinducedŸneuromuscularŸblockade:
_ _
_Adults_
Routine reversal:
AŸdoseŸofŸ4Ÿmg/kgŸsugammadexŸisŸrecommendedŸifŸrecoveryŸhasŸreachedŸatŸleastŸ1-2Ÿpost-tetanicŸcountsŸ(PTC)ŸfollowingŸ
rocuroniumŸorŸv