Sugammadex Rowex 100 mg/ml solution for injection

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Sugammadex sodium

Հասանելի է:

Rowex Ltd

ATC կոդը:

V03AB35

INN (Միջազգային անվանումը):

Sugammadex sodium

Դոզան:

100 milligram(s)/millilitre

Դեղագործական ձեւ:

Solution for injection

Թերապեւտիկ տարածք:

sugammadex

Հաստատման ամսաթիվը:

2021-04-23

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX ROWEX 100 MG/ML SOLUTION FOR INJECTION
sugammadex
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sugammadex Rowex is and what it is used for
2.
What you need to know before Sugammadex Rowex is given
3.
How Sugammadex Rowex is given
4.
Possible side effects
5.
How to store Sugammadex Rowex
6.
Contents of the pack and other information
1. WHAT SUGAMMADEX ROWEX IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX ROWEX IS
Sugammadex Rowex contains the active substance sugammadex. Sugammadex
Rowex is considered
to be a
_Selective Relaxant Binding Agent _
since it only works with specific muscle relaxants,
rocuronium bromide or vecuronium bromide.
WHAT SUGAMMADEX ROWEX 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 Rowex 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

Ապրանքի հատկությունները

Health Products Regulatory Authority
08 September 2022
CRN00CZK2
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sugammadex Rowex 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.
Excipients(s) with known effect
Contains up to 9,7 mg/ml sodium (see section 4.4).
For the full lists of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless to slightly yellow-brown solution, practically
free from visible particles.
The pH is between 7.0 and 8.0 and osmolality is between 300 and 500
mOsmol/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