SUMABID 100 IV INJECTION

Država: Južnoafrička Republika

Jezik: engleski

Izvor: South African Health Products Regulatory Authority (SAHPRA)

Dostupno od:

Ranbaxy (SA) (Pty) Ltd

Doziranje:

See ingredients

Farmaceutski oblik:

INJECTION

Sastav:

EACH 1,0 ml SOLUTION CONTAINS SUGAMMADEX SODIUM 100,0 mg

Status autorizacije:

Registered

Uputa o lijeku

1.3.2
Page
1
of
8
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
SUMABID 100 IV
100 mg/mL solution for injection
(sugammadex)
(Sugar free)
This product contains 9,7 mg sodium (see section 6)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN SUMABID.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or other
health care provider.
WHAT IS IN THIS LEAFLET
1.
What SUMABID is and what it is used for
2.
What you need to know before you are given SUMABID
3.
How to use SUMABID
4.
Possible side effects
5.
How to store SUMABID
6.
Contents of the pack and other information
1. WHAT SUMABID IS AND WHAT IT IS USED FOR
WHAT
SUMABID IS
SUMABID
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
SUMABID IS USED FOR
1.3.2
Page
2
of
8
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 ≥7 years) when rocuronium bromide is used for a
moderate level of
relaxation.
2. WHAT YOU NEED TO KNOW BEFORE SUMABID IS GIVEN TO YOU
SUMABID should not be given to you:

If you are hypersensitive (allergic

Svojstava lijeka

Page
1
of
15
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
SUMABID 100 IV
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains sugammadex (as octasodium) equivalent to 100 mg
sugammadex.
Each 2mL vial contains sugammadex (as octasodium) equivalent to 200 mg
sugammadex
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.
Clear, colourless to slightly yellow brown solution, practically free
from particles in a
colourless type I glass (2 mL) vial with a rubber stopper and alu-cap
with orange flip top.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SUMABID is indicated for the routine reversal of neuromuscular
blockade induced by
rocuronium or vecuronium. SUMABID is also indicated for the immediate
reversal of
neuromuscular blockade at 3 minutes after administration of
rocuronium. For the
paediatric population, SUMABID is only recommended for routine
reversal of rocuronium
induced blockade in children above 7 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
SUMABID injection should be administered under the supervision of an
anaesthetist.
SUMABID injection should be administered intravenously as a single
bolus injection. The
bolus injection may be given rapidly, within 10 seconds, directly into
a vein or into an
existing IV line.
SUMABID can be injected into the intravenous line of a running
infusion with the following
intravenous solutions: Sodium chloride 9 mg/mL (0,9 %), glucose 50
mg/mL (5 %), sodium
chloride 4,5 mg/mL (0,45 %) and glucose 25 mg/mL (2,5 %), Ringer's
lactate solution,
Ringer's solution, glucose 50 mg/mL (5 %) in sodium chloride 9 mg/mL
(0,9 %). For
paediatric patients SUMABID can be diluted using sodium chloride 9
mg/mL (0,9 %) to a
concentration of 10 mg/mL.
Page
2
of
15
Sugammadex has only been administered as a single bolus injection in
reported clinical
studies.
The use of an appropriate neuromuscular monitoring technique is
recommended to
moni