Bridion 100mg/ml(200mg/2ml) 100 mg/ml

Country: Հորդանան

language: անգլերեն

source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

active_ingredient:

Sugammadex 100 mg/ml

MAH:

مستودع أدوية أداتكو - Adatco Drug Store

ATC_code:

V03AB35

INN:

Sugammadex 100 mg/ml

dosage:

100 mg/ml

units_in_package:

10 Vials of 2ml

manufactured_by:

Patheon Manufacturing Service LLC (امريكا)

PIL

BS 12_634
01
300712
485 x 435.5
MSD ARTWORK
401975539-0020
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Black
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Technical Info
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SUMMARY OF PRODUCT CHARACTERISTCS
1.
NAME OF THE MEDICINAL PRODUCT
Bridion® 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 (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 reap