Bridion 100mg/ml solution for i/v injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sugammadex (sugammadex sodium)

Available from:

N.V. Organon

ATC code:

V03AB35

INN (International Name):

sugammadex (sugammadex sodium)

Dosage:

100mg/ml

Pharmaceutical form:

solution for i/v injection

Units in package:

(10) glass vial 2ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-05-15

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
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
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 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 reappearance of T
2
following rocuronium or vecuronium induced blockade. Median time to
recovery of the T
4