BRIDION- sugammadex injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

SUGAMMADEX SODIUM (UNII: ERJ6X2MXV7) (SUGAMMADEX - UNII:361LPM2T56)

Verfügbar ab:

Medical Purchasing Solutions, LLC

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

BRIDION ® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex [see Warnings and Precautions (5.1), Adverse Reactions (6)] . Risk Summary There are no data on BRIDION use in pregnant women to inform any drug-associated risks. In animal reproduction studies, there was no evidence of teratogenicity following daily intravenous administration of sugammadex to rats and rabbits during organogenesis at exposures of up to 6 and 8 times, respectively, the maximum recommended human dose (MRHD) of 16 mg/kg. However, there was an increase in the incide

Produktbesonderheiten:

BRIDION (sugammadex) injection is a clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. BRIDION is available in the following presentations: The packaging of this product is not made with natural rubber latex. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Protect from light. When not protected from light, the vial should be used within 5 days.

Berechtigungsstatus:

New Drug Application

Fachinformation

BRIDION- SUGAMMADEX INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRIDION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BRIDION.
BRIDION (SUGAMMADEX) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
BRIDION is indicated for the reversal of neuromuscular blockade
induced by rocuronium bromide and
vecuronium bromide in adults undergoing surgery. ( 1)
DOSAGE AND ADMINISTRATION
Monitor for twitch responses to determine the timing and dose for
BRIDION administration. ( 2)
Administer as a single bolus injection. ( 2)
_For rocuronium and vecuronium:_
4 mg/kg is recommended if spontaneous recovery of the twitch response
has reached 1 to 2 post-
tetanic counts (PTC) and there are no twitch responses to
train-of-four (TOF) stimulation. ( 2.1)
2 mg/kg is recommended if spontaneous recovery has reached the
reappearance of the second twitch
in response to TOF stimulation. ( 2.1)
_For rocuronium only:_
16 mg/kg is recommended if there is a clinical need to reverse
neuromuscular blockade soon
(approximately 3 minutes) after administration of a single dose of 1.2
mg/kg of rocuronium. ( 2.1)
DOSAGE FORMS AND STRENGTHS
200 mg/2 mL (100 mg/mL) in a single-dose vial for bolus injection ( 3)
500 mg/5 mL (100 mg/mL) in a single-dose vial for bolus injection ( 3)
CONTRAINDICATIONS
Known hypersensitivity to sugammadex or any of its components. ( 4)
WARNINGS AND PRECAUTIONS
Anaphylaxis: Anaphylaxis has occurred in 0.3% of healthy volunteers.
Observe patients for an
appropriate period of time after administration. ( 5.1)
Marked Bradycardia: Cases of marked bradycardia, some of which have
resulted in cardiac arrest, have
been observed within minutes after administration. Monitor for
hemodynamic changes and administer
anticholinergic agents such as atropine if clinically significant
bradycardia is observed. ( 5.2)
Respiratory Function Monitoring: Ventilatory support is mand