SUGAMMADEX- sugammadex injection SUGAMMADEX- sugammadex injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Camber Pharmaceuticals, Inc.

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.  Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.’s Bridion ® (Sugammadex Injection). However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Sugammadex 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 clinical trial data on sugammadex use in pregnant women to inform any drug-associated risks. The available data from

Proizvod sažetak:

Sugammadex injection is a clear, colorless to slightly yellow-brown color solution for intravenous infusion. Sugammadex injection is available in the following presentations:  •Sugammadex injection 2 mL single-dose vials containing 200 mg sugammadex (100 mg/mL)  Carton of 10                                      NDC 31722-254-10 Single-dose Vials                              NDC 31722-254-31 • Sugammadex injection 5 mL single-dose vials containing 500 mg sugammadex (100 mg/mL)  Carton of 10                                     NDC 31722-255-10 Single-dose Vials                             NDC 31722-255-31 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. Discard unused portion.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

SUGAMMADEX - SUGAMMADEX INJECTION
SUGAMMADEX - SUGAMMADEX INJECTION, SOLUTION
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUGAMMADEX INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUGAMMADEX INJECTION.
SUGAMMADEX INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
Sugammadex injection is indicated for the reversal of neuromuscular
blockade induced by rocuronium
bromide and vecuronium bromide in adults undergoing surgery. (1) (1)
DOSAGE AND ADMINISTRATION
• Dosing is based on actual body weight ( 2.1)
• Monitor for twitch responses to determine the timing and dose for
sugammadex injection administration.
( 2.1)
• Administer as a single bolus injection. ( 2.1)
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. ( 2.2)
• 2 mg/kg is recommended if spontaneous recovery has reached the
reappearance of the second twitch in
response to TOF stimulation. ( 2.2)
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. ( 2.2)
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: Be prepared for hypersensitivity reactions (including
anaphylactic reactions) and take
necessary precautions. ( 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 s