देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
SUGAMMADEX SODIUM (UNII: ERJ6X2MXV7) (SUGAMMADEX - UNII:361LPM2T56)
Camber Pharmaceuticals, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
SUGAMMADEX - SUGAMMADEX INJECTION SUGAMMADEX - SUGAMMADEX INJECTION, SOLUTION CAMBER PHARMACEUTICALS, INC. ---------- 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 पूरा दस्तावेज़ पढ़ें