البلد: أندونيسيا
اللغة: الإندونيسية
المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SUGAMMADEX
ORGANON PHARMA INDONESIA TBK - Indonesia
SUGAMMADEX
100 MG
INJEKSI
DUS, 10 VIAL @ 2 ML
PATHEON MANUFACTURING SERVICES, LLC - United States of America
2021-06-17
BRIDION Sugammadex Solution for injection 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. 2 ml contains sugammadex sodium equivalent to 200 mg sugammadex. 5 ml contains sugammadex sodium equivalent to 500 mg sugammadex. For a full list of excipients, see section 6.1. Excipient(s): Each ml contains up to 9.7 mg sodium (see section 4.4). 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 patients 2 years of age and older. 4.2 Posology and method of administration Sugammadex should only be administered by, or under the supervision of an anesthetist. The use of an appropriate neuromuscular monitoring technique is DISETUJUI OLEH BPOM: 19/01/2023 ID: EREG10037312100021 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 anesthetic 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 /T 1 ratio to 0.9 is around 2 minutes (see section 5.1). Using the recommended doses for routine reversal will result in a slightly faster m اقرأ الوثيقة كاملة