Quốc gia: Jordan
Ngôn ngữ: Tiếng Anh
Nguồn: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Sugammadex 100 mg/ml
مستودع أدوية أداتكو - Adatco Drug Store
V03AB35
Sugammadex 100 mg/ml
100 mg/ml
10 Vials of 2ml
Patheon Manufacturing Service LLC (امريكا)
BS 12_634 01 300712 485 x 435.5 MSD ARTWORK 401975539-0020 N\A N\A N\A N/A N\A Black Glue Profile Technical Info N/A SUMMARY OF PRODUCT CHARACTERISTCS 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 Contains up to 9.7 mg/mL 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 reap Äá»c toà n bá»™ tà i liệu