Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
sugammadex sodium, Quantity: 544 mg (Equivalent: sugammadex, Qty 500 mg)
Teva Pharma Australia Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide
Intravenous
10 vials
(S4) Prescription Only Medicine
Reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.
Visual Identification: A clear, colourless to slightly yellow-brown solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2023-03-28
Sugammadex-Teva V1.0 1 AUSTRALIAN PRODUCT INFORMATION SUGAMMADEX-TEVA (SUGAMMADEX) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Sugammadex (as sodium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUGAMMADEX-TEVA 200 mg/2 mL solution for injection contains 200 mg sugammadex (as sodium) in 2 mL solution. SUGAMMADEX-TEVA 500 mg/5 mL solution for injection contains 500 mg sugammadex (as sodium) in 5 mL solution. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM SUGAMMADEX-TEVA 200 mg/2 mL and 500 mg/5 mL are a clear, colourless to slightly yellow-brown solution for injection. The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg. 4 CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older. DOSE AND METHOD OF ADMINISTRATION The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. Adequacy of the reversal of the neuromuscular block needs to be based on a clinical assessment of the patient and not train-of-four responses alone, unless quantitative (numeric) assessment is made of neuromuscular function. Patients should be monitored for clinical signs of residual blockade (e.g. difficulty maintaining a patent airway, generalised weakness, inadequate ventilatory effort) following cessation of the anaesthetic and extubation. The recommended dose of sugammadex depends on the level of neuromuscular blockadeto be reversed. The recommended dose does not depend on the anaesthetic regimen. ADULTS Sugammadex can be used to reverse different levels of rocuronium or vecuronium-induced neuromuscular blockade: _ROUTINE REVERSAL_ A dose of 4.0 mg/kg sugammadex is recommended if recovery has reached 1 - 2 post-tetanic counts (PTC) Sugammadex-Teva V1.0 2 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 PHARMACODYNAMIC PROPERT Đọc toàn bộ tài liệu