מדינה: סינגפור
שפה: אנגלית
מקור: HSA (Health Sciences Authority)
Sugammadex sodium 108.8mg eqv Sugammadex
MSD PHARMA (SINGAPORE) PTE. LTD.
V03AB35
100mg
INJECTION, SOLUTION
Sugammadex sodium 108.8mg eqv Sugammadex 100mg
INTRAVENOUS
Prescription Only
N.V. Organon
ACTIVE
2010-05-31
OS SmPC-MK8616-SOi-102013 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 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. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents. 4.2 Posology and method of administration 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. 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 recommende קרא את המסמך השלם
CCDS-MK8616-SOi-092020 bridion® Solution for injection 100 mg/ml 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 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 recommended to monitor the recovery of neuromuscular blockade. 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 median time to recovery of the T 4 /T 1 ratio to 0.9 of r קרא את המסמך השלם