Pajjiż: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sugammadex (sugammadex sodium)
N.V. Organon
V03AB35
sugammadex (sugammadex sodium)
100mg/ml
solution for i/v injection
(10) glass vials 2ml
Prescription
Registered
2023-07-12
1 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. 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 intravenous 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 (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 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 Aqra d-dokument sħiħ