Ország: Örményország
Nyelv: angol
Forrás: 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 vial 2ml
Prescription
Registered
2021-07-26
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 lis t 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 PARTICULAR S 4.1 THERAP EUTIC 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 bl ockade in chil dren 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 techniq ue is recommen ded to monitor the recovery of ne uromuscular 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. Sugam madex can be u sed to reverse different levels o f 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 rocuro nium or vecuro nium induced blockade. M edian tim e 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 block ade. Median time to recovery of Olvassa el a teljes dokumentumot