Negara: Armenia
Bahasa: Inggris
Sumber: 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
2022-08-23
SUMMARY OF PRODUCT CHARACTERISTICS FOR MEDICAL USE OF DRUG 1. NAME OF THE MEDICINAL PRODUCT Bridion 100 mg/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1. Qualitative composition Sugammadex. 2.2 Quantitative composition Each vial of 2 mL contains _active substance_ : sugammadex sodium equivalent to 200 mg sugammadex. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the pediatric 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 anesthetist. 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 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 rocuronium when compared to ve Baca dokumen lengkapnya