Land: Armenien
Språk: engelska
Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
propofol
DongKook Pharmaceutical Co.
propofol
10mg/ml
emulsion for i/v injection
Prescription
Dongkook I P H A R M A C E U T I C A L DONGKOOK PHARMACEUTICAL CO., LTD (P.O.365-834) 488-5 Jukhyeon-ri, Gwanghyewon-myeon, Jincheon-gun, Choongcheongbuk-do, Korea. Tel. 82-43-530-0300 Fax. 82-43-535-0125 www.dkpharm.co.kr SMPC FOR POFOL 1% INJECTION 1. Name of the medicinal product Pofol 10 mg/ml (1%) emulsion for injection 2. Qualitative and quantitative composition EACH ML CONTAINS _*Active ingredients _ Propofol………………………10,0mg _*Inactive ingredients _ Soy-bean oil, refined………...100mg Purified egg phosphatide……..12mg Glycerol………………………22,5mg Sodium hydroxide…………...0,08mg Water for injection………………....q.s. 3. Pharmaceutical form White to almost white emulsion for injection 4. Clinical particulars 4.1 Therapeutic indications Induction and maintenance of general anesthesia, sedation of ventilated patients receiving intensive care. 4.2 Posology and method of administration _1. INDUCTION OF GENERAL ANESTHESIA_ (1) Adults It is recommended that Pofol should be titrated (approximately 40mg[4ml] every 10 seconds in an average healthy adult) against the response of the patient until the clinical signs show the onset of anesthesia. Most adult patients aged less than 55 years are likely to require 1.5 to 2.5 mg/kg of Pofol, reduce rates of administration (20-50mg/min) to decrease total amount of administration. The total dose required can be reduced by lower rates of administration [20 -50 mg/min (2 - 5 ml/min)]. Over 55 years of age, the requirement will generally be less. In patients of ASA(American Society Anesthesiologist) grades 3 and 4, lower rates of administration should be used (approximately 20mg[2ml] every 10 seconds). (2) Children over 3 years of age. It is recommended that Pofol should be given slowly until the clinical signs show the onset of anesthesia. The dose should be adjusted for age and/or weight. Most patients over 8 years of age are likely to require approximately 2.5 mg/kg of Pofol for induction of anesthesia. Under this age the requi Läs hela dokumentet