国家: 印度尼西亚
语言: 印度尼西亚文
来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FENTANYL CITRATE
KIMIA FARMA Tbk. - Indonesia
FENTANYL CITRATE
0.0785 MG
INJEKSI
DUS, 5 AMPUL @ 2 ML
DEMO S.A. PHARMACEUTICAL INDUSTRY - Greece
2021-10-25
Page 1 of 10 FENTANEX _fentanyl_ DOSAGE FORMS AND STRENGTHS Fentanyl is a sterile, preservative-free, isotonic aqueous solution for intravenous use. Each mL contains 50 mcg fentanyl (_as fentanyl citrate_). For excipients, _see List of Excipients_. CLINICAL INFORMATION INDICATIONS Fentanyl is indicated: For use as an opioid analgesic supplement in general or regional anaesthesia. For administration with a neuroleptic as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia. For use as an anaesthetic agent with oxygen in selected high-risk patients undergoing major surgery. DOSAGE AND ADMINISTRATION DOSAGE The dosage of Fentanyl should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs, and type of surgery and anaesthesia. The initial dose should be reduced in the elderly and in debilitated patients. The effect of the initial dose should be taken into account in determining supplemental doses. To avoid bradycardia, it is recommended to administer a small intravenous dose of an anti-cholinergic just before induction._ _ _Use as an analgesic supplement to general anaesthesia _ Low dose: 2 µg/kg Fentanyl in small doses is most useful for minor, surgery. Moderate dose: 2-20 µg/kg Where surgery becomes more complicated, a larger dose will be required. The duration of activity is dependent on dosage. High dose: 20-50 µg/kg During major surgical procedures, in which surgery is longer, and during which the stress response would be detrimental to the well-being of the patient, doses of 20-50 µg/kg of Fentanyl with nitrous oxide/oxygen have been shown to have an attenuating effect. When doses in this range have been used during surgery, post- operative ventilation and observation are essential in view of the possibility of extended post-operative respiratory depression. Supplemental doses of 25-250 µg (0.5-5 mL) should be tailored to the needs of the patient and to the 阅读完整的文件