国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
DESFLURANE
百特醫療產品股份有限公司 臺北市大安區敦化南路2段95號28樓 (12350071)
N01AB07
吸入用液劑
DESFLURANE (2804001800) ML
鋁瓶
製 劑
限由醫師使用
BAXTER HEALTHCARE CORPORATION ROUTE 3, KM. 144.2 GUAYAMA, PUERTO RICO 00784 PR
desflurane
吸入性全身麻醉劑。說明:麻醉誘導 Desflurane適用於成人在住院及門診手術誘導期之吸入性麻醉劑。禁用做為兒科病患誘導用之吸入性麻醉劑,因為它會導致中至重度的上呼吸道不良反應。 麻醉維持 適用於成人與兒科病患住院或門診手術之吸入性麻醉維持。若以本藥以外之吸入性麻醉來誘導與氣管插管,可用在小孩及嬰兒麻醉維持。不適用於非插管之幼童麻醉維持,因為極可能造成幼童之呼吸不良反應,包括:咳嗽、咽喉痙攣或刺激分泌產生。
有效日期: 2028/11/20; 英文品名: "Baxter" Suprane (Desflurane) Liquid for Inhalation
2018-11-20
HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SUPRANE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUPRANE. SUPRANE (DESFLURANE, USP) LIQUID, FOR INHALATION USE INITIAL U.S. APPROVAL: 1992 ----------------------------RECENT MAJOR CHANGES-------------------------- • Warnings and Precautions (5.7) 11/2016 ----------------------------INDICATIONS AND USAGE--------------------------- SUPRANE is an inhalation agent indicated: • for induction and/or maintenance of anesthesia in adults (1.1) • for maintenance of anesthesia in pediatric patients following induction with agents other than SUPRANE and intubation. ----------------------DOSAGE AND ADMINISTRATION----------------------- • SUPRANE should be administered only by persons trained in the administration of general anesthesia. It should only be administered using a vaporizer specifically designed and designated for use with SUPRANE. (2) • The administration of general anesthesia must be individualized based on the patient’s response, including cardiovascular and pulmonary changes. (2) • SUPRANE should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or where increases in heart rate or blood pressure are undesirable. (2.6) • Patients with intracranial space occupying lesions (2.7) ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Liquid (volatile): 100% (3) -------------------------------CONTRAINDICATIONS------------------------------ • Patients with known or suspected genetic susceptibility to malignant hyperthermia (4) • Patients in whom general anesthesia is contraindicated (4) • Induction of anesthesia in pediatric patients (4) • Patients with known sensitivity to halogenated agents (4, 5.5) • Patients with a history of moderate to severe hepatic dysfunction following anesthesia with halogenated agents and not otherwise explained. (4, 5.5) -----------------------WARNINGS AND PRECAUTIONS--------------- 阅读完整的文件