Country: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 5 AMPUL @ 10 ML
2021-04-22
1 | P a g e PRODUCT NAME SUFENTA TRADEMARK _ _ Sufentanil citrate DOSAGE FORMS AND STRENGTHS SUFENTA is a sterile, preservative-free, isotonic aqueous solution for intravenous or epidural use. SUFENTA contains an amount of sufentanil citrate that is equivalent to 5 mcg sufentanil per mL. For excipients, see List of Excipients. CLINICAL INFORMATION INDICATIONS Intravenous SUFENTA is used both as an analgesic adjunct to nitrous oxide/oxygen and as a sole anesthetic in ventilated patients. It is particularly suitable for longer and more painful interventions where a potent analgesic is required to help maintain good cardiovascular stability. SUFENTA is also suited for epidural administration in spinal anesthesia. _Intravenous SUFENTA is indicated: _ -as an analgesic adjunct during induction and maintenance of balanced general anesthesia -as an anesthetic agent for induction and maintenance of anesthesia in patients undergoing major surgical procedures. _Epidural SUFENTA is indicated: _ -for the postoperative management of pain following general surgery, thoracic or orthopedic procedures and caesarean section. -as an analgesic adjunct to epidural bupivacaine during labor and vaginal deliveries. DOSAGE AND ADMINISTRATION The dosage of SUFENTA should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs, and type of surgical procedure and anesthesia. The effect of the initial dose should be taken into account in determining supplemental doses. INTRAVENOUS ADMINISTRATION To avoid bradycardia it is recommended to administer a small intravenous dose of an anti-cholinergic just before induction. _USE AS ANALGESIC ADJUNCT _ In patients undergoing general surgery, doses of SUFENTA of 0.5-5 mcg/kg provide intense analgesia, reducing the sympathetic response to surgical stimulation and preserving cardiovascular stability. The duration of activity is dose- dependent. A dose of 0.5 mcg/kg may be expected to last 50 minutes. Supplemental doses of 10-25 mcg should b Aqra d-dokument sħiħ