SUFENTA

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unités en paquet:

DUS, 5 AMPUL @ 10 ML

Date de l'autorisation:

2021-04-22

Résumé des caractéristiques du produit

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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