Država: Singapur
Jezik: angleščina
Source: HSA (Health Sciences Authority)
ALFENTANIL HCl EQV ALFENTANIL
ALLIANCE PHARM PTE. LTD.
N01AH02
0.5 mg/ml
INJECTION
ALFENTANIL HCl EQV ALFENTANIL 0.5 mg/ml
INTRAVENOUS
Prescription Only
GlaxoSmithKline (GSK) Manufacturing S.p.A.
ACTIVE
1990-05-03
[RAPIFEN] (15 July 2008) 1 NAME OF THE MEDICINAL PRODUCT TRADE NAME RAPIFEN NONPROPRIETARY NAMES Alfentanil Hydrochloride QUALITATIVE AND QUANTITATIVE COMPOSITION RAPIFEN is a sterile preservative-free, isotonic, aqueous solution containing alfentanil hydrochloride equivalent to 0.5 mg alfentanil per ml. The other ingredients are sodium chloride and water for injection. RAPIFEN (alfentanil) is supplied in 2 ml ampoules. PHARMACEUTICAL FORM RAPIFEN is a very short-acting potent narcotic analgesic for intravenous (I.V.) use. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS RAPIFEN is indicated for use as: - an anaesthetic induction agent. - a narcotic analgesic in general as well as adjuvant to regional anaesthesia and for both short (bolus injections) and long (bolus, supplemented by increments or by infusion) surgical procedures. Because of its rapid and short-lasting action, RAPIFEN is particularly suited as a narcotic analgesic for short procedures and outpatient surgery, but also as an analgesic supplement for procedures of medium and long duration, since periods of very painful stimuli can easily be overcome by small increments of RAPIFEN or by adapting its infusion rate. POSOLOGY AND METHOD OF ADMINISTRATION The dosage of RAPIFEN 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. In children it should be increased. 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 agent just before induction. Droperidol may be given to prevent nausea and vomiting. 1. For use as an induction agent An intravenous bolus dose of Preberite celoten dokument
. . . PRODUCT NAME RAPIFEN ® (alfentanil hydrochloride) DOSAGE FORMS AND STRENGTHS Sterile, preservative-free, isotonic aqueous solution containing alfentanil hydrochloride equivalent to 0.5mg alfentanil per mL. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS RAPIFEN is indicated for use as: - an anesthetic induction agent. - an opioid analgesic in general as well as an adjuvant to regional anesthesia and for both short (bolus injections) and long (bolus, supplemented by increments or by infusion) surgical procedures. Because of its rapid and short-lasting action, RAPIFEN is particularly suited as an opioid analgesic for short procedures and outpatient surgery, but also as an analgesic supplement for procedures of medium and long duration, since periods of very painful stimuli can usually be overcome by small increments of RAPIFEN or by adapting its infusion rate. DOSAGE AND ADMINISTRATION The dosage of RAPIFEN should be individualized according to age, body weight, physical status, underlying pathological condition, use of other drugs and type of surgery and anesthesia. The initial dose should be reduced in the elderly (> 65 years of age) and in debilitated patients. In children it should be increased. The effect of the initial dose should be taken into account in determining supplemental doses. To avoid bradycardia, a small intravenous (I.V.) dose of an anti-cholinergic agent just before anesthetic induction may be administered. DOSAGE _ADULTS_ _FOR USE AS AN ANESTHETIC INDUCTION AGENT_ An I.V. bolus dose of ≥120 mcg/kg (17 mL/70 kg) RAPIFEN will induce unconsciousness and analgesia while maintaining good cardiovascular stability in patients with adequate muscle relaxation. _FOR SHORT PROCEDURES AND USE IN OUTPATIENTS_ Small doses of RAPIFEN are most useful for minor, short surgical procedures and for outpatients, provided cardiopulmonary monitoring equipment is available. An I.V. bolus dose of 7 to 15 mcg/kg (1 to 2 mL/70 kg) is usually adequate for procedures lasting less than 10 Preberite celoten dokument