Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Alfentanil hydrochloride 0.544 mg/mL equivalent to alfentanil 0.5mg/mL
Medsurge Pharma Limited
5 mg/10mL
Solution for injection
Active: Alfentanil hydrochloride 0.544 mg/mL equivalent to alfentanil 0.5mg/mL Excipient: Sodium chloride Sodium hydroxide Water for injection
Class B3 Controlled Drug
Alfentanil injection is indicated in adults and children aged above one year for use as: · an opioid analgesic in general or regional anaesthesia for both short (bolus injections) and long (bolus, supplemented by increments or by continuous infusion) surgical procedures. · an anaesthetic induction agent. Due to its rapid and short-lasting action, Alfentanil injection is particularly suited as an opioid analgesic for short procedures and outpatient surgery. It is also useful 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 Alfentanil injection or by adapting its infusion rate.
Package - Contents - Shelf Life: Ampoule, glass, type I colourless, 10 mL - 1 dose units - 48 months from date of manufacture stored at or below 25°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, type I colourless, 10 mL - 5 dose units - 48 months from date of manufacture stored at or below 25°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Ampoule, glass, type I colourless, 10 mL - 10 dose units - 48 months from date of manufacture stored at or below 25°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)
2019-11-25
ALFENTANIL X MG/Y ML NEW ZEALAND DATA SHEET New Zealand Data Sheet Edition 2.0 – November 2021 Page 1 of 13 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Alfentanil 1 mg/2 mL MEDICIANZ Alfentanil 5 mg/10 mL MEDICIANZ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of Alfentanil solution for injection contains 0.544 mg/mL of alfentanil hydrochloride, equivalent to 0.5 mg/mL of alfentanil base. It is available as a sterile solution of alfentanil hydrochloride equivalent to 0.5 mg/mL alfentanil with 9.0 mg sodium chloride in water for injection to 1 mL. Each 2 mL ampoule contains 1.0 mg of alfentanil (as hydrochloride). Each 10 mL ampoule contains 5.0 mg of alfentanil (as hydrochloride). Excipient(s) with known effect: sodium chloride 9.0 mg/mL For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection Medicianz Alfentanil injection is a clear colourless solution. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Alfentanil injection is indicated in adults and children aged above one year for use as: • an opioid analgesic in general or regional anaesthesia for both short (bolus injections) and long (bolus, supplemented by increments or by continuous infusion) surgical procedures. • an anaesthetic induction agent. Due to its rapid and short-lasting action, Alfentanil injection is particularly suited as an opioid analgesic for short procedures and outpatient surgery. It is also useful 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 Alfentanil injection or by adapting its infusion rate. 4.2 Dose and method of administration Alfentanil injection should be administered intravenously. Other routes of administration have not been evaluated. The dosage of Alfentanil injection should be individualised according to age, body weight, physical status, underlying pathological condition, use of other medicines, type of anaesthesia and type and duration of the surgical Preberite celoten dokument