Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Propofol 20 mg/mL
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Propofol 20 mg/mL
2% w/v
Emulsion for injection
Active: Propofol 20 mg/mL Excipient: Disodium edetate Egg lecithin Glycerol Lecithin Nitrogen Sodium hydroxide Soya oil Water for injection
Syringe, glass, prefilled, 10 mL
Prescription
Prescription
Bachem SA
· DIPRIVAN is a short-acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children >1 month. · DIPRIVAN may also be used for sedation of ventilated adult and paediatric patients >1 month receiving intensive care. · DIPRIVAN may also be used for monitored anaesthesia care sedation for surgical and diagnostic procedures in adults and children >1 month.
Package - Contents - Shelf Life: Syringe, glass, prefilled - 10 mL - 2 years from date of manufacture stored at or below 25°C - Syringe, glass, prefilled - 50 mL - 2 years from date of manufacture stored at or below 25°C - Vial, glass, - 50 mL - 2 years from date of manufacture stored at or below 25°C
1999-02-17
D IPRIVAN Data Sheet NEW ZEALAND DATA SHEET 1. PRODUCT NAME D IPRIVAN Propofol Injection 10 mg/mL (Diprivan 1%). Propofol Injection 20 mg/mL (Diprivan 2%). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Diprivan contains 10 mg or 20 mg propofol per 1 mL. For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Diprivan is a white, aqueous and isotonic emulsion for intravenous injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS D IPRIVAN is a short-acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children >1 month. D IPRIVAN may also be used for sedation of ventilated adult and paediatric patients >1 month receiving intensive care. D IPRIVAN may also be used for monitored anaesthesia care sedation for surgical and diagnostic procedures in adults and children >1 month. 4.2 DOSE AND METHOD OF ADMINISTRATION FOR GENERAL ANAESTHESIA OR MONITORED ANAESTHESIA CARE (MAC) SEDATION, D IPRIVAN SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION OF GENERAL ANAESTHESIA AND NOT INVOLVED IN THE CONDUCT OF THE SURGICAL/DIAGNOSTIC PROCEDURE. PATIENTS SHOULD BE CONTINUOUSLY MONITORED, AND FACILITIES FOR MAINTENANCE OF A PATENT AIRWAY, ARTIFICIAL VENTILATION, AND OXYGEN ENRICHMENT AND CIRCULATORY RESUSCITATION MUST BE IMMEDIATELY AVAILABLE. FOR SEDATION OF INTUBATED, MECHANICALLY VENTILATED ADULT PATIENTS IN THE INTENSIVE CARE UNIT (ICU), D IPRIVAN SHOULD BE ADMINISTERED ONLY BY PERSONS SKILLED IN THE MANAGEMENT OF CRITICALLY ILL PATIENTS AND TRAINED IN CARDIOVASCULAR RESUSCITATION AND AIRWAY MANAGEMENT. D IPRIVAN has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking medicines, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered. Lower doses of D IPRIVAN may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques. D IPRIVAN Data Sheet Copyright 2 For specific guidance relating to read_full_document