Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Naloxone hydrochloride dihydrate 0.44 mg/mL equivalent to 0.40 mg naloxone hydrochloride
Max Health Limited
Naloxone hydrochloride dihydrate 0.44 mg/mL (equivalent to 0.40 mg naloxone hydrochloride)
400 mcg/mL
Solution for injection
Active: Naloxone hydrochloride dihydrate 0.44 mg/mL equivalent to 0.40 mg naloxone hydrochloride Excipient: Hydrochloric acid Sodium chloride Water for injection
Prescription
Sanofi Chimie
Naloxone hydrochloride Injection is indicated for the complete or partial reversal of narcotic depression, including respiratory depression, induced by opioids including natural and synthetic narcotics, propoxyphene, methadone and the narcotic antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride is also indicated for the diagnosis of suspected acute opioid overdosage.
Package - Contents - Shelf Life: Ampoule, glass, colourless neutral type I, nominal volume of 1ml - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, colourless neutral type I, nominal volume of 1ml - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
2015-02-24
NEW ZEALAND DATA SHEET 1. PRODUCT NAME NALOXONE HYDROCHLORIDE (Hameln) 400 micrograms/mL Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule of 1 mL contains naloxone hydrochloride 400 micrograms (0.4 mg) (as naloxone hydrochloride dihydrate). Excipient with known effect: 1 mL solution for injection/infusion contains 3.54 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless solution free from visible particulates. pH: 3.1 – 4.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Naloxone hydrochloride Injection is indicated for the complete or partial reversal of narcotic depression, including respiratory depression, induced by opioids including natural and synthetic narcotics, propoxyphene, methadone and the narcotic antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride is also indicated for the diagnosis of suspected acute opioid overdosage. 4.2 DOSE AND METHOD OF ADMINISTRATION Naloxone hydrochloride may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration and it is recommended in emergency situations. Since the duration of action of some narcotics may exceed that of naloxone hydrochloride the patient should be kept under continued surveillance and repeated doses of naloxone hydrochloride should be administered, as necessary. INTRAVENOUS INFUSION - Naloxone hydrochloride may be diluted for intravenous infusion in normal saline or 5% dextrose solutions. The addition of 2mg of naloxone hydrochloride in 500 mL of either solution provides a concentration of 0.004 mg/mL. Mixtures should be used within 24 hours. After 24 hours, the remaining unused solution must be discarded. The rate of administration should be titrated in accordance with the patient's response. Parenteral medicine products should be inspected visually for particulate matter and discolouration prior to administration Perskaitykite visą dokumentą