Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
NALOXONE HYDROCHLORIDE
Bristol-Myers Squibb Pharmaceuticals Ltd
NALOXONE HYDROCHLORIDE
20/1 Microgram/ML
Solution for Injection
Withdrawn
2007-07-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Narcan Neonatal 20 micrograms/ml, Solution for Injection or Infusion 2 ml Ampoule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of solution contains 20 micrograms naloxone hydrochloride. Each 2 ml-ampoule of solution contains 40 micrograms naloxone hydrochloride. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear, colourless to faintly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Narcan Neonatal is indicated for the complete or partial reversal of opioid-induced depression and other CNS depression in the new-born resulting from the administration of analgesics to the mother during childbirth. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Narcan Neonatal is for intravenous, intramuscular or subcutaneous injection or intravenous infusion. Intravenous infusion: Narcan 0.4mg/ml, may be diluted for intravenous infusion in normal saline (0.9%) or 5% dextrose in water or saline: the addition of 2 mg of Narcan in 500 ml of either solution provides a concentration of 4 micrograms/ml. Mixtures should be used within 12 hours. After 12 hours the remaining unused solution must be discarded. The rate of administration should be titrated in accordance with the patient's response to both the Narcan infusion and to any previous bolus doses administered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. An adequate airway should be established in the apnoeic infant before naloxone hydrochloride is administered. The usual dose for opioid-induced depression is 10 micrograms/kg body weight administered i.v., i.m., or s.c. If the desired degree of counteraction Pročitajte cijeli dokument