Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
NALOXONE HYDROCHLORIDE
Bristol-Myers Squibb Pharmaceuticals Ltd
NALOXONE HYDROCHLORIDE
1 Mg/Ml
Solution for Injection
Withdrawn
2007-06-09
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Narcan 1 mg/ml Solution for Injection or Infusion 2 ml Ampoule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of solution contains 1 milligram naloxone hydrochloride. Each 2 ml-ampoule of solution contains 2 milligrams 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 may be used for the complete or partial reversal of opioid depression, including mild to severe respiratory depression induced by natural and synthetic opioids, including dextropropoxyphene, methadone and certain mixed agonist/antagonist analgesics: nalbuphine and pentazocine. It may also be used for the diagnosis of suspected acute opioid overdosage. Narcan Neonatal may be used to counteract respiratory and other CNS depression in the newborn resulting from the administration of analgesics to the mother during childbirth. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Narcan is for intravenous, intramuscular or subcutaneous injection or intravenous infusion. Intravenous infusion: Narcan 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 an Прочитать полный документ