국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Morphine sulfate pentahydrate 1 mg/mL;
Biomed Limited
Morphine sulfate pentahydrate 1 mg/mL
1 mg/mL
Solution for injection
Active: Morphine sulfate pentahydrate 1 mg/mL Excipient: Sodium chloride Water for injection
Bag, plastic, Propyflex with polycarbonate port and rubber stopper, 100 mL
Class B1 Controlled Drug
Class B1 Controlled Drug
Siegfried Ltd
Morphine sulfate is indicated for the relief of moderate to severe pain not responsive to non-opioidanalgesics. It may also be used as a pre-operative medication and as an analgesic adjunct in general anaesthesisia. Morphine sulphate is indicated in palliative care for the treatment of diarrhoea and intractable cough.
Package - Contents - Shelf Life: Bag, plastic, flexible non-PVC polypropylene IV bag with foil overwrap - 100 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze. - Syringe, - 10 mL - 10 months from date of manufacture stored at or below 25°C protect from light - Syringe, - 30 mL - 10 months from date of manufacture stored at or below 25°C - Syringe, - 50 mL - 10 months from date of manufacture stored at or below 25°C
1997-04-14
NEW ZEALAND DATA SHEET MORPHINE SULFATE (BIOMED) 1 MG/ML SOLUTION FOR INJECTION Page 1 of 17 1 PRODUCT NAME Morphine Sulfate (Biomed) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Morphine Sulfate Pentahydrate 1 mg/mL Solution for Injection For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Clear, colourless or almost colourless solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Morphine sulfate is indicated for the relief of moderate to severe pain not responsive to nonopioid analgesics. It may also be used as a pre-operative medication and as an analgesic adjunct in general anaesthesia. Morphine sulfate is indicated in palliative care for the treatment of diarrhoea and intractable cough. 4.2 DOSE AND METHOD OF ADMINISTRATION Note: Opioid antagonists and facilities for administration of oxygen and control of respiration should be available during, and immediately following parenteral administration . SLOW INTRAVENOUS ADMINISTRATION ADULTS: Morphine sulfate may be administered intravenously when a rapid onset of action is desired. The dose is usually in the range of 2.5 to 15 mg given slowly over 4 to 5 minutes. CHILDREN: When a rapid onset of action is desirable, in a closely monitored environment, morphine may be titrated intravenously with caution, in a dose of 0.05 to 0.1 mg/kg, incrementally over 5 to 15 minutes. Repeat intravenous dosing is unsubstantiated as a method of analgesia in children. Morphine sulfate is not usually given pre-operatively in children under 1 year, and it should be given with extreme care to neonates. It should not be given to premature infants (see Section 4.3). CONTINUOUS INTRAVENOUS INFUSION The dosage of morphine should be titrated according to the patient’s analgesic requirements and previous opiate experience. For the management of acute pain via intravenous infusion, most adults with no previous history of opioid intake can be continued on 0.5 to 2.0 mg/hour after adequate analgesia has been established. In children, an infusion dose 전체 문서 읽기