Country: Սինգապուր
language: անգլերեն
source: HSA (Health Sciences Authority)
MORPHINE 7.52 mg/mL EQV MORPHINE SULPHATE PENTAHYDRATE
ZYFAS PHARMA PTE LTD
N02AA01
10mg
INJECTION, SOLUTION
MORPHINE 7.52 mg/mL EQV MORPHINE SULPHATE PENTAHYDRATE 10mg
INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR
Prescription Only
Siegfried Hameln GmbH
ACTIVE
2009-02-09
MORPHINE-HAMELN 10 MG/ML INJECTION SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Morphine-hameln 10 mg/ml Injection Active substance: Morphine sulfate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: Morphine sulfate 5 H 2 O 10.00 mg, equivalent to morphine 7.52 mg 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Morphine sulfate is indicated for the relief of moderate to severe pain not re- sponsive to non-opioid analgesics. It may also be used as a pre-operative med- ication and as an analgesic adjunct in general anaesthesia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Subcutaneous, intramuscular and slow intravenous administration _Adults_ Morphine sulfate is usually administered by intramuscular or subcutaneous injection, in the range of 5 to 20 mg, depending on the cause of pain and the patient response. Doses may be repeated every 4 to 6 hours. Morphine sulfate may also be given intravenously when a rapid onset of action is desired. The dose is usually in the range of 2.5 to 15 mg diluted in 4 to 5 ml of water for injections given slowly over 4 to 5 minutes. _Children_ Morphine sulfate is given by intramuscular or subcutaneous injection in doses of 0.1 to 0.2 mg/kg bodyweight to a maximum of 15 mg. Injection may be repeated every 4 to 6 hours. 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 unsub- stantiated 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_ Contraindications)_. 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 acut read_full_document