MORPHINE SULPHATE 20 Mg/Ml Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
MORPHINE SULPHATE
Available from:
Auden Mckenzie (Pharma Division) Ltd
INN (International Name):
MORPHINE SULPHATE
Dosage:
20 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Morphine Sulphate 20mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Morphine Sulphate solution for injection contains 20 mg morphine sulphate.
Also contains 1.1 mg of sodium metabisulphite (E223) and 0.24mg of sodium in each ml of Morphine Sulphate
solution for injection.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Morphine is used for the symptomatic relief of severe pain; relief of dyspnoea of left ventricular failure and pulmonary
oedema; pre-operative use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The injection may be given by the intravenous, intramuscular or subcutaneous route.
Adults: The dosage should be based on the severity of the pain and the response and tolerance of the patient. The usual
adult subcutaneous or intramuscular dose is 10mg every 4 hours if necessary, but may range from 5mg to 20mg.
The usual adult intravenous dose is 2.5mg to 15mg not more than 4 hourly, where necessary, but dosage and dosing
interval must be titrated against the patient's response and adjustments made until analgesia is achieved.
Elderly: Because of the depressant effect on respiration, caution is necessary when giving morphine to the elderly and
reduced doses may be required.
Children: Use in children is not recommended.
4.3 CONTRAINDICATIONS
Respiratory depression, obstructive airways disease, concurrent treatment with monoamine oxidase inhibitors or within
two weeks of their discontinuation of treatment with them.
Known morphine sensitivity, or sensitivity to any of the ingredients. Cerebral oedema, head injuries, coma, convulsive
disorders and raised
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