Country: Малта
Језик: Енглески
Извор: Medicines Authority
DIAMORPHINE HYDROCHLORIDE
Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland
N07BC06
DIAMORPHINE HYDROCHLORIDE 5 mg
POWDER FOR INJECTION
DIAMORPHINE HYDROCHLORIDE 5 mg
POM
OTHER NERVOUS SYSTEM DRUGS
Withdrawn
2019-03-26
Page 1 of 14 PACKAGE LEAFLET: INFORMATION FOR THE USER DIAMORPHINE HYDROCHLORIDE 5MG, 10MG, 30MG, 100MG, 250MG AND 500MG FOR INJECTION THIS MEDICINE CONTAINS DIAMORPHINE HYDROCHLORIDE WHICH IS AN OPIOID, WHICH CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT SUDDENLY. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, nurse or pharmacist. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Diamorphine Injection is and what it is used for 2. What you need to know before you are given Diamorphine Injection 3. How Diamorphine Injection should be given 4. Possible side effects 5. How to store Diamorphine Injection 6. Contents of the pack and other information 1. WHAT DIAMORPHINE INJECTION IS AND WHAT IT IS USED FOR This medicine had been prescribed for you to relieve moderate to severe pain. Diamorphine is used for the relief of severe pain associated with surgical procedures, heart attack and pain in terminally ill patients. It is also used to treat breathlessness caused by fluid in the lungs. It contains diamorphine hydrochloride which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DIAMORPHINE INJECTION DIAMORPHINE INJECTION SHOULD NOT BE GIVEN IF YOU: • have ever had a reaction to or been told that you are allergic to diamorphine or morphine • have been told you have a tumour of the adrenal gland Прочитајте комплетан документ
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diamorphine Hydrochloride 5mg for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DIAMORPHINE HYDROCHLORIDE 5MG FOR INJECTION - Each ampoule contains 5mg of Diamorphine Hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A white to off-white, sterile, freeze-dried powder of Diamorphine Hydrochloride for reconstitution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diamorphine may be used in the treatment of severe pain associated with surgical procedures, myocardial infarction or pain in the terminally ill and for the relief of dyspnoea in acute pulmonary oedema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Diamorphine may be given by the intramuscular, intravenous or subcutaneous routes. Glucose intravenous infusion is the preferred diluent, particularly when the drug is administered by a continuous infusion pump over 24 to 48 hours, although it is also compatible with sodium chloride intravenous infusion. The dose should be suited to the individual patient. Posology ADULTS: ACUTE PAIN: 5mg repeated every four hours if necessary (up to 10mg for heavier, well muscled patients) by subcutaneous or intramuscular injection. By slow intravenous injection, one quarter to one half the corresponding intramuscular dose. CHRONIC PAIN: 5-10mg regularly every four hours by subcutaneous or intramuscular injection. The dose may be increased according to individual needs. MYOCARDIAL INFARCTION: 5mg by slow intravenous injection (1mg/minute) followed by a further 2.5mg to 5mg if necessary. ACUTE PULMONARY OEDEMA: 2.5mg to 5mg by slow intravenous injection (1mg/minute). CHILDREN AND ELDERLY: As diamorphine has a respiratory depressant effect, care should be taken when giving the drug to the very young and the elderly and a lower starting dose than normal is recommended. HEPATIC IMPAIRMENT: A reduction in dosage should be considered in hepatic impairment. RENAL IMPAIRMENT: Th Прочитајте комплетан документ