Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
morphine sulfate pentahydrate, Quantity: 30 mg
Medsurge Pharma Pty Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium chloride; water for injections
Intramuscular, Intravenous, Subcutaneous
5 x 30 mg/1 mL ampoules, 50 x 30 mg/1 mL ampoules
(S8) Controlled Drug
For the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. May also be used as a pre-operative medication and as an analgesic adjunct in general anaesthesia.
Visual Identification: Clear colourless to slightly yellow solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-07-09
CMI EDITION 3.0 DECEMBER 2020 1 MORPHINE SULFATE _MORPHINE SULFATE PENTAHYDRATE _ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE Morphine Sulfate injection should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them. HAZARDOUS AND HARMFUL USE Morphine Sulfate injection poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. LIFE THREATENING RESPIRATORY DEPRESSION Morphine Sulfate injection can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting morphine sulfate and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. USE OF OTHER MEDICINES WHILE USING MORPHINE Using morphine sulfate with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using morphine. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Morphine Sulfate injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP-TO-DATE INFORMATION ON THE MEDICINE. Those updates may Läs hela dokumentet
MORPHINE SULFATE INJECTION _ _ PRODUCT INFORMATION Edition 4.0 May 2022 Page 1 of 23 AUSTRALIAN PRODUCT INFORMATION MORPHINE SULFATE MEDSURGE (MORPHINE SULFATE PENTAHYDRATE) SOLUTION FOR INJECTION WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Morphine Sulfate injection should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). HAZARDOUS AND HARMFUL USE Morphine Sulfate injection poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient’s risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). LIFE THREATENING RESPIRATORY DEPRESSION Serious, life-threatening or fatal respiratory depression may occur with the use of Morphine Sulfate injection. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL Concomitant use of opioids with other opioids analgesics, benzodiazepines, gabapentinoids, sedatives, hypnotics, antipsychotics, antihistamines, tricyclic antidepressants, centrally-active anti-emetics, general anaesthetics, tranquilisers, beta blocker, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Morphine Sulfate injection (see section 4.4 SPECIAL WARNINGS Läs hela dokumentet