País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
morphine hydrochloride trihydrate, Quantity: 10 mg/mL
Juno Pharmaceuticals Pty Ltd
morphine hydrochloride trihydrate
Injection, solution
Excipient Ingredients: water for injections; dilute hydrochloric acid
Subcutaneous, Intramuscular, Intravenous Infusion
5 and 10
(S8) Controlled Drug
- 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. - Symptomatic relief of severe and intractable pains in terminal cancer patients. - Use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.
Visual Identification: Clear colourless to pale yellow solution in a yellow ampoule; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-05-06
Page 1 MORPHINE JUNO Morphine hydrochloride trihydrate injection _(MOR-feen)_ _ _ _ _ CONSUMER MEDICINE INFORMATION _Date of Dispensing _ _Consumer Name _ _Pharmacist Name_ _Consumer Address _ _Pharmacist Address_ _ _ _ _ WARNING LIMITATIONS OF USE Morphine 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 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 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 hydrochloride 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 hydrochloride 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. Page 2 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Morphine Juno morphine hydrochloride trihydrate injection (Morphine). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits . Your doctor has weighed the risks of you being given Morphine Juno against the benefits they exp Llegiu el document complet
Australian Product Information Page | 1 AUSTRALIAN PRODUCT INFORMATION MORPHINE JUNO (MORPHINE HYDROCHLORIDE TRIHYDRATE)_ _ _ _ 1 NAME OF THE MEDICINE Morphine hydrochloride trihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Morphine Juno is a sterile solution containing morphine hydrochloride 10 milligrams/mL and 20 milligrams/mL in water for injections. The solution does not contain any antioxidant or preservative. The pH of the solution ranges between 3.0 and 5.0, 0.1N hydrochloric acid is used to adjust the pH of the solution WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, morphine 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 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. 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, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics, general anaesthetics, tranquilisers, beta blocker, or other central nervous system (CNS) depressants, including alcohol, may result in Llegiu el document complet