देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
morphine hydrochloride trihydrate, Quantity: 2 mg/mL
Arrotex Pharmaceuticals Pty Ltd
morphine hydrochloride trihydrate
Oral Liquid, solution
Excipient Ingredients: sodium methyl hydroxybenzoate; glycerol; sodium citrate dihydrate; water for injections; disodium edetate; citric acid
Oral
1 x 200mL
(S8) Controlled Drug
ORDINE oral solution is indicated 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.
Visual Identification: Clear, colourless to pale yellow aqueous solution; Container Type: Bottle; Container Material: Polyethylene Terephthalate; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2008-08-26
ORDINE® oral solution 1 ORDINE ® oral solution Consumer Medicine Information (CMI) summary The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. Why am I using ORDINE? ORDINE contains the active ingredient morphine hydrochloride trihydrate. ORDINE is used for the short-term relief of severe pain for which other treatment options have failed, or otherwise unsuitable to provide sufficient management of pain. For more information, see Section 1. Why am I using ORDINE? in the full CMI. 2. What should I know before I use ORDINE? Do not use if you have ever had an allergic reaction to morphine or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use ORDINE? in the full CMI. 3. What if I am taking other medicines? Some medicines may interfere with ORDINE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. How do I use ORDINE? Your doctor will tell you exactly how much to take. Measure the dose accurately with a medicine measure. Follow the instructions given to you by your doctor or your pharmacist. You must only take ORDINE by mouth. More instructions can be found in Section 4. How do I use ORDINE? in the full CMI. 5. What should I know while using ORDINE? Things you should do Remind any doctor or dentist you visit that you are using ORDINE. Tell your doctor or pharmacist if you are taking any other medicines that you use to help you relax, anything that contains alcohol (like cough syrup) or other medicines that treat pain. Things you should not do Do not stop using this medicine suddenly. Do not take पूरा दस्तावेज़ पढ़ें
ORDINE ® ORAL SOLUTION Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION – ORDINE ® (MORPHINE HYDROCHLORIDE TRIHYDRATE) ORAL SOLUTION WARNINGS Limitations of use Because of the risks associated with the use of opioids, ORDINE oral solution 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 ORDINE oral solution 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 ORDINE oral solution. 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 benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, 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 ORDINE oral solution. 1 NAME OF THE MEDICINE Morphine hydrochloride trihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ORDINE oral solution (1 mg/mL) contains morphine hydrochloride trihydrate 1 mg/mL. * ORDINE oral solution (2 mg/mL) contains morphine hydrochloride tr पूरा दस्तावेज़ पढ़ें