国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 50 mg
Juno Pharmaceuticals Pty Ltd
oxycodone hydrochloride
Injection, solution
Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; sodium chloride; hydrochloric acid; sodium hydroxide; water for injections
Intravenous, Subcutaneous
5 ampoules
(S8) Controlled Drug
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 and colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2017-08-31
OXYCODONE JUNO SOLUTION FOR INJECTION OR INFUSION 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 BEING GIVEN OXYCODONE JUNO? Oxycodone J uno contains the active ingredient oxycodone hydrochloride. Oxycodone Juno 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 being given Oxycodone J uno? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN OXYCODONE JUNO? Do not use if you have ever had an allergic reaction to oxycodone or any of the ingredients listed at the end of the CMI. A NUMBER OF MEDICAL CONDITIONS AND OTHER DRUGS CAN AFFECT THE WAY OXYCODONE JUNO WORKS AND MAY RESULT IN SIDE-EFFECTS. PRIOR TO BEING TREATED WITH OXYCODONE JUNO, 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 am given Oxycodone-J uno? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Oxycodone J uno and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? i n the full CMI. 4. HOW WILL I BE GIVEN OXYCODONE JUNO? • Your doctor will decide the appropriate dose for you. • Follow the instructions given to you by your doctor or pharmacist exactly. • Oxycodone Juno must only be administered by injection, and will normally be given to you by a doctor or nurse. More instructions can be found in Section 4. How will I be given Oxycodone J uno? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING OXYCODONE JUNO? THINGS YOU SHOULD DO • • Remind any doctor, dentist or pharmacist 阅读完整的文件
Juno Pharmaceuticals Pty Ltd Australian Product Information Page | 1 AUSTRALIAN PRODUCT INFORMATION OXYCODONE JUNO _(OXYCODONE HYDROCHLORIDE) _ _ _ WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, Oxycodone Juno 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 Oxycodone Juno 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 Oxycodone Juno. 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 receiving Oxycodone Juno. 1 NAME OF THE MEDICINE Oxycodone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxycodone Juno 10 mg / 1 mL solution for injection ampoule contains 10 mg of oxycodone hydrochloride. Oxycodone Juno 20 mg / 2 mL solution for injection ampoule cont 阅读完整的文件