Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 50 mg
Hameln Pharma Pty Ltd
Injection, solution
Excipient Ingredients: citric acid monohydrate; hydrochloric acid; sodium citrate dihydrate; water for injections; sodium hydroxide; sodium chloride
Subcutaneous, Intravenous Infusion
5 ampoules, 10 ampoules
(S8) Controlled Drug
Oxycodone-hameln solution for injection or infusion 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: A clear colourless solution for injection free of visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-10-07
OXYCODONE-HAMELN v1.0 020721 1 OXYOCODONE-HAMELN INJECTION 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-HAMELN? Oxycodone-hameln contains the active ingredient oxycodone hydrochloride. Oxycodone-hameln 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-hameln ? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN OXYCODONE-HAMELN? 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-HAMELN WORKS AND MAY RESULT IN SIDE- EFFECTS. PRIOR TO BEING TREATED WITH OXYCODONE-HAMELN, 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-hameln ? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Oxycodone-hameln 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 WILL I BE GIVEN OXYCODONE-HAMELN? • Your doctor will decide the appropriate dose for you. • Follow the instructions given to you by your doctor or pharmacist exactly. • Oxycodone-hameln 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 -hameln? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING OXYCODONE-HAMELN? THINGS YOU SHOULD DO • Remind an Aqra d-dokument sħiħ
AUSTRALIAN PRODUCT INFORMATION – OXYCODONE-HAMELN (OXYCODONE HYDROCHLORIDE) SOLUTION FOR INJECTION OR INFUSION WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Oxycodone-hameln solution for injection or infusion 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-hameln solution for injection or infusion 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-hameln solution for injection or infusion. 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 Oxycodone-hameln solution for injection or infusion. 1 NAME OF THE MEDICINE Oxycodone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Oxycodone-hameln 10 mg in 1 mL; 20 mg i Aqra d-dokument sħiħ