País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 10 mg/mL
Medsurge Pharma Pty Ltd
Injection, solution
Excipient Ingredients: sodium citrate dihydrate; hydrochloric acid; citric acid monohydrate; sodium chloride; sodium hydroxide; water for injections
Subcutaneous, Intravenous
5 X 10 mg/1 mL, 10 x 10 mg/1 mL
(S8) Controlled Drug
Oxycodone HCL Medsurge 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: Clear colourless or yellowish solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2020-07-23
OXYCODONE HCL OXYCODONE HYDROCHLORIDE CMI Edition 2.0 October 2020 1 | P a g e _CONSUMER MEDICINE INFORMATION _ WARNING LIMITATIONS OF USE Oxycodone hydrochloride solution for injection or infusion 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 Oxycodone hydrochloride solution for injection or infusion 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 Oxycodone hydrochloride solution for injection or infusion 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 Oxycodone hydrochloride solution for injection or infusion 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 Oxycodone hydrochloride solution for injection or infusion Using Oxycodone hydrochloride solution for injection or infusion 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 Oxycodone hydrochloride solution for injection or infusion. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Oxycodone hydrochloride solution for injection or infusion ("injection or infusion"). It does not contain all the available information. It does not t Leia o documento completo
OXYCODONE HYDROCHLORIDE _ _ PRODUCT INFORMATION Edition 3.0 January 2022 Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION OXYCODONE HCL 10 MG/1 ML MEDSURGE OXYCODONE HCL 20 MG/2 ML MEDSURGE OXYCODONE HCL 50 MG/1 ML MEDSURGE (OXYCODONE HYDROCHLORIDE) SOLUTION FOR INJECTION OR INFUSION WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Oxycodone hydrochloride 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 hydrochloride 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 hydrochloride 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 on Oxycodone hydrochloride injection or infu Leia o documento completo