Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 50 mg/mL
Mundipharma Pty Ltd
oxycodone hydrochloride
Injection, solution
Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections; sodium hydroxide; sodium chloride; hydrochloric acid
Intravenous, Subcutaneous
1 mL x 5 ampoules
(S8) Controlled Drug
OxyNorm solution for 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 to pale yellow solution, practically free from particulates; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2010-05-12
OXYNORM ® SOLUTION FOR INJECTION OR INFUSION _Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_ CONSUMER MEDICINE INFORMATION WARNING: LIMITATIONS OF USE OxyNorm 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 OxyNorm 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 OxyNorm 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 OxyNorm 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 OXYNORM Using OxyNorm 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 mini- mise 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 OxyNorm. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OxyNorm solution for injection or infusion ("injection or infusion"). 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 this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You Perskaitykite visą dokumentą
OxyNorm ® solution for injection or infusion Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION – OXYNORM ® (OXYCODONE HYDROCHLORIDE) SOLUTION FOR INJECTION OR INFUSION WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, OxyNorm 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 _ OxyNorm 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 OxyNorm 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 OxyNorm solution for injection or infusion. 1 NAME OF THE MEDICINE Oxycodone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSI Perskaitykite visą dokumentą