Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
tramadol hydrochloride, Quantity: 100 mg
Juno Pharmaceuticals Pty Ltd
Tramadol hydrochloride
Injection, solution
Excipient Ingredients: sodium acetate trihydrate; water for injections
Intramuscular, Intravenous
5 ampoules x 2mL
(S4) Prescription Only Medicine
TRAMADOL AN solution for injection 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: Ampoule containing a transparent, colourless or slightly yellowish 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
2014-01-28
Tramadol AN cmi 1 TRAMADOL AN INJECTION _Tramadol hydrochloride_ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE TRAMADOL AN 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 TRAMADOL AN 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 TRAMADOL AN 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 treatment and after a dose increase. Your doctor will monitor you and change the dose as appropriate. USE OF OTHER MEDICINES WHILE USING TRAMADOL AN Using TRAMADOL AN 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 TRAMADOL AN. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TRAMADOL AN. 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 taking TRAMADOL AN against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. WHAT TRAMADOL AN IS USED FOR TRAMADOL AN is used to relieve moderate to severe pain and belongs to a group of medicines called ana Прочитајте комплетан документ
Australian Product Information Tramadol AN PI v8.0 Page | 1 AUSTRALIAN PRODUCT INFORMATION _ _ _TRAMADOL AN_ _ _ _(TRAMADOL HYDROCHLORIDE) _ _ _ WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, TRAMADOL AN 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 TRAMADOL AN 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 TRAMADOL AN. 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 TRAMADOL AN. 1 NAME OF THE MEDICINE Tramadol hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tramadol hydrochloride is an odourless, white to off-white crystalline powder that is freely soluble in both water and methanol and has a pKa of 9.41. The water/n-octanol partition Прочитајте комплетан документ