Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
fentanyl citrate, Quantity: 628 microgram (Equivalent: fentanyl, Qty 400 microgram)
Teva Pharma Australia Pty Ltd
Fentanyl citrate
Tablet, orally disintegrating
Excipient Ingredients: magnesium stearate; sodium carbonate; sodium starch glycollate type A; sodium bicarbonate; citric acid; mannitol
Buccal
28, 4
(S8) Controlled Drug
Fentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
Visual Identification: White to off-white, flat-faced, round, bevelled tablet, debossed with "C" on one side and with "4" on the other side; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-03-06
FENTORA ® _ORALLY DISINTEGRATING TABLETS_ _Fentanyl (as citrate)_ CONSUMER MEDICINE INFORMATION (CMI) WARNING LIMITATIONS OF USE Fentora 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 Fentora poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor may you regularly during treatment. LIFE THREATENING RESPIRATORY DEPRESSION Fentora 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 Fentora 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 FENTORA Using Fentora 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 Fentora. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fentora. It does not contain all of 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 your taking Fentora against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING FENTORA, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT FENTORA IS USED FOR Fentora contains a medicine called fentanyl citrate. It is a pain- Læs hele dokumentet
Based on CCSI 439/19/05/21 Version 5.0 1 AUSTRALIAN PRODUCT INFORMATION – FENTORA (FENTANYL CITRATE) ORALLY DISINTEGRATING TABLETS WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, FENTORA 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 _ FENTORA 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 FENTORA. 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 FENTORA. Based on CCSI 439/19/05/21 Version 5.0 2 1 NAME OF THE MEDICINE Fentanyl citrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FENTORA (fentanyl citrate) is a synthetic opioid analgesic related to pethidine and with similar properties to morphine. Fentanyl citrate is a white, crystalline pow Læs hele dokumentet