国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
fentanyl, Quantity: 8.25 mg
Medis Pharma Pty Ltd
Fentanyl
Drug delivery system, transdermal
Excipient Ingredients: titanium dioxide; polypropylene; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane
Transdermal
5 patches
(S8) Controlled Drug
For the management of pain associated with cancer, palliative care, and other conditions in patients where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? severe enough to require daily, continuous, long term opioid treatment. Not for use in opioid-na?ve patients.
Visual Identification: Fenpatch 50 is a rectangular, round cornered, transparent and colourless patch with 15 cm2 active surface area contained in a protective pouch made from composite foil.; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2009-07-07
________________________________________________________________________________ Fenpatch CMI 110520 Page 1 of 6 FENPATCH® TRANSDERMAL DRUG DELIVERY SYSTEM _ _ _contains the active ingredient fentanyl _ CONSUMER MEDICINE INFORMATION _ _ WARNING LIMITATIONS OF USE FENPATCH 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 FENPATCH 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 FENPATCH can cause life-threatening or fatal breathing difficulties (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 FENPATCH 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. CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL Using FENPATCH 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 FENPATCH. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FENPATCH. 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 using FENPATCH against the benefits this medicine is expected to have for you. If you have any concer 阅读完整的文件
Page 1 of 29 AUSTRALIAN PRODUCT INFORMATION - FENPATCH ® (FENTANYL) TRANSDERMAL DRUG DELIVERY SYSTEM WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Fenpatch 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 _ Fenpatch 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 Fenpatch. 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 Fenpatch. 1. NAME OF THE MEDICINE Fentanyl 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fenpatch is available in five different strengths delivering 12, 25, 50, 75 or 100 microgram/hour of fentanyl to the systemic circulation. FENPATCH 12 – Each transdermal patch with 3.75 cm 2 active surface area contains 阅读完整的文件