国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
fentanyl, Quantity: 16.8 mg
Sandoz Pty Ltd
Fentanyl
Drug delivery system, transdermal
Excipient Ingredients: polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; 2,2'-azobisisobutyronitrile; 2-hydroxyethyl acrylate
Transdermal
3, 7, 4, 8, 10, 1, 2, 5
(S8) Controlled Drug
For the management of pain associated with cancer, palliative cancer 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-naive patients.
Visual Identification: Dull, homogenous, rectangular transdermal drug delivery system on release liner, imprint on backing foil 'fentanyl 100 microgram/h'; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2009-12-22
Fentanyl Sandoz ® 1 FENTANYL SANDOZ ® _fentanyl transdermal patches _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fentanyl Sandoz. 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 this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FENTANYL SANDOZ IS USED FOR Fentanyl Sandoz is used for the long- term management of pain that is severe enough to require daily around-the-clock pain relievers, when other treatment options are not able to effectively manage your pain or you cannot tolerate them. Fentanyl Sandoz is only used in people who have previously been using other opioid-based pain relief. Fentanyl Sandoz is not used to treat pain that you only have once in a while. It contains the active ingredient fentanyl. Fentanyl belongs to a group of medicines called opioid analgesics. It works by blocking the nerves that recognise pain messages from the body. Each patch is applied onto the skin every three days (72 hours). The patch releases a continuous amount of fentanyl that is absorbed through the skin in contact with the patch. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine may be addictive. This medicine is available only with a doctor's prescription. BEFORE YOU USE FENTANYL SANDOZ _WARNING _ Opioids can be abused and misused, and you are at risk for opioid addiction, even if you take your dose WARNING LIMITATIONS OF USE Fentanyl Sandoz 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 Fen 完全なドキュメントを読む
200910-Fentanyl Sandoz-pi Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION FENTANYL SANDOZ ® (FENTANYL) TRANSDERMAL DRUG DELIVERY SYSTEM 1 NAME OF THE MEDICINE Fentanyl 2 QUALITATIVE AND QUANTITATIVE COMPOSITION It is available in six different strengths delivering fentanyl 12, 25, 37, 50, 75 or 100 micrograms/hour to the systemic circulation. The amount of fentanyl released from each patch per hour is proportional to the surface area. The composition per unit area of all patches is identical. Fentanyl Sandoz 12 µg/h transdermal patch – surface area of 5.25 cm 2 Fentanyl Sandoz 25 µg/h transdermal patch – surface area of 10.5 cm 2 Fentanyl Sandoz 37 µg/h transdermal patch* – surface area of 15.75 cm 2 Fentanyl Sandoz 50 µg/h transdermal patch – surface area of 21 cm 2 Fentanyl Sandoz 75 µg/h transdermal patch – surface area of 31.5 cm 2 WARNINGS _LIMITATION OF USE _ Because of the risks associated with the use of opioids, Fentanyl Sandoz should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise adequate to provide appropriate management of pain (see Section 4.4 Special warnings and precautions for use). _HAZARDOUS AND HARMFUL USE _ Fentanyl Sandoz 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 Fentanyl Sandoz. 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 u 完全なドキュメントを読む