देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
fentanyl, Quantity: 4.2 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
8, 5, 10, 2, 7, 1, 4, 3
(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 25 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
APO-Fentanyl 1 APO-FENTANYL _fentanyl transdermal patches _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APO-Fentanyl patches. 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 APO-Fentanyl against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING APO-FENTANYL, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT APO- FENTANYL IS USED FOR APO-Fentanyl 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. APO-Fentanyl is only used in people who have previously been using other opioid-based pain relief. APO- Fentanyl is not used to treat pain that you only have once in a while. APO-Fentanyl patches contains a medicine call fentanyl. This strong pain reliever belongs to a group of medicines known as opioid analgesics. Fentanyl relieves pain by blocking the nerves that recognise pain messages from the body. Each patch is applied on 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. Your doctor may have prescribed APO-Fentanyl for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU USE APO-FENTANYL _WARNING _ Opioids can be abused and misused, and you are at risk for opioid addiction, even if you take your dose as prescribed. Opioid addiction, abuse and misuse can lead to overdose and death. 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. HA पूरा दस्तावेज़ पढ़ें
200910-APO-Fentanyl-pi Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION APO-FENTANYL (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. APO-Fentanyl 12 µg/h transdermal patch – surface area of 5.25 cm 2 APO-Fentanyl 25 µg/h transdermal patch – surface area of 10.5 cm 2 APO-Fentanyl 37 µg/h transdermal patch* – surface area of 15.75 cm 2 APO-Fentanyl 50 µg/h transdermal patch – surface area of 21 cm 2 APO-Fentanyl 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, APO-Fentanyl 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 _ APO-Fentanyl 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 APO- Fentanyl. 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 पूरा दस्तावेज़ पढ़ें