Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
fentanyl, Quantity: 12.375 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: Rectangular, round cornered, transparent and colourless patch with 22.5 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
Licence status A
2012-08-28
DUTRAN CMI 050315 Page 1 of 5 DUTRAN TRANSDERMAL DRUG DELIVERY SYSTEM _ contains the active ingredient fentanyl _ _ _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DUTRAN. 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 DUTRAN against the benefits this medicine is expected to have for you. If you have any concerns about using DUTRAN, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT DUTRAN IS USED FOR DUTRAN is used to relieve chronic or long-lasting pain, which requires strong painkillers. DUTRAN contains a medicine called 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 onto the skin every 72 hours (3 days). The patch releases a continuous amount of fentanyl that is absorbed through the skin in contact with the patch. Your doctor may have prescribed DUTRAN for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. _Warning _ _ _ DUTRAN PATCHES MAY BE RETRIEVED AND ABUSED BY ADDICTS. PLEASE ENSURE THAT USED PATCHES ARE CONCEALED AND DISPOSED OF CAREFULLY. RETURN UNUSED PATCHES TO THE PHARMACY (SEE DISPOSAL AT THE END OF THIS LEAFLET). KEEP USED AND UNUSED PATCHES WHERE CHILDREN CANNOT REACH THEM. BEFORE YOU USE DUTRAN _When you must not use it _ _ _ Do not use DUTRAN • if you have an allergy to fentanyl or any of the ingredients. See Product Description at the end of this leaflet for a list of ingredients. • for acute pain or pain following surgery • for mild or intermittent pain • at a starting dose greater than 25 micrograms/hour if you have never had opioid analgesics for pain relief. Do not use DUTRAN if the packaging is Perskaitykite visą dokumentą
AUSTRALIAN PRODUCT INFORMATION - DUTRAN TM (FENTANYL) TRANSDERMAL DRUG DELIVERY SYSTEM WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, Dutran 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 _ Dutran 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 Dutran. 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 Dutran. 1. NAME OF THE MEDICINE Fentanyl 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dutran is available in five different strengths delivering fentanyl 12, 25, 50, 75 or 100 microgram/hour to the systemic circulation. DUTRAN 12 – Each transdermal patch with 3.75 cm 2 active surface area contains 2.063 mg fentanyl with a rele Perskaitykite visą dokumentą