Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
fentanyl, Quantity: 1.28 mg
Alphapharm Pty Ltd
Fentanyl
Drug delivery system, transdermal
Excipient Ingredients: dimeticone 360; titanium dioxide; potable water; trolamine; strong ammonia solution; industrial methylated spirit; styrene/acrylates copolymer; polyethylene; polytef; dimeticone 350; docusate sodium; propylene glycol; purified water; acrylates copolymer; methoxyisopropyl acetate; 2-ethylhexyl acrylate; polyethylene terephthalate; polyvinylidene flouride; methylated trimethylated silica; heptane; ethyl acetate; Polyisocyanate; 4,4'-diphenylmethane diisocyanate; Silane; polypropylene; ethylene/propylene copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; tris(2,4-ditert-butyphenyl) phosphite; calcium stearate; aluminium magnesium hydroxide carbonate; perflouropropylene/vinylidene diflouride copolymer; 1,3,5-trimethyl-2,4,6-tris(3,5-ditert-butyl-4-hydroxybenzyl)benzene; aluminium calcium sodium silicate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; iron oxide red; pigment yellow 119; zinc stearate
Transdermal
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: Translucent, rectangular patch with rounded corners, randomly printed with white ink "Fentanyl 1.28mg delivers 12ug/hr", on a removable release liner; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2010-12-07
DENPAX _TRANSDERMAL SYSTEM_ _fentanyl_ CONSUMER MEDICINE INFORMATION WARNING LIMITATIONS OF USE DENPAX 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 DENPAX 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 DENPAX 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 DENPAX 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 DENPAX 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 DENPAX. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DENPAX. 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 DENPAX against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT DENPAX IS USED FOR DENPAX is used to relieve chronic Izlasiet visu dokumentu
AUSTRALIAN PRODUCT INFORMATION DENPAX _fentanyl transdermal patch _ WARNINGS LIMITATIONS OF USE Because of the risks associated with the use of opioids, DENPAX 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 DENPAX 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 DENPAX. 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 DENPAX. 1 NAME OF THE MEDICINE Fentanyl 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in DENPAX is fentanyl. DENPAX transdermal drug delivery systems are available in five different strengths. a The lowest dose is designated as 12 micrograms/hour (however, the actual dosage is 12.5 micrograms/hour) to distinguish it from a 125 micrograms/hour dosage that co Izlasiet visu dokumentu