Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - fentanyl, quantity: 12.6 mg - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; 2,2'-azobisisobutyronitrile; 2-hydroxyethyl acrylate - 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.

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl transdermal system is indicated for management of persistent , moderate to severe chronic pain that: - requires continuous, around-the-clock opioid administration for an extended period of time, and - cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. fentanyl transdermal system should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr (see dosage and administration ). patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid. because serious or life-threatening hypoventilation could result, fentanyl transdermal system is contraindicated for use on an as needed basis (i.e., p

United States - English - NLM (National Library of Medicine)

quality care products, llc - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60　mg morphine per day, 25 mcg transdermal fentanyl per hour, 30　mg oral oxycodone per day, 8　mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see warnings and precautions ( 5.1)] , reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not to

United States - English - NLM (National Library of Medicine)

quality care products, llc - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60　mg morphine per day, 25 mcg transdermal fentanyl per hour, 30　mg oral oxycodone per day, 8　mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see warnings and precautions (5.1)] , reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - fentanyl 10.2mg (alkaloid powder) - transdermal patch - 100 mcg/h - active: fentanyl 10.2mg (alkaloid powder) excipient: dimeticone polyolefin film (mediflex 1000) 25 square centimeters polyester release liner (scotchpak 1022) 37.34 square centimeters no-tox white fgn-4194 nt23 silicone adhesive - mylan fentanyl patch is indicated in the management of chronic cancer pain. mylan fentanyl patch is also indicated in the management of opioid-responsive chronic severe pain of non-malignant origin in opioid tolerant patients, after other conservative methods of analgesia have been tried. it is indicated for use in accordance with nzma guidelines on chronic pain management and where there is no psychological contraindication, drug seeking behaviour or history of drug misuse.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - fentanyl 1.28mg (alkaloid powder) - transdermal patch - 12 mcg/h - active: fentanyl 1.28mg (alkaloid powder) excipient: dimeticone polyolefin film (mediflex 1000) 3.13 square centimeters polyester release liner (scotchpak 1022) 10.16 square centimetres no-tox white fgn-4194 nt23 silicone adhesive - mylan fentanyl patch is indicated in the management of chronic cancer pain. mylan fentanyl patch is also indicated in the management of opioid-responsive chronic severe pain of non-malignant origin in opioid tolerant patients, after other conservative methods of analgesia have been tried. it is indicated for use in accordance with nzma guidelines on chronic pain management and where there is no psychological contraindication, drug seeking behaviour or history of drug misuse.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - fentanyl 2.55mg (alkaloid powder) - transdermal patch - 25 mcg/h - active: fentanyl 2.55mg (alkaloid powder) excipient: dimeticone polyolefin film (mediflex 1000) 6.25 square centimeters polyester release liner (scotchpak 1022) 13.21 square centimetres no-tox white fgn-4194 nt23 silicone adhesive - mylan fentanyl patch is indicated in the management of chronic cancer pain. mylan fentanyl patch is also indicated in the management of opioid-responsive chronic severe pain of non-malignant origin in opioid tolerant patients, after other conservative methods of analgesia have been tried. it is indicated for use in accordance with nzma guidelines on chronic pain management and where there is no psychological contraindication, drug seeking behaviour or history of drug misuse.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - fentanyl 5.1mg (alkaloid powder) - transdermal patch - 50 mcg/h - active: fentanyl 5.1mg (alkaloid powder) excipient: dimeticone polyolefin film (mediflex 1000) 12.5 square centimeters polyester release liner (scotchpak 1022) 22.35 square centimeters no-tox white fgn-4194 nt23 silicone adhesive - mylan fentanyl patch is indicated in the management of chronic cancer pain. mylan fentanyl patch is also indicated in the management of opioid-responsive chronic severe pain of non-malignant origin in opioid tolerant patients, after other conservative methods of analgesia have been tried. it is indicated for use in accordance with nzma guidelines on chronic pain management and where there is no psychological contraindication, drug seeking behaviour or history of drug misuse.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - fentanyl 7.65mg (alkaloid powder) - transdermal patch - 75 mcg/h - active: fentanyl 7.65mg (alkaloid powder) excipient: dimeticone polyolefin film (mediflex 1000) 18.75 square centimeters polyester release liner (scotchpak 1022) 28.45 square centimeters no-tox white fgn-4194 nt23 silicone adhesive - mylan fentanyl patch is indicated in the management of chronic cancer pain. mylan fentanyl patch is also indicated in the management of opioid-responsive chronic severe pain of non-malignant origin in opioid tolerant patients, after other conservative methods of analgesia have been tried. it is indicated for use in accordance with nzma guidelines on chronic pain management and where there is no psychological contraindication, drug seeking behaviour or history of drug misuse.

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - fentanyl - transdermal patch - 50 microgram