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

b braun australia pty ltd - fentanyl citrate, quantity: 785 microgram (equivalent: fentanyl, qty 500 microgram) - injection, solution - excipient ingredients: sodium chloride; water for injections - analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises - use as an opioid analgesic supplement in general and regional anaesthesia - administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

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

b braun australia pty ltd - fentanyl citrate, quantity: 157 microgram (equivalent: fentanyl, qty 100 microgram) - injection, solution - excipient ingredients: sodium chloride; water for injections - analgesic action of short duration during anaesthetic periods, premedication, induction and maintenance, and in the immediate post-operative period (recovery room) as the need arises - use as an opioid analgesic supplement in general and regional anaesthesia - administration with a neuroleptic such as droperidol injection as an anaesthetic premedication, for the induction of anaesthesia, and as an adjunct in the maintenance of general and regional anaesthesia.

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

bryant ranch prepack - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl transdermal system is contraindicated in the following patients and situations: clinical considerations fetal/neonatal adverse reactions prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see warnings precautions (5.4)]. teratogenic effects pregnancy c: there are no adequate and well-controlled studies in pregnant women. fentanyl transdermal system should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the potential effects of fentanyl on embryo-fetal development were studied in the rat, mouse, and rabbit models. published literature reports that administration of fentanyl (0, 10, 100, or 500 mcg/kg/day) to pregnant female sprague-dawley

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

rebel distributors corp - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 25 ug in 1 h - 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.

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

rebel distributors corp. - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 50 ug in 1 h - 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.

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

akorn - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 50 ug in 1 ml - fentanyl citrate injection is indicated for: - analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. - use as a narcotic analgesic supplement in general or regional anesthesia. - administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. - use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. fentanyl citrate injection is contraindicated in patients with: - hypersensitivity to fentanyl (e.g., anaphylaxis) [see adverse reactions (6.2)] risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with fentanyl citrate injection in pregnant women are insufficient to inform a drug-associa

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

fresenius kabi usa, llc - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl citrate injection is indicated for: - analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. - use as a narcotic analgesic supplement in general or regional anesthesia. - administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. - use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. fentanyl citrate injection is contraindicated in patients with: - hypersensitivity to fentanyl (e.g., anaphylaxis) [see adverse reactions (6)] risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with fentanyl citrate injection in pregnant women are insufficient to inform a drug-associate

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

sentynl therapeutics, inc. - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 100 ug - abstral® is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving, and who are tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain. patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine per day, or at least 25 mcg per hour of transdermal fentanyl, or at least 30 mg of oral oxycodone per day, or at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day or an equianalgesic dose of another opioid medication daily for a week or longer. patients must remain on around-the- clock opioids when taking abstral® . limitations of use : - not for use in opioid non-tolerant patients. - not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency department [see contraindications (4)]. - as a part of the tirf

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