Australië - Engels - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - fentanyl, quantity: 12.375 mg - drug delivery system, transdermal - excipient ingredients: polypropylene; polyethylene terephthalate; titanium dioxide; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - 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.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - fentanyl, quantity: 8.25 mg - drug delivery system, transdermal - excipient ingredients: titanium dioxide; polypropylene; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - 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.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - fentanyl, quantity: 4.125 mg - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; titanium dioxide; polypropylene; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - 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.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - fentanyl, quantity: 2.063 mg - drug delivery system, transdermal - excipient ingredients: polypropylene; polyethylene terephthalate; titanium dioxide; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - 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.

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - fentanyl - transdermal patch - 25microgram/1hour

Verenigde Staten - Engels - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 12 ug in 1 h - fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid tolerant patients, that requires an extended treatment period with a daily opioid analgesic 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: fentanyl transdermal system is contraindicated in: use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.5)] . available data with fentanyl transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. when administered during gestation through lactation fentanyl administration to pregnant rats resulted in reduced pup survival and developmental delays at doses within the range of the human recommended dosing. no evidence of malformations were noted in animal studies completed to date [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.5)] . opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. fentanyl transdermal system is not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. opioid analgesics, including fentanyl transdermal system, can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. 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. chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures characteristic of neonatal abstinence syndrome in newborn infants. symptoms of neonatal respiratory or neurological depression were no more frequent than expected in most studies of infants born to women treated acutely during labor with intravenous or epidural fentanyl. transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl. no evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered fentanyl continuously via subcutaneously implanted osmotic minipumps at doses of 10, 100, or 500 mcg/kg/day starting 2‑weeks prior to breeding and throughout pregnancy. the high dose was approximately 2 times the daily human dose administered by a 100 mcg/h patch on a mg/m2 basis). in contrast, the intravenous administration of fentanyl (0, 0.01, or 0.03 mg/kg) to pregnant rats from gestation day 6 to 18 suggested evidence of embryo-toxicity and a slight increase in mean delivery time in the 0.03 mg/kg/day group (0.1 times the human dose administered by a 100 mcg/h patch on a mg/m2 basis). there was no clear evidence of teratogenicity noted. pregnant female new zealand white rabbits were treated with fentanyl (0, 0.025, 0.1, 0.4 mg/kg) via intravenous infusion from day 6 to day 18 of pregnancy. fentanyl produced a slight decrease in the body weight of the live fetuses at the high dose, which may be attributed to maternal toxicity. under the conditions of the assay, there was no evidence for fentanyl induced adverse effects on embryo-fetal development at doses up to 0.4 mg/kg (approximately 3 times the daily human dose administered by a 100 mcg/hour patch on a mg/m2 basis). the potential effects of fentanyl on prenatal and postnatal development were examined in the rat model. female wistar rats were treated with 0, 0.025, 0.1, or 0.4 mg/kg/day fentanyl via intravenous infusion from day 6 of pregnancy through 3 weeks of lactation. fentanyl treatment (0.4 mg/kg/day) significantly decreased body weight in male and female pups and also decreased survival in pups at day 4. both the mid-dose and high-dose of fentanyl animals demonstrated alterations in some physical landmarks of development (delayed incisor eruption and eye opening) and transient behavioral development (decreased locomotor activity at day 28 which recovered by day 50). the mid-dose and the high-dose are 0.4 and 1.6 times the daily human dose administered by a 100 mcg/hour patch on a mg/m2 basis. fentanyl is excreted in human milk; therefore, fentanyl transdermal system is not recommended for use in nursing women because of the possibility of effects in their infants. because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with fentanyl transdermal system. monitor infants exposed to fentanyl through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6.2), clinical pharmacology (12.2), nonclinical toxicology (13.1)] . the safety of fentanyl transdermal system was evaluated in three open-label trials in 289 pediatric patients with chronic pain, 2 years of age through 18 years of age. starting doses of 25 mcg/h and higher were used by 181 patients who had been on prior daily opioid doses of at least 45 mg/day of oral morphine or an equianalgesic dose of another opioid. initiation of fentanyl transdermal system therapy in pediatric patients taking less than 60 mg/day of oral morphine or an equianalgesic dose of another opioid has not been evaluated in controlled clinical trials. the safety and effectiveness of fentanyl transdermal system in children under 2 years of age have not been established. to guard against excessive exposure to fentanyl transdermal system by young children, advise caregivers to strictly adhere to recommended fentanyl transdermal system application and disposal instructions [see dosage and administration (2.7) , (2.8) and warnings and precautions (5.4)] . clinical studies of fentanyl transdermal system did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life. moreover, elderly patients may be more sensitive to the active substance than younger patients. a study conducted with the fentanyl transdermal system in elderly patients demonstrated that fentanyl pharmacokinetics did not differ significantly from young adult subjects, although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours [see clinical pharmacology (12.3)] . respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of fentanyl transdermal system slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions (5.12)] . fentanyl is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. the effect of hepatic impairment on the pharmacokinetics of fentanyl transdermal system has not been fully evaluated. a clinical pharmacology study with fentanyl transdermal system in patients with cirrhosis has shown that systemic fentanyl exposure increased in these patients. because there is in vitro and in vivo evidence of extensive hepatic contribution to the elimination of fentanyl transdermal system, hepatic impairment would be expected to have significant effects on the pharmacokinetics of fentanyl transdermal system. avoid use of fentanyl transdermal system in patients with severe hepatic impairment [see dosage and administration (2.5) , warnings and precautions (5.17) and clinical pharmacology (12.3)] . the effect of renal impairment on the pharmacokinetics of fentanyl transdermal system has not been fully evaluated. a clinical pharmacology study with intravenous fentanyl in patients undergoing kidney transplantation has shown that patients with high blood urea nitrogen level had low fentanyl clearance. because there is in vivo evidence of renal contribution to the elimination of fentanyl transdermal system, renal impairment would be expected to have significant effects on the pharmacokinetics of fentanyl transdermal system. avoid the use of fentanyl transdermal system in patients with severe renal impairment [see dosage and administration (2.6) , warnings and precautions (5.18) and clinical pharmacology (12.3)] . fentanyl transdermal system contains fentanyl, a schedule ii controlled substance. fentanyl transdermal system contains fentanyl, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.1)] . misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of fentanyl transdermal system increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent use of fentanyl transdermal system with alcohol and/or other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of fentanyl transdermal system abuse include those with a history of prolonged use of any opioid, including products containing fentanyl, those with a history of drug or alcohol abuse, or those who use fentanyl transdermal system in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. fentanyl transdermal system, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue fentanyl transdermal system in a patient physically dependent on opioids. rapid tapering of fentanyl transdermal system in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing fentanyl transdermal system, gradually taper the dosage using a patient-specific plan that considers the following: the dose of fentanyl transdermal system the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration (2.9), and warnings and precautions (5.21)] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)] .

Verenigde Staten - Engels - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 12 ug in 1 h - fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. patients considered opioid-tolerant are those who are taking 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 for a week or longer. fentanyl transdermal system is contraindicated in the following patients and situations due to the risk of fatal respiratory depression: fentanyl transdermal system is also contraindicated: pregnancy c: there are no adequate and well-controlled studies in pregnant women. fentanyl transdermal system should be used during pregnancy only

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - fentanyl - transdermal patch - 25microgram/1hour

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - fentanyl - transdermal patch - 50microgram/1hour

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - fentanyl - transdermal patch - 75microgram/1hour