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

civica, inc. - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an iv general anesthetic and sedation drug that can be used as described in the table below. indication approved patient population safety, effectiveness and dosing guidelines for propofol have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use. (see precautions - pediatric use . ) propofol is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations. in the intensive care unit (icu), propofol can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses, only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management. propofol is not indicated for use in pediatric icu sedation since the safety of this regimen has

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

civica, inc - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: limitations of use propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see pediatric use (8.4)] . safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use [see pediatric use (8.4)] . propofol injectable emulsion is not indicated for use in pediatric icu sedation since the safety of this regimen has not been established [see pediatric use (8.4)] . propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: - induction of general anesthesia for patients greater than or equal to 3 years of age - maintenance of general anesthesia for patients greater than or equal to 2 months of age - initiation and maintenance of monitored anesthesia care (mac) sedation in adult patients - sedation for adult patients in combination with regional anesthesia - intensive care unit (icu) sedation of intubated, mechanically ventilated adult patients limitations of use propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see pediatric use (8.4)] . safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use [see pediat

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

remedyrepack inc. - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: - induction of general anesthesia for patients greater than or equal to 3 years of age - maintenance of general anesthesia for patients greater than or equal to 2 months of age - initiation and maintenance of monitored anesthesia care (mac) sedation in adult patients - sedation for adult patients in combination with regional anesthesia - intensive care unit (icu) sedation of intubated, mechanically ventilated adult patients limitations of use propofol is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see pediatric use ( 8.4)] . safety, effectiveness and dosing guidelines for propofol have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use [see pediatric use ( 8.4)]. propofol is not indicated for use in pediatric icu sedation since the safety of this regimen has not been established [see pediatric use ( 8.4)]. propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol components. propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products. risk summary data from randomized controlled trials, cohort studies and case series over several decades with propofol use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. most of the reported exposures to propofol describe propofol exposure at the time of cesarean delivery. there are reports of neonatal depression in infants exposed to propofol during delivery (see clinical considerations). in animal reproduction studies, decreased pup survival concurrent with increased maternal mortality was observed with intravenous administration of propofol to pregnant rats either prior to mating and during early gestation or during late gestation and early lactation at exposures less than the human induction dose of 2.5 mg/kg. in pregnant rats administered 15 mg/kg/day intravenous propofol (equivalent to the human induction dose) from two weeks prior to mating to early in gestation (gestation day 7), offspring that were allowed to mate had increased postimplantation losses. the pharmacological activity (anesthesia) of the drug on the mother is probably responsible for the adverse effects seen in the offspring. published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block nmda receptors and/or potentiate gaba activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. there are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [see data , warnings and precautions ( 5.3), use in specific populations ( 8.4)]). the clinical significance of these nonclinical findings is not known, and the benefits of appropriate anesthesia in pregnant women who require procedures should be balanced with the potential risks suggested by the nonclinical 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. clinical considerations fetal/neonatal adverse reactions propofol crosses the placenta and may be associated with neonatal depression. monitor neonates for hypotonia and sedation following maternal exposure to propofol. data animal data pregnant rats were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.3, 0.65, and 1 times the human induction dose of 2.5 mg/kg based on body surface area) during organogenesis (gestational days 6 to 15). propofol did not cause adverse effects to the fetus at exposures up to 1 times the human induction dose despite evidence of maternal toxicity (decreased weight gain in all groups). pregnant rabbits were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.65, 1.3, 2 times the human induction dose of 2.5 mg/kg based on body surface area comparison) during organogenesis (gestation days 6 to 18). propofol treatment decreased total numbers of corpora lutea in all treatment groups but did not cause fetal malformations at any dose despite maternal toxicity (one maternal death from anesthesia-related respiratory depression in the high dose group). pregnant rats were administered propofol intravenously at 0, 10, and 15 mg/kg/day (0.65 and 1 times the human induction dose of 2.5 mg/kg based on body surface area) from late gestation through lactation (gestation day 16 to lactation day 22). decreased pup survival was noted at all doses in the presence of maternal toxicity (deaths from anesthesia-induced respiratory depression). this study did not evaluate neurobehavioral function including learning and memory in the pups. pregnant rats were administered propofol intravenously at 0, 10, or 15 mg/kg/day (0.3 and 1 times the human induction dose of 2.5 mg/kg based on body surface area) from 2 weeks prior to mating to gestational day 7. pup (f1) survival was decreased on day 15 and 22 of lactation at maternally toxic doses of 10 and 15 mg/kg/day. when f1 offspring were allowed to mate, postimplantation losses were increased in the 15 mg/kg/day treatment group. in a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on gestation day 122 increased neuronal apoptosis in the developing brain of the fetus. in other published studies, administration of either isoflurane or propofol for 5 hours on gestation day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. with respect to brain development, this time period corresponds to the third trimester of gestation in the human. the clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits [see warnings and precautions ( 5.3), pediatric use ( 8.4), and animal toxicology and/or pharmacology ( 13.2)] . risk summary based on data from published studies, propofol is present in human milk. variable concentrations have been reported in human milk with administration of propofol to nursing mothers in the early post-partum period. available data have not shown adverse reactions in breastfed infants. there are no data on the effects of propofol on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for propofol and any potential adverse effects on the breastfed infant form propofol or from the underlying maternal condition. the safety and effectiveness of propofol have been established for induction of anesthesia in pediatric patients aged 3 years and older and for the maintenance of anesthesia aged 2 months and older. in pediatric patients, administration of fentanyl concomitantly with propofol may result in serious bradycardia [see warnings and precautions ( 5.4)] . propofol is not indicated for use in pediatric patients for icu sedation or for mac sedation for surgical, nonsurgical or diagnostic procedures as safety and effectiveness have not been established. there have been anecdotal reports of serious adverse events and death in pediatric patients with upper respiratory tract infections receiving propofol for icu sedation. in one multicenter clinical trial of icu sedation in critically ill pediatric patients that excluded patients with upper respiratory tract infections, the incidence of mortality observed in patients who received propofol (n=222) was 9%, while that for patients who received standard sedative agents (n=105) was 4%. while causality was not established in this study, propofol is not indicated for icu sedation in pediatric patients until further studies have been performed to document its safety in that population [see clinical pharmacology ( 12.3) and dosage and administration ( 2.1 and 2.2)] . however, propofol infusions are routinely used to provide safe sedation to critically ill pediatric patients in icus. in pediatric patients, abrupt discontinuation of propofol following prolonged infusion may result in flushing of the hands and feet, agitation, tremulousness and hyperirritability. increased incidences of bradycardia (5%), agitation (4%), and jitteriness (9%) have also been observed. published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as propofol, that either block nmda receptors or potentiate the activity of gaba during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately 3 years of age in humans. in primates, exposure to 3 hours of ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. data from isoflurane-treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory. the clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in pregnant women, neonates, and young children who require procedures with the potential risks suggested by the nonclinical data [see warnings and precaution ( 5.3), pregnancy ( 8.1), and animal toxicology and/or pharmacology ( 13.2)] . the effect of age on induction dose requirements for propofol was assessed in an open-label study involving 211 unpremedicated patients with approximately 30 patients in each decade between the ages of 16 and 80. the average dose to induce anesthesia was calculated for patients up to 54 years of age and for patients 55 years of age or older. the average dose to induce anesthesia in patients up to 54 years of age was 1.99 mg/kg and in patients above 54 it was 1.66 mg/kg. subsequent clinical studies have demonstrated lower dosing requirements for subjects greater than 60 years of age. a lower induction dose and a slower maintenance rate of administration of propofol should be used in elderly patients. in this group of patients, rapid (single or repeated) bolus administration should not be used in order to minimize undesirable cardiorespiratory depression. all dosing should be titrated according to patient condition and response [see dosage and administration ( 2) and clinical pharmacology ( 12.3)]. the long-term administration of propofol to patients with hepatic insufficiency has not been evaluated. the pharmacokinetics of propofol do not appear to be different in people with chronic hepatic cirrhosis compared to adults with normal hepatic function. the effects of acute hepatic failure on the pharmacokinetics of propofol have not been studied. the long-term administration of propofol to patients with renal failure has not been evaluated. the pharmacokinetics of propofol do not appear to be different in people with chronic renal impairment compared to adults with normal renal function. the effects of acute renal failure on the pharmacokinetics of propofol have not been studied. there are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. instances of self-administration of propofol injectable emulsion by health care professionals have also been reported, which have resulted in fatalities and other injuries. inventories of propofol should be stored and managed to prevent the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting.

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

henry schein, inc. - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an iv general anesthetic and sedation drug that can be used as described in the table below. safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use (see precautions , pediatric use ). propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations. in the intensive care unit (icu), propofol injectable emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management. propofol injectable emulsion is not indicated for use in pediatric icu sedation

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

northstar rx llc - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: - induction of general anesthesia for patients greater than or equal to 3 years of age - maintenance of general anesthesia for patients greater than or equal to 2 months of age - initiation and maintenance of monitored anesthesia care (mac) sedation in adult patients - sedation for adult patients in combination with regional anesthesia - intensive care unit (icu) sedation of intubated, mechanically ventilated adult patients limitations of use propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see pediatric use (8.4)] . safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use [see pediat

Canada - English - Health Canada

pfizer canada ulc - propofol - emulsion - 10mg - propofol 10mg - miscellaneous general anesthetics

Canada - English - Health Canada

pfizer canada ulc - propofol - emulsion - 10mg - propofol 10mg - miscellaneous general anesthetics

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

baxter healthcare pty ltd - propofol, quantity: 1000 mg - injection, emulsion - excipient ingredients: water for injections; glycerol; soya oil; medium chain triglycerides; sodium oleate; egg lecithin; sodium hydroxide - short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children aged three years and older. provive mct-lct 1% has no analgesic properties. although the safety and efficacy of propofol in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. provive mct-lct 1% may also be used in adults for sedation of ventilated patients receiving intensive care. provive mct-lct 1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.

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

baxter healthcare pty ltd - propofol, quantity: 500 mg - injection, emulsion - excipient ingredients: glycerol; soya oil; sodium hydroxide; medium chain triglycerides; water for injections; egg lecithin; sodium oleate - short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children aged three years and older. provive mct-lct 1% has no analgesic properties. although the safety and efficacy of propofol in paediatric day surgery have not been demonstrated, it may be a useful agent in this setting and its use should not be precluded. provive mct-lct 1% may also be used in adults for sedation of ventilated patients receiving intensive care. provive mct-lct 1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.