Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987) - lidocaine hcl injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.  lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam injection is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions  (5.3) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam injection, during pregnancy. encourage women who are taking levetiracetam injection during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary prolonged experience with levetiracetam injection in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries, and reflects experience over two decades [see human data ] . in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal data ] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.9) ] . physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. data human data while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. animal data when levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal developmental in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre-and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the mrhd on a mg/m2 basis).   risk summary levetiracetam is excreted in human milk. there are no data on the effects of levetiracetam injection on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for levetiracetam injection and any potential adverse effects on the breastfed infant from levetiracetam injection or from the underlying maternal condition. the safety and effectiveness of levetiracetam injection for the treatment of partial onset seizures in patients 1 month to 16 years of age have been established [see clinical pharmacology (12.3) and clinical studies (14.1) ] . the dosing recommendation in these pediatric patients varies according to age group and is weight-based [see dosage and administration (2.6) ] . the safety and effectiveness of levetiracetam injection as adjunctive therapy for the treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established [see clinical studies (14.2) ] . the safety and effectiveness of levetiracetam injection as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established [see clinical studies (14.3) ] . safety and effectiveness for the treatment of partial-onset seizures in pediatric patients below the age of 1 month; adjunctive therapy for the treatment of myoclonic seizures in pediatric patients below the age of 12 years; and adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients below the age of 6 years have not been established. a 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam injection as adjunctive therapy in 98 (levetiracetam injection n=64, placebo n=34) pediatric patients, ages 4 years to 16 years, with partial seizures that were inadequately controlled. the target dose was 60 mg/kg/day. neurocognitive effects were measured by the leiter-r attention and memory (am) battery, which measures various aspects of a child's memory and attention. although no substantive differences were observed between the placebo and drug treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority of the drug and placebo. the achenbach child behavior checklist (cbcl/6-18), a standardized validated tool used to assess a child’s competencies and behavioral/emotional problems, was also assessed in this study. an analysis of the cbcl/6-18 indicated, on average, a worsening in levetiracetam injection-treated patients in aggressive behavior, one of the eight syndrome scores [see warnings and precautions (5.1) ]. juvenile animal toxicity data studies of levetiracetam in juvenile rats (dosed on postnatal days 4 through 52) and dogs (dosed from postnatal weeks 3 through 7) at doses of up to 1800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m2 basis) did not demonstrate adverse effects on postnatal development. there were 347 subjects in clinical studies of levetiracetam that were 65 years old and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam injection in these patients. levetiracetam 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 monitor renal function [see clinical pharmacology (12.3) ] . clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3) ] . dosage adjustment is recommended for patients with impaired renal function and supplemental doses should be given to patients after dialysis [see dosage and administration ( 2.7 ) ] .

Sjedinjene Američke Države - engleski - 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

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (gerd) and a history of erosive esophagitis (ee). safety and efficacy of pantoprazole sodium for injection as a treatment of patients with gerd and a history of ee for more than 10 days have not been demonstrated. pantoprazole sodium for injection is indicated for the treatment of pathological hypersecretory conditions including zollinger-ellison (ze) syndrome in adults. risk summary available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. in animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with ad

Sjedinjene Američke Države - engleski - 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

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate is an opioid agonist indicated for the management of pain not responsive to non-narcotic analgesics. - morphine sulfate is contraindicated in patients with known hypersensitivity to morphine. - morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. - morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. - morphine sulfate is contraindicated in any patient who has or is suspected of having a paralytic ileus. teratogenic effects (pregnancy category c) no formal studies to assess the teratogenic effects of morphine in animals have been conducted. it is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. morphine should be given to a pregnant woman only if clearly needed. in humans, the frequency of congenital anomalies have been reported to be no greater than expected among the children of 70 women who were tre

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection is indicated for: - treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older [see clinical studies (14.1) and use in specific populations (8.4)]. - treatment of esophageal candidiasis in adult and pediatric patients 4 months of age and older [see clinical studies (14.2)]. - prophylaxis of candida infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see clinical studies (14.3)]. limitations of use - micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to candida . - the efficacy of micafungin for injection against infections caused by fungi other than candida has not been established. additional pediatric use information is approved for astellas pharma us, inc.`s mycamine® (micafungin for injection). however, due to astellas pharma us, inc.`s marketing exclusivity rights, this drug product is not labeled with that information. micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin for injection, or other echinocandins. risk summary based on findings from animal studies, micafungin for injection may cause fetal harm when administered to a pregnant woman (see data). there is insufficient human data on the use of micafungin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, intravenous administration of micafungin sodium to pregnant rabbits during organogenesis at doses four times the maximum recommended human dose resulted in visceral abnormalities and increased abortion (see data) . advise pregnant women of the risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations 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 to 4% and 15 to 20%, respectively. data animal data in an embryo-fetal toxicity study in pregnant rabbits, intravenous administration of micafungin sodium during organogenesis (days 6 to 18 of gestation) resulted in fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to four times the recommended human dose based on body surface area comparisons. visceral abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter. risk summary there are no data on the presence of micafungin in human milk, the effects on the breast-fed infant or the effects on milk production. micafungin was present in the milk of lactating rats following intravenous administration. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for micafungin for injection, and any potential adverse effects on the breast-fed child from micafungin for injection, or from the underlying maternal condition. pediatric patients 4 months of age and older the safety and effectiveness of micafungin for injection for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis, candida peritonitis and abscesses, esophageal candidiasis, and for prophylaxis of candida infections in patients undergoing hsct have been established in pediatric patients 4 months of age and older. use of micafungin for injection for these indications and in this age group is supported by evidence from adequate and well-controlled studies in adult and pediatric patients with additional pharmacokinetic and safety data in pediatric patients 4 months of age and older [see indications and usage (1), adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . pediatric patients younger than 4 months of age treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age the safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age. in a rabbit model of hematogenous candida meningoencephalitis (hcme) with candida albicans (minimum inhibitory concentration of 0.125 mcg/ml), a decrease in mean fungal burden in central nervous system (cns) compartments assessed as the average of combined fungal burden in the cerebrum, cerebellum, and spinal cord relative to untreated controls, was observed with increasing micafungin dosages administered once daily for 7 days. in this rabbit model, micafungin concentrations could not be reliably detected in cerebrospinal fluid (csf). due to limitations of the study design, the clinical significance of a decreased cns fungal burden in the rabbit hcme model is uncertain. treatment of esophageal candidiasis and prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation in pediatric patients younger than 4 months of age the safety and effectiveness of micafungin for injection in pediatric patients younger than 4 months of age have not been established for the: - treatment of esophageal candidiasis - prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation additional pediatric use information is approved for astellas pharma us, inc.`s mycamine® (micafungin for injection). however, due to astellas pharma us, inc.`s marketing exclusivity rights, this drug product is not labeled with that information. a total of 418 subjects in clinical studies of micafungin for injection were 65 years of age and older, and 124 subjects were 75 years of age and older. no overall differences in safety and effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the exposure and disposition of a 50 mg micafungin for injection dose administered as a single 1-hour infusion to 10 healthy subjects aged 66 to 78 years were not significantly different from those in 10 healthy subjects aged 20 to 24 years. no dose adjustment is necessary for the elderly. micafungin for injection does not require dose adjustment in patients with renal impairment. supplementary dosing should not be required following hemodialysis [see clinical pharmacology (12.3)] . dose adjustment of micafungin for injection is not required in patients with mild, moderate, or severe hepatic impairment [see clinical pharmacology (12.3)] . no dose adjustment of micafungin for injection is required based on gender or race. after 14 daily doses of 150 mg to healthy subjects, micafungin auc in women was greater by approximately 23% compared with men, due to smaller body weight. no notable differences among white, black, and hispanic subjects were seen. the micafungin auc was greater by 19% in japanese subjects compared to blacks, due to smaller body weight. there has been no evidence of either psychological or physical dependence or withdrawal or rebound effects with micafungin for injection.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. surgical anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration acute pain management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. risk summary there are no available human data on use of ropivacaine hydrochloride injection in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see clinical considerations) . no teratogenicity was observed at dos

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp is effective in the treatment of staphylococcal endocarditis. its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. when staphylococcal infecti

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (ß-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp is effective in the treatment of staphylococcal endocarditis. its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. when staphylococcal infecti