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

sun pharma advanced research company limited - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 1000 mg - elepsia xr is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. elepsia xr is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including elepsia xr, during pregnancy. encourage women who are taking elepsia xr 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 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, levetirac

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

celgene corporation - ozanimod hydrochloride (unii: 3upr33jaam) (ozanimod - unii:z80293urpv) - zeposia is indicated for the treatment of: zeposia is contraindicated in patients who: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zeposia during pregnancy. healthcare providers are encouraged to register patients on-line, or pregnant women may register themselves at https://www.zeposiapregnancyregistry.com/or by calling 1-877-301-9314. currently this registry is enrolling women with ms. information regarding registration of pregnant women with uc will be made available in the future. risk summary there are no adequate data on the developmental risk associated with the use of zeposia in pregnant women. in animal studies, administration of ozanimod during pregnancy produced adverse effects on development, including embryolethality, an increase in fetal malformations, and neurobehavioral changes, in the absence of maternal toxicity. in rabbits, fetal blood vessel malformations occurred at clinically relevant maternal ozanimod and metab

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

tripoint therapeutics, llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - elepsia xr is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. elepsia xr is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including elepsia xr, during pregnancy. encourage women who are taking elepsia xr 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 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 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 development 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 elepsia xr 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 elepsia xr and any potential adverse effects on the breastfed infant from elepsia xr or from the underlying maternal condition. safety and effectiveness of elepsia xr in pediatric patients 12 years of age and older has been established based on pharmacokinetic data in adults and adolescents using levetiracetam extended-release tablets and efficacy and safety data in controlled pediatric studies using immediate-release levetiracetam tablets [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)]. safety and effectiveness in pediatric patients below the age of 12 years have not been established. a 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release levetiracetam tablets as adjunctive therapy in 98 pediatric patients with inadequately controlled partial seizures, ages 4 to 16 years (levetiracetam n=64; placebo n=34). the target dose of immediate-release levetiracetam tablets was 60 mg/kg/day. neurocognitive effects were measured by the leiter-r attention and memory (am) battery, which assesses various aspects of a child's memory and attention. although no substantive differences were observed between the placebo-and levetiracetam-treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority between 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 a worsening in aggressive behavior, one of the eight syndrome scores, in patients treated with levetiracetam [see warnings and precautions (5.1)]. juvenile animal toxicity data studies of levetiracetam in juvenile rats (dosing from day 4 through day 52 of age) and dogs (dosing from week 3 through week 7 of age) at doses of up to 1,800 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 indicate a potential for age-specific toxicity. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam extended-release tablets in these patients. it is expected that the safety of elepsia xr in elderly patients 65 and over would be comparable to the safety observed in clinical studies of immediate-release levetiracetam tablets. there were 347 subjects in clinical studies of immediate-release levetiracetam that were 65 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 immediate-release levetiracetam tablets 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)] . dose adjustment is recommended for patients with mild renal impairment [see dosage and administration (2.2)] . elepsia xr is not recommended in patients with moderate or severe renal impairment. in patients with moderate or severe renal impairment, it is recommended that lower strength levetiracetam tablets be used instead of elepsia xr. in patients with end stage renal disease on dialysis, it is recommended that immediate-release levetiracetam tablets be used instead of elepsia xr.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

anudha limited, tanzania - anaesthesia system -

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

baxter healthcare pty ltd - propofol, quantity: 1000 mg - injection, emulsion - excipient ingredients: soya oil; glycerol; egg lecithin; sodium oleate; sodium hydroxide; water for injections - short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children aged three years and older. anesia 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. anesia 1% may also be used in adults for sedation of ventilated patients receiving intensive care. anesia1% 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: soya oil; glycerol; egg lecithin; sodium oleate; sodium hydroxide; water for injections - short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children aged three years and older. anesia1% 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. anesia 1% may also be used in adults for sedation of ventilated patients receiving intensive care. anesia 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: 200 mg - injection, emulsion - excipient ingredients: sodium oleate; glycerol; egg lecithin; sodium hydroxide; water for injections; soya oil - short acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults and children aged three years and older. anesia 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. anesia 1% may also be used in adults for sedation of ventilated patients receiving intensive care. anesia 1% may also be used in adults for monitored conscious sedation for surgical and diagnostic procedures.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - ozanimod as hydrochloride - capsules - ozanimod as hydrochloride 0.23 mg - ozanimod - zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features.zeposia is indicated for the treatment of moderately to severely active ulcerative colitis (uc) in adults.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - ozanimod as hydrochloride - capsules - ozanimod as hydrochloride 0.46 mg - ozanimod - zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features.zeposia is indicated for the treatment of moderately to severely active ulcerative colitis (uc) in adults.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - ozanimod as hydrochloride - capsules - ozanimod as hydrochloride 0.92 mg - ozanimod - zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features.zeposia is indicated for the treatment of moderately to severely active ulcerative colitis (uc) in adults.