アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - isopropyl alcohol (unii: nd2m416302) (isopropyl alcohol - unii:nd2m416302) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available. - in children less than 2 months of age - on open skin wounds stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

phytogenx, inc. - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z), titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp), octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51) -

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

argenx us - efgartigimod alfa (unii: 961yv2o515) (efgartigimod alfa - unii:961yv2o515) - vyvgart is indicated for the treatment of generalized myasthenia gravis (gmg) in adult patients who are anti-acetylcholine receptor (achr) antibody positive. vyvgart is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products or to any of the excipients of vyvgart. reactions have included anaphylaxis and hypotension leading to syncope [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to vyvgart during pregnancy. healthcare providers and patients may call 1-855-272-6524 or go to https://www.vyvgartpregnancy.com to enroll in or to obtain information about the registry. risk summary there are no available data on the use of vyvgart during pregnancy. there is no evidence of adverse developmental outcomes following the administration of vyvgart at up to 100 mg/kg/day in rats and rabbits (see data). the background rate of major birth defects and miscarriage in the indicated population is unknown. in the u.s. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. therefore, efgartigimod alfa-fcab may be transmitted from the mother to the developing fetus. as vyvgart is expected to reduce maternal igg antibody levels, reduction in passive protection to the newborn is anticipated. risk and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to vyvgart in utero [see warnings and precautions (5.1)]. data animal data intravenous administration of efgartigimod alfa-fcab (0, 30, or 100 mg/kg/day) to pregnant rats and rabbits throughout organogenesis resulted in no adverse effects on embryofetal development in either species. the doses tested are 3 and 10 times the recommended human dose (rhd) of 10 mg/kg, on a body weight (mg/kg) basis. intravenous administration of efgartigimod alfa-fcab (0, 30, or 100 mg/kg/day) to rats throughout gestation and lactation resulted in no adverse effects on pre- or postnatal development. the doses tested are 3 and 10 times the recommended human dose (rhd) of 10 mg/kg, on a body weight (mg/kg) basis. risk summary there is no information regarding the presence of efgartigimod alfa-fcab in human milk, the effects on the breastfed infant, or the effects on milk production. maternal igg is known to be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vyvgart and any potential adverse effects on the breastfed infant from vyvgart or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of vyvgart did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients. no dose adjustment of vyvgart is needed for patients with mild renal impairment. there are insufficient data to evaluate the impact of moderate renal impairment (egfr 30-59 ml/min/1.73 m2 ) and severe renal impairment (egfr <30 ml/min/1.73 m2 ) on pharmacokinetic parameters of efgartigimod alfa-fcab [see clinical pharmacology (12.3)].