미국 - 영어 - NLM (National Library of Medicine)

reata pharmaceuticals, inc. - omaveloxolone (unii: g69z98951q) (omaveloxolone - unii:g69z98951q) - skyclarys is indicated for the treatment of friedreich's ataxia in adults and adolescents aged 16 years and older. none. risk summary there are no adequate data on the developmental risks associated with the use of skyclarys in pregnant women. in animal studies, administration of omaveloxolone during pregnancy or throughout pregnancy and lactation produced evidence of developmental toxicity (embryofetal mortality and growth impairment, and mortality, growth impairment, and neurobehavioral deficits in offspring) at plasma exposures similar to or less than exposures in humans (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% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of omaveloxolone (0, 1, 3, or 10 mg/kg/day) to pregnant rats throughout organogenesis resulted in no adverse effects on embryofetal development; however, in a dose range-finding study, oral administration of omaveloxolone at doses up to 30 mg/kg/day to pregnant rats throughout organogenesis produced increases in post-implantation loss and resorptions, resulting in a decrease in viable fetuses, and reduced fetal weight at the highest dose tested. at the highest dose tested in the pivotal study (10 mg/kg/day), plasma exposure (auc) was approximately 5 times that in humans at the recommended human dose (rhd) of 150 mg/day. oral administration of omaveloxolone (0, 3, 10, or 30 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in increased embryofetal mortality and skeletal variations and reduced fetal weight at the highest dose tested, which was associated with maternal toxicity. at the no-effect dose for adverse effects on embryofetal development (10 mg/kg/day), plasma exposure was less than that in humans at the rhd. oral administration of omaveloxolone (0, 1, 3, or 10 mg/kg/day) to rats throughout pregnancy and lactation resulted in an increase in stillbirths and impaired neurobehavioral function (increased locomotor activity and learning and memory deficits) in offspring at all doses, reduced body weight in offspring at all but the lowest dose tested, and delayed sexual maturation (males), increased postnatal mortality, and impaired reproductive performance in offspring at the highest dose tested. a no-effect dose for adverse effects on pre- and postnatal development was not identified. plasma exposure (auc) at the lowest dose tested was less than that in humans at the rhd. risk summary there are no data on the presence of omaveloxolone or its metabolites in human milk. the effects on milk production and the breastfed infant are unknown. omaveloxolone was excreted in the milk of lactating rats following oral administration. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for skyclarys and any potential adverse effects on the breastfed infant from skyclarys or from the underlying maternal condition. skyclarys may decrease the efficacy of hormonal contraceptives [see drug interactions (7.2) and clinical pharmacology (12.3)] . advise patients to avoid concomitant use with combined hormonal contraceptives (e.g., pill, patch, ring), implants, and progestin only pills. counsel females using hormonal contraceptives to use an alternative contraceptive method (e.g., non-hormonal intrauterine system) or additional non-hormonal contraceptive (e.g., condoms) during concomitant use and for 28 days after discontinuation of skyclarys. the safety and effectiveness of skyclarys for the treatment of friedreich's ataxia have been established in pediatric patients aged 16 years and older. use of skyclarys for this indication is supported by evidence from one adequate and well-controlled study (study 1) in adults and in pediatric patients aged 16 years and older [see clinical studies (14)] . safety and effectiveness of skyclarys have not been established in pediatric patients less than 16 years of age. clinical studies of skyclarys in friedreich's ataxia did not include patients aged 65 and over. no data are available to determine whether they respond differently than younger adult patients. omaveloxolone plasma exposure is increased in patients with moderate or severe hepatic impairment (child-pugh class b and c) [see clinical pharmacology (12.3)] . avoid treatment with skyclarys in patients with severe hepatic impairment, including those who develop severe hepatic impairment. if hepatic function improves to moderate impairment, mild impairment, or normal function, initiation of skyclarys treatment at the approved recommended dosage may be considered. for patients with moderate hepatic impairment, a reduced dosage is recommended with close monitoring for adverse reactions [see dosage and administration (2.5)] . for patients with mild hepatic impairment (child-pugh class a), no dose adjustments are recommended.

싱가포르 - 영어 - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - moxifloxacin hcl eqv moxifloxacin - injection - 400 mg/250 ml - moxifloxacin hcl eqv moxifloxacin 400 mg/250 ml

싱가포르 - 영어 - HSA (Health Sciences Authority)

bayer (south east asia) pte ltd - moxifloxacin hcl eqv moxifloxacin - tablet, film coated - 400 mg - moxifloxacin hcl eqv moxifloxacin 400 mg

말레이시아 - 영어 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

bayer co. (malaysia) sdn. bhd. - moxifloxacin hcl -

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - moxifloxacin -

탄자니아 - 영어 - Tanzania Medicinces & Medical Devices Authority

bayer east africa limited, kenya - avelox iv - infusion - 400 mg

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

bayer limited - moxifloxacin - film-coated tablet - 400 milligram(s) - fluoroquinolones; moxifloxacin

몰타 - 영어 - Medicines Authority

bayer public limited company - moxifloxacin - film-coated tablet - moxifloxacin 400 milligram(s) - antibacterials for systemic use

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

ltt pharma limited - moxifloxacin hydrochloride - film coated tablet - 400 milligram - fluoroquinolones - quinolone antibacterials, fluoroquinolones - it is indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin: - acute bacterial sinusitis (adequately diagnosed) - acute exacerbations of chronic bronchitis (adequately diagnosed) - community acquired pneumonia, except severe cases - mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess. it may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications: - community-acquired pneumonia - complicated skin and skin structure infections

영국 - 영어 - MHRA (Medicines & Healthcare Products Regulatory Agency)

bayer plc - moxifloxacin hydrochloride - oral tablet - 400mg