Združene države Amerike - angleščina - NLM (National Library of Medicine)

akebia therapeutics, inc. - tetraferric tricitrate decahydrate (unii: q91187k011) (ferric cation - unii:91o4lml611) - ferric cation 210 mg - auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. auryxia is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see warnings and precautions (5.1)] . risk summary there are no available data on auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted using auryxia. skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9. however, oral administration of other ferric or ferrous compounds to gravid cd1-mice and wistar-rats caused no fetal malformation. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. clinical considerations the effect of auryxia on the absorption of vitamins and other nutrients has not been studied in pregnant women. requirements for vitamins and other nutrients are increased in pregnancy. risk summary there are no human data regarding the effect of auryxia in human milk, the effects on the breastfed child, or the effects on milk production. data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (dmt-1) and ferroportin-1 (fpn-1). hence, there is a possibility of infant exposure when auryxia is administered to a nursing woman. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for auryxia and any potential adverse effects on the breastfed child from auryxia or from the underlying maternal condition. the safety and efficacy of auryxia have not been established in pediatric patients. juvenile animal toxicity data in animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. because auryxia is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity. clinical studies of auryxia included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of auryxia.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lydia co., ltd. - rhubarb (unii: g280w4mw6e) (rhubarb - unii:g280w4mw6e), rehmannia glutinosa root (unii: 1bem3u6lqq) (rehmannia glutinosa root - unii:1bem3u6lqq), angelica gigas root (unii: 32766b2fhx) (angelica gigas root - unii:32766b2fhx), akebia stem (unii: 531b9g152h) (akebia stem - unii:531b9g152h), scutellaria baicalensis root (unii: 7j95k7id2s) (scutellaria baicalensis root - unii:7j95k7id2s), licorice (unii: 61zbx54883) (licorice - unii:61zbx54883), alisma plantago-aquatica root (unii: 6dxr2088wl) (alisma pl - bladder qatar, urethritis, kidney disease, nephrotic syndrome, edema adults: 3~6 tablets twice a day 7 to 14 years old: 2-3 tablets twice a day

Singapur - angleščina - HSA (Health Sciences Authority)

999 - granules

Singapur - angleščina - HSA (Health Sciences Authority)

nong's - granules

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

tong jum chew (m) sdn. bhd. - acorus tatarinowii; akebia trifoliata; amomum kravanh; artemisia scoparia; forsythia suspensa; fritillaria cirrhosa; mentha haplocalyx; pogostemon cablin; scutellaria baicalensis; talcum; belamcanda chinensis -

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

bio nice herbal world sdn bhd - acorus gramineus; akebia quinata; amomum rotundus; artemisia scoparia; forsythia suspensa; fritillaria cirrhosa; mentha haplocalyx; pogostemon cablin; scutellaria baicalensis; talcum; belamcanda chinensis -

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

anhong trading sdn. bhd. - herba polygonum chinensis linn; ziziphus sativa; imperatae radix; honey, purified; glehniae radix; flos lonicerae; flos chrysanthemi; akebia (caulis) -

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

high mean (m) sdn bhd - talcum; rhizoma belamcandae; rhizoma acori graminei; radix scuteliariae; herba menthae; herba agastachis; fructus forsythiae; fructus amomi rotundus; caulis akebiae; bulbus fritillariae cirrhosae; artemisiae scopariae herba -

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

yilin (m) sdn. bhd. - rhizoma belamcandae chinensis; rhizoma acori graminei; herba pogostemonis cablin; fructus amomi rotundus; caulis akebiae trifoliata; bulbus fritillariae cirrhosae; artemisiae scopariae herba; radix scutellaria baicalensis; fructus forsythiae suspensa -

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

yilin (m) sdn. bhd. - gentiana scabra; semen plantaginis; scutellaria baicalensis radix; radix rehmannia glutinosa; radix bupleurum chinense; radix angelicae sinensis extract; glycyrrhiza uralensis radix; gardeniae jasminoides fructus; caulis akebiae trifoliata; alismatis orientale rhizoma -