アイルランド - 英語 - HPRA (Health Products Regulatory Authority)

gsk vaccines gmbh - rabies virus (flury lep) inactivated - infus/pdr/oral soln - >= 2.5 international unit(s)/millilitre - rabies vaccines; rabies, inactivated, whole virus

ノルウェー - ノルウェー語 - Statens legemiddelverk

sanofi pasteur europe - rabiesvirus, stammee wistar rabies pm/wi 38-1503-3m, inaktivert - pulver og væske til injeksjonsvæske, suspensjon - 2.5 ie/ dose

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

kedrion biopharma inc. - human rabies virus immune globulin (unii: 95f619atq2) (human rabies virus immune globulin - unii:95f619atq2) - kedrab is a human rabies immune globulin (hrig) indicated for passive, transient post-exposure prophylaxis (pep) of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. kedrab should be administered concurrently with a full course of rabies vaccine. none. risk summary kedrab has not been studied in pregnant women. therefore, the risk of major birth defects and miscarriage in pregnant women who are exposed to kedrab is unknown. animal developmental or reproduction toxicity studies have not been conducted with kedrab. it is not known whether kedrab can cause harm to the fetus when administered to a pregnant woman or whether kedrab can affect reproductive capacity. in the u.s. general population, the estimated background of major birth defects occurs in 2-4% of the general population and miscarriage occurs in 15-20% of clinically recognized pregnancies. risk summary there is no information regarding the presence of kedrab in human milk, the effects 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 kedrab and any potential adverse effects on the breastfed infant from kedrab or from the underlying maternal condition. safety and effectiveness have been established in children. in a pediatric study of 30 patients ranging in age from 0.5 to 14.9 years, kedrab presented no serious adverse reactions through day 84. of the 30 patients, 28 (93.3%) achieved a day-14 rvna titer ≥0.5 iu/ml, the who recommended level. none of the patients who were followed until the end of the study (28/30 patients) developed rabies infection through day 84. [see clinical trials ( 14)] adverse reactions that occurred in ≥3.3% of patients within the first 14 days of kedrab and the first rabies vaccination administration are listed in section 6.1. the clinical trial conducted in the pediatric population is described in section 14. additional evidence to support the use of kedrab in children comes from real world evidence. based on claims data, 172 u.s. children (≤17 years) were treated with kedrab between 2018-2020. based on center for disease control data, no children in the u.s. treated with post-exposure prophylaxis have been reported to have had rabies between 2018-april 2021. clinical studies of kedrab did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. clinical experience with hrig products has not identified differences in effectiveness between elderly and younger patients (acip) 1 .

スウェーデン - スウェーデン語 - Läkemedelsverket (Medical Products Agency)

sanofi pasteur europe - rabiesvirus, stam wistar pm/wi 38-1503-3m, inaktiverat - pulver och vätska till injektionsvätska, suspension - 2,5 iu - rabiesvirus, stam wistar pm/wi 38-1503-3m, inaktiverat 2,5 ie aktiv substans - inaktiverat helvirusvaccin

ハンガリー - ハンガリー語 - OGYÉI (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézetről)

human bioplazma kft. - humán albumin oldat -

ハンガリー - ハンガリー語 - OGYÉI (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézetről)

human bioplazma kft. - humán albumin oldat -

ハンガリー - ハンガリー語 - OGYÉI (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézetről)

human bioplazma kft. - humán albumin oldat -

ドイツ - ドイツ語 - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

deutsche gesellschaft für gewebetransplantation ggmbh (4600754) - humanes blutgefäß - transplantat humanen ursprungs - teil 1 - transplantat humanen ursprungs; humanes blutgefäß (38409) 1 stück

ドイツ - ドイツ語 - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

deutsche gesellschaft für gewebetransplantation ggmbh (4600754) - humane herzklappe - transplantat humanen ursprungs - teil 1 - transplantat humanen ursprungs; humane herzklappe (38410) 1 stück

カナダ - 英語 - Health Canada

grifols therapeutics llc - immunoglobulin (human) - solution - 18% - immunoglobulin (human) 18% - serums