Canada - engleză - Health Canada

bavarian nordic as - inactivated rabies virus (flury lep) - powder for solution - 2.5unit - inactivated rabies virus (flury lep) 2.5unit - vaccines

Statele Unite ale Americii - engleză - 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 .

Malaezia - engleză - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - inactivated rabies virus -

Filipine - engleză - FDA (Food And Drug Administration)

zoetis philippines, inc.; distributor: zoetis philippines, inc. - inactivated rabies vaccine (vet.) - suspension for injection (im/sc) - formulation: each 1 ml (dose) contains: rabies virus (pv-paris, svr-289 strain) ... tcid - tissue culture infective dose ... > 107.35 tcid50 (before inactivation)

Israel - engleză - Ministry of Health

padagis israel agencies ltd, israel - rabies immunoglobulin - solution for injection - rabies immunoglobulin 150 iu/ml - rabies immunoglobulin - rabies immunoglobulin - to be given in conjunction with rabies vaccine as promptly as possible after exposure.

Regatul Unit - engleză - VMD (Veterinary Medicines Directorate)

boehringer ingelheim animal health uk ltd - rabies virus - suspension for injection - inactivated viral vaccine - cats, dogs

Armenia - engleză - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

fsue of chumakov ipve - specific antigen of rabies virus vnukovo-32 strain - lyophilisate for solution for i/m injection - 2.5iu/ml

Belgia - engleză - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international b.v. - rabies virus (inactivated) >= 2 iu/dose - suspension for injection - rabies virus, inactivated - rabies virus - cattle; dog; horse; cat; sheep

Armenia - engleză - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

federal state budgetary scientific institution chumakov federal scientific center for research and development of immune-and-bio - specific antigen of rabies virus vnukovo-32 strain - lyophilisate for solution for i/m injection - 2.5iu/ml

Zimbabwe - engleză - Medicines Control Authority

zoetis south africa (pty) ltd - rabies virus (killed) - vaccine - 10^7.4 tcid50