Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - hepatitis b immunoglobulin human - solution for injection - 100unit/1ml

Stati Uniti - inglese - NLM (National Library of Medicine)

a-s medication solutions - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 10 ug in 1 ml - recombivax hb® [hepatitis b vaccine, recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. recombivax hb is approved for use in individuals of all ages. recombivax hb dialysis formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older. do not administer recombivax hb to individuals with a history of severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis b-containing vaccine or to any component of recombivax hb, including yeast [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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. there are no adequate and well-controlled studies designed to evaluate recombivax hb in pregnant women. available post-approval data do not suggest an in

Stati Uniti - inglese - NLM (National Library of Medicine)

dynavax technologies corporation - hepatitis b virus subtype adw hbsag surface protein antigen (unii: xl4hlc6jh6) (hepatitis b virus subtype adw hbsag surface protein antigen - unii:xl4hlc6jh6) - hepatitis b virus subtype adw hbsag surface protein antigen 20 ug in 0.5 ml - heplisav-b is indicated for prevention of infection caused by all known subtypes of hepatitis b virus. heplisav-b is approved for use in adults 18 years of age and older. do not administer heplisav-b to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis b vaccine or to any component of heplisav-b, including yeast [see description (11)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to heplisav-b during pregnancy. women who receive heplisav-b during pregnancy are encouraged to contact 1-844-443-7734. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in clinically recognized pregnancies in the us general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20%. there are no clinical studies of heplisav-b in pregnant women. available human data on heplisav- b administered to pregnant wo

Stati Uniti - inglese - NLM (National Library of Medicine)

a-s medication solutions - hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug in 0.5 ml - engerix-b® is indicated for immunization against infection caused by all known subtypes of hepatitis b virus. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis b-containing vaccine, or to any component of engerix-b, including yeast, is a contraindication to administration of engerix-b [see description (11)]. pregnancy category c animal reproduction studies have not been conducted with engerix-b. it is also not known whether engerix-b can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. engerix-b should be given to a pregnant woman only if clearly needed. it is not known whether engerix-b is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when engerix-b is administered to a nursing woman. safety and effectiveness of engerix-b have been established in all pediatric age-groups. maternally transferred antibodies do not interfere with the active immune response to the vaccine. [see adver

Malta - inglese - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - hepatitis a, virus, inactivated, elisa - suspension for injection in pre-filled syringe - hepatitis a virus (inactivated) 1440 elisa unit/dose - vaccines

Malta - inglese - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - hepatitis a, virus, inactivated, elisa - suspension for injection in pre-filled syringe - hepatitis a virus (inactivated) 720 elisa unit/dose - vaccines

Unione Europea - inglese - EMA (European Medicines Agency)

vbi vaccines b.v. - hepatitis b surface antigen - hepatitis b - vaccines - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.,

Filippine - inglese - FDA (Food And Drug Administration)

zuellig pharma corp - hepatitis b (recombinant dna) - suspension for injection im - multidose - 20mcg / ml

Israele - inglese - Ministry of Health

glaxo smith kline (israel) ltd - hepatitis a virus antigen, inactivated - suspension for injection - hepatitis a virus antigen, inactivated 1440 e.l.u/ml - hepatitis a, inactivated, whole virus - hepatitis a, inactivated, whole virus - active immunisation against infections caused by hepatitis a virus.the vaccine is particularly indicated for those at increased risk of infection or transmission.

Israele - inglese - Ministry of Health

glaxo smith kline (israel) ltd - hepatitis a virus antigen, inactivated - suspension for injection - hepatitis a virus antigen, inactivated 720 e.l.u / 0.5 ml - hepatitis a, inactivated, whole virus - hepatitis a, inactivated, whole virus - active immunisation against hav infection from 1 year up to and including 15 years of age. the vaccine is particularly indicated for those at increased risk of infection or transmission. it is also indicated for use during outbreaks of hepatitis a infection.