Jungtinės Valstijos - anglų - 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

Jungtinės Valstijos - anglų - 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

Jungtinės Valstijos - anglų - 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

Australija - anglų - Department of Health (Therapeutic Goods Administration)

abbott australasia pty ltd diagnostic division - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - this assay is a two-step immunoassay for the quantitative determination of anti-hbs in human serum and plasma using chemiluminescent microparticle immunoassay (cmia) technology. the alinity i anti-hbs assay is a chemiluminescent microparticle immunoassay (cmia) used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in human serum and plasma on the alinity i analyzer.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

diasorin australia pty ltd - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - the liaison? xl murex anti-hbs assay uses chemiluminescence immunoassay (clia) technology for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in human serum or plasma samples. the test has to be performed on the liaison? analyzer family. ivds for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs).

Australija - anglų - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay ?eclia? intended for use for use on the cobas e immunoassay analyzers for the in vitro quantitative determination of human antibodies to the hepatitis b surface antigen (hbsag). immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma, for diagnostic use and testing of blood donations.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay "eclia" intended for use on the cobas e immunoassay analyzers. immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis b surface antigen (hbsag) in human serum and plasma, for diagnostic use and testing of blood donations.

Malta - anglų - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - hepatitis b, surface antigen, recombinant - suspension for injection in pre-filled syringe - hepatitis b surface antigen, recombinant 10 µg - vaccines

Malta - anglų - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - hepatitis b, surface antigen, recombinant - suspension for injection in pre-filled syringe - hepatitis b surface antigen, recombinant 20 µg - vaccines

Malta - anglų - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - hepatitis b, surface antigen, recombinant - suspension for injection - hepatitis b surface antigen, recombinant 20 µg/l - vaccines