Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram/ml - injection, suspension - excipient ingredients: borax; sodium chloride; aluminium; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 40 microgram/ml - injection, suspension - excipient ingredients: borax; sodium chloride; aluminium; water for injections - h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who ar at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hepatitis b surface antigen recombinant, quantity: 5 microgram - injection, suspension - excipient ingredients: aluminium; water for injections; sodium chloride; borax - for use in the immunisation against infection caused by all known subtypes of hepatitis b virus. indications as at 17 november 2000: h-b-vax ii is indicated for immunisation against infection caused by all known subtypes of hepatitis b virus. adolescent vaccination is not necessary for children who have received a primary course of hepatitis b vaccine. vaccination is recommended in adults who are at substantial risk of hepatitis b virus infection and have demonstrated or judged to be susceptible. vaccination of individuals who have antibodies against hepatitis b virus from a previous infection is not necessary.

Australia - English - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; hepatitis b immunoglobulin, quantity: 100 iu - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 8 august 2002 : hepatitis b immunoglobulin is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive material or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin is also indicated for prophylaxis in infants born to hbsag-positive mothers. hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

United States - English - NLM (National Library of Medicine)

dispensing solutions inc. - 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 20 ug in 1 ml - engerix-b is indicated for immunization against infection caused by all known subtypes of hepatitis b virus. as hepatitis d (caused by the delta virus) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by engerix-b vaccination. engerix-b will not prevent hepatitis caused by other agents, such as hepatitis a, c, and e viruses, or other pathogens known to infect the liver. immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to hepatitis b virus,1 for example: - infants, including those born of hbsag-positive mothers (see dosage and administration.) - adolescents (see clinical pharmacology.) - healthcare personnel: dentists and oral surgeons. dental, medical, and nursing students. physicians, surgeons, and podiatrists. nurses. paramedical and ambulance personnel and custodial staff who may be exposed to the virus via blood or other patient specimens. dental hygienists and dental n

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - 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 5 ug in 0.5 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

United States - English - 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

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - purified hepatitis b antigen - suspension for injection - purified hepatitis b antigen 20 mcg / 1 ml - hepatitis b, purified antigen - hepatitis b, purified antigen - engerix b is indicated for active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes in non immune subjects .. the 20 µg dose vaccine in 1.0 ml suspension is intended for use in subjects 16 years of age and above. the 10 µg dose vaccine in 0.5 ml suspension is intended for use in subjects up to and including 15 years of age, including neonates. the categories within the population to be immunised are determined on the basis of official recommendations.it can be expected that hepatitis d will also be prevented by immunisation with engerix b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - purified hepatitis b antigen - suspension for injection - purified hepatitis b antigen 10 mcg / 0.5 ml - hepatitis b, purified antigen - hepatitis b, purified antigen - engerix b is indicated for active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes in non immune subjects . the 20 µg dose vaccine in 1.0 ml suspension is intended for use in subjects 16 years of age and above. the 10 µg dose vaccine in 0.5 ml suspension is intended for use in subjects up to and including 15 years of age, including neonates. the categories within the population to be immunised are determined on the basis of official recommendations.it can be expected that hepatitis d will also be prevented by immunisation with engerix b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - hepatitis b surface antigen, recominant - suspension for injection in pre-filled syringe - 10/0.5 microgram(s)/millilitre - hepatitis vaccines; hepatitis b, purified antigen