Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - hepatitis b, recombinant surface antigen - hepatitis b; immunization - vaccines - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. the specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis-b infection. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. the specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis-b infection. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. it can be expected that hepatitis d will also be prevented by immunisation with hbvaxpro as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.,

Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaccines - twinrix adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis a and hepatitis b infection.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

dispensing solutions, inc. - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 1440 [iu] in 1 ml - havrix® is indicated for active immunization against disease caused by hepatitis a virus (hav). havrix is approved for use in persons 12 months of age and older. primary immunization should be administered at least 2 weeks prior to expected exposure to hav. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing vaccine, or to any component of havrix, including neomycin, is a contraindication to administration of havrix [see description (11)] . pregnancy category c animal reproduction studies have not been conducted with havrix. it is also not known whether havrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. havrix should be given to a pregnant woman only if clearly needed. it is not known whether havrix is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when havrix is administered to a nursing woman. the safety and effectiveness of havrix, doses of 360 el.u. or 720 e

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

dispensing solutions, inc. - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 1440 [iu] in 1 ml - havrix® is indicated for active immunization against disease caused by hepatitis a virus (hav). havrix is approved for use in persons 12 months of age and older. primary immunization should be administered at least 2 weeks prior to expected exposure to hav. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing vaccine, or to any component of havrix, including neomycin, is a contraindication to administration of havrix [see description (11)] . pregnancy category c animal reproduction studies have not been conducted with havrix. it is also not known whether havrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. havrix should be given to a pregnant woman only if clearly needed. it is not known whether havrix is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when havrix is administered to a nursing woman. the safety and effectiveness of havrix, doses of 360 el.u. or 720 e

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

merck sharp & dohme llc - hepatitis a virus strain cr 326f antigen (formaldehyde inactivated) (unii: q04q922k9q) (hepatitis a virus strain cr 326f antigen (formaldehyde inactivated) - unii:q04q922k9q) - hepatitis a virus strain cr 326f antigen (formaldehyde inactivated) 25 [iu] in 0.5 ml - vaqta® [hepatitis a vaccine, inactivated] is indicated for the prevention of disease caused by hepatitis a virus (hav) in persons 12 months of age and older. the primary dose should be given at least 2 weeks prior to expected exposure to hav. do not administer vaqta to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis a vaccine, or to individuals who have had an anaphylactic reaction to any component of vaqta, including neomycin [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. 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 vaqta in pregnant women. available post-approval data do not suggest an increased risk of miscarriage or major birth def

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 720 [iu] in 0.5 ml - havrix is indicated for active immunization against disease caused by hepatitis a virus (hav). havrix is approved for use in persons 12 months of age and older. primary immunization should be administered at least 2 weeks prior to expected exposure to hav. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing vaccine, or to any component of havrix, including neomycin, is a contraindication to administration of havrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. 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 of havrix in pregnant women in the u.s. available data do not suggest an increased risk of major birth defects and miscarriage in women who received havrix during pregnancy (see data) . there are no animal studies with havrix to inform use during pregnancy. data human data: in pre- and post-licensure clinical studies of havrix, 175 pregnant women (177 outcomes, including two sets of twins) were inadvertently administered havrix following their last menstrual period. after excluding ectopic pregnancies (n = 2), molar pregnancies (n = 1), elective terminations (n = 22, including one of a fetus with a birth defect), those that were lost to follow-up (n = 9), and those with an unknown exposure timing (n = 5), there were 138 known pregnancy outcomes with exposure during the first or second trimester. of these, miscarriage was reported in 11% of pregnancies exposed prior to 20 weeks gestation (15/136) and major birth defects were reported in 3.3% (4/123) of live births. the rates of miscarriage and major birth defects were consistent with estimated background rates. risk summary there is no information regarding the presence of havrix in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for havrix and any potential adverse effects on the breastfed child from havrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. the safety and effectiveness of havrix, doses of 360 el.u. or 720 el.u., have been evaluated in more than 22,000 subjects aged 1 to 18 years. the safety and effectiveness of havrix have not been established in subjects younger than 12 months. clinical studies of havrix did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects. subjects with chronic liver disease had a lower antibody response to havrix than healthy subjects [see clinical studies (14.3)] .

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine - 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 (< 10 iu/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.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - hepatitis b immunoglobulin, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine - 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 (< 10 iu/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.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

a-s medication solutions - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 1440 [iu] in 1 ml - havrix is indicated for active immunization against disease caused by hepatitis a virus (hav). havrix is approved for use in persons 12 months of age and older. primary immunization should be administered at least 2 weeks prior to expected exposure to hav. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing vaccine, or to any component of havrix, including neomycin, is a contraindication to administration of havrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. 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 of havrix in pregnant women in the u.s. available data do not suggest an increased risk of major birth defects and miscarriage in women who received havrix during pregnancy (see data) . there are no animal studies with havrix to inform use during pregnancy. data human data: in pre- and post-licensure clinical studies of havrix, 175 pregnant women (177 outcomes, including two sets of twins) were inadvertently administered havrix following their last menstrual period. after excluding ectopic pregnancies (n = 2), molar pregnancies (n = 1), elective terminations (n = 22, including one of a fetus with a birth defect), those that were lost to follow-up (n = 9), and those with an unknown exposure timing (n = 5), there were 138 known pregnancy outcomes with exposure during the first or second trimester. of these, miscarriage was reported in 11% of pregnancies exposed prior to 20 weeks gestation (15/136) and major birth defects were reported in 3.3% (4/123) of live births. the rates of miscarriage and major birth defects were consistent with estimated background rates. risk summary there is no information regarding the presence of havrix in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for havrix and any potential adverse effects on the breastfed child from havrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. the safety and effectiveness of havrix, doses of 360 el.u. or 720 el.u., have been evaluated in more than 22,000 subjects aged 1 to 18 years. the safety and effectiveness of havrix have not been established in subjects younger than 12 months. clinical studies of havrix did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects. subjects with chronic liver disease had a lower antibody response to havrix than healthy subjects [see clinical studies (14.3)] .

Եվրոպական Միություն - անգլերեն - EMA (European Medicines Agency)

dynavax gmbh - hepatitis b surface antigen - hepatitis b - vaccines - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations.it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.