European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaccines - ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-a and hepatitis-b infection.protection against hepatitis-b infections may not be obtained until after the second dose.therefore:ambirix should be used only when there is a relatively low risk of hepatitis-b infection during the vaccination course;it is recommended that ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.

European Union - English - 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - hepatitis a virus - suspension for injection in pre-filled syringe - 160 d-ant. percent volume/volume - hepatitis vaccines; hepatitis a, inactivated, whole virus

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - vaccines - twinrix paediatric is indicated for use in non-immune infants, children and adolescents from one year up to and including 15 years who are at risk of both hepatitis-a and hepatitis-b infection.

United States - English - 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

United States - English - 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

United States - English - 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)] .

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis a vaccine 1440 eu/ml;  ; hepatitis a vaccine 1440 eu/ml - suspension for injection - 1440 eu/ml - active: hepatitis a vaccine 1440 eu/ml   excipient: aluminium hydroxide amino acids dibasic sodium phosphate dihydrate monobasic potassium phosphate polysorbate 20 potassium chloride sodium chloride active: hepatitis a vaccine 1440 eu/ml excipient: aluminium hydroxide amino acids dibasic sodium phosphate dihydrate monobasic potassium phosphate phenoxyethanol polysorbate 20 potassium chloride sodium chloride - havrix is indicated for active immunisation against hav infection in subjects at risk of exposure to hav. havrix will not prevent hepatitis infection caused by other agents such as hepatitis b virus, hepatitis c virus, hepatitis e virus or other pathogens known to infect the liver. in areas of low and intermediate prevalence of hepatitis a, immunisation with havrix is particularly recommended in subjects who are, or will be, at increased risk of infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis b vaccine, rdna 10 µg/ml - suspension for injection - 10 mcg/ml - active: hepatitis b vaccine, rdna 10 µg/ml excipient: aluminium as amorphous aluminum hydroxyphosphate sulphate borax formaldehyde potassium thiocyanate sodium chloride water for injection - immunisation against infection caused by all known subtypes of hepatitis b virus. hbvaxpro should also prevent hepatitis d (caused by the delta virus) since hepatitis d does not occur in the absence of hepatitis b infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis b vaccine, rdna 40 µg/ml - suspension for injection - 40 mcg/ml - active: hepatitis b vaccine, rdna 40 µg/ml excipient: aluminium as amorphous aluminum hydroxyphosphate sulphate borax formaldehyde potassium thiocyanate sodium chloride water for injection - immunisation against infection caused by all known subtypes of hepatitis b virus. hbvaxpro should also prevent hepatitis d (caused by the delta virus) since hepatitis d does not occur in the absence of hepatitis b infection.