Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis a vaccine 1440 eu/ml (virus antigen (hm175 strain)); vi capsular polysaccharide of s. typhi ty2 25 µg/ml;   - suspension for injection - active: hepatitis a vaccine 1440 eu/ml (virus antigen (hm175 strain)) vi capsular polysaccharide of s. typhi ty2 25 µg/ml   excipient: aluminium hydroxide amino acids formaldehyde neomycin sulfate polysorbate 20 sodium chloride trometamol water for injection - hepatyrix is indicated for active immunisation of adults and adolescents older than 15 years of age at risk of both hepatitis a virus infection and typhoid fever. immunisation with hepatyrix is particularly recommended in subjects who are, or will be, at increased risk of infection such as travellers from countries of low endemicity to areas where the prevalence of hepatitis a and typhoid fever is high.

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: monobasic sodium phosphate; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 10 microgram - injection, suspension - excipient ingredients: dibasic sodium phosphate dihydrate; aluminium hydroxide hydrate; sodium chloride; monobasic sodium phosphate; water for injections - engerix-b is indicated for active immunisation against hepatitis b virus infection. the nh&mrc* recommend all infants, young children and unvaccinated adolescents receive a primary course of immunisation against hepatitis b. the nh&mrc also recommends immunisation for persons who are at substantial risk and have been demonstrated or judged to be susceptible to the hepatitis b virus. groups identified at increased risk of acquiring hbv infection include: infants born to carrier (hbsag-positive) mothers; individuals for whom post-exposure prophylaxis for hepatitis b is indicated; household contacts (other than sexual partners) of acute and chronic hepatitis b cases and carriers; susceptible sexual contacts. risk occurs in susceptible (anti-hbs negative) partners of hbv carriers and patients with acute hepatitis b; susceptible clients of std (sexually transmitted disease) clinics, and sexually active men who have sex with men are also at increased risk of infection; injecting drug users; haemodialysis patients, hiv-positive individuals and other immunosuppressed adults; patients receiving certain blood products especially patients with clotting disorders receiving blood product concentrates; individuals with chronic liver disease and / or hepatitis c; staff and residents of facilities for the intellectually disabled, including both residential and non-residential care of this group; liver transplant recipients. such individuals should be vaccinated prior to transplantation if seronegative for hepatitis b, as they may be at increased risk of infection from the transplanted organ; staff and inmates of long term correctional facilities; health care workers, dentists, embalmers, tattooists and body-piercers. all staff directly involved in patient care, embalming, or in the handling of human blood or tissue should be vaccinated; individuals adopting children from overseas. these children should be tested for hepatitis b, and if hbsag positive, members of the adoptive family should be vaccinated; others in whom vaccination may be justified include police, members of the armed forces and emergency services staff, depending on the risks of exposure associated with assigned duties. long term travellers to regions of high endemicity, and those residing for some time in such regions who may anticipate close personal contact with local residents, should be vaccinated. short-term tourists or business travellers are at very little risk of hepatitis b, provided they avoid exposure through sexual contact, injecting drug use, tattooing or body piercing. although the risk of hepatitis b infection in contact sports is low, immunisation of those involved should not be discouraged. as the risk in australian schools is very low, vaccination of classroom contacts is seldom indicated. nevertheless, vaccination of school children and adolescents should be encouraged; as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection, it can be expected that hepatitis d will also be prevented by vaccination with engerix-b. the vaccine will not protect against infection caused by hepatitis a, hepatitis c and hepatitis e viruses, and other pathogens known to infect the liver.

Bangladesh - englanti - DGDA (Directorate General of Drug Administration)

incepta pharmaceuticals ltd., vaccine division - hepatitis b vaccine - vaccine - 20 mcg/ml

Bangladesh - englanti - DGDA (Directorate General of Drug Administration)

incepta pharmaceuticals ltd., vaccine division - hepatitis b vaccine - vaccine - 10 mcg/ml

Yhdysvallat - englanti - 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

Yhdysvallat - englanti - 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

Yhdysvallat - englanti - 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

Yhdysvallat - englanti - 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)] .

Irlanti - englanti - 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