Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - strain cr 326f hepatitis a virus, inactivated 50 u - suspension for injection in pre-filled syringe - 50 u/1 millilitre(s) - hepatitis vaccines; hepatitis a, inactivated, whole virus

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - aluminium; hepatitis a antigen - suspension for injection in pre-filled syringe - 720 enzyme-linked immunosorbent assay unit - hepatitis vaccines; hepatitis a, inactivated, whole virus

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - aluminium; hepatitis a antigen - suspension for injection in pre-filled syringe - 1440 enzyme-linked immunosorbent assay unit - hepatitis vaccines; hepatitis a, inactivated, whole virus

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; hepatitis a virus antigen, quantity: 720 elisa unit/ml - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium phosphate; polysorbate 20; water for injections; neomycin sulfate; monobasic sodium phosphate; trometamol; sodium chloride; dibasic sodium phosphate heptahydrate; formaldehyde solution; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years. twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; hepatitis a virus antigen, quantity: 720 elisa unit/ml - injection, suspension - excipient ingredients: trometamol; aluminium hydroxide hydrate; sodium chloride; polysorbate 20; neomycin sulfate; water for injections; formaldehyde solution; aluminium phosphate; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years. twinrix (720/20) is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults and children from 1 year of age. twinrix junior (360/10) is indicated for use in children aged 1 to 15 years.

United States - English - 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

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - hepatitis a vaccine 50 u/ml - suspension for injection - 50 u/ml - active: hepatitis a vaccine 50 u/ml excipient: aluminium as amorphous aluminium hydroxyphosphate sulphate borax sodium chloride water for injection - vaqta is indicated for active pre-exposure prophylaxis against disease caused by hepatitis a virus. primary immunisation should be given at least 2 weeks prior to expected exposure to hav. vaccination is recommended in children 12 months of age and older, adolescents, and adults who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected, including but not limited to: · travellers to endemic or outbreak areas · frequently affected communities - members residing in any community with one or more recorded outbreaks within the last five years · daycare - children and staff of daycare centres as well as their parents, siblings, and other contacts · military personnel prior to departure for endemic or outbreak areas · persons for whom hepatitis a is an occupational hazard - health-care workers - staff and residents of orphanages, chronic care hospitals and mental health care facilities - sewage workers · haemophiliacs and other recipients of therapeutic blood products · persons who test positive for hepatitis c virus and have diagnosed liver disease · food handlers · consumers of high-risk foods e.g. raw shellfish · persons at increased risk of the disease due to their sexual practices - homosexually-active males - persons who repeatedly contract sexually transmitted diseases · human immunodeficiency virus (hiv)-infected adults · users of illicit injectable drugs vaqta will not prevent hepatitis caused by infectious agents other than hepatitis a virus.

Malta - English - Medicines Authority

smithkline beecham limited - hepatitis a virus (inactivated) - suspension for injection - hepatitis a virus (inactivated) 1440 elisa unit/dose - vaccines

Malta - English - Medicines Authority

smithkline beecham limited - hepatitis a virus (inactivated) - suspension for injection - hepatitis a virus (inactivated) 720 elisa unit/dose - vaccines

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - hepatitis a virus antigen (inactivated); hepatitis b surface antigen (r-dna) - injection - 720 elisa units/ml - hepatitis a virus antigen (inactivated) 720 elisa units/ml; hepatitis b surface antigen (r-dna) 20 mcg/ml