Nový Zéland - angličtina - 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.

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

zoetis ireland limited - parainfluenza 3 virus, modified live, strain rlb103, bovine respiratory syncytial virus, modified live, strain 375, inactivated bovine viral diarrhoea virus 1, strain 5960 (cytopathic), inactivated bovine viral diarrhoea virus type 1 strain 6309 (non cytopathic), inactivated bovine viral diarrhoea virus (bvdv) type 1, strain 5960 (cytopathic) induce a gmt2 in guinea pigs - lyophilisate for suspension for injection - unknown - live and inactivated viral vaccines - bovine - immunological - mixed vaccine (live and inactivated)

Evropská unie - angličtina - EMA (European Medicines Agency)

bavarian nordic a/s - modified vaccinia ankara - bavarian nordic (mva-bn) virus - smallpox vaccine; monkeypox virus - other viral vaccines, - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4.4 and 5.1).the use of this vaccine should be in accordance with official recommendations.

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

zoetis ireland limited - parainfluenza 3 virus, modified live, strain rlb103, bovine respiratory syncytial virus, modified live, strain 375, inactivated bovine viral diarrhoea virus 1, strain 5960 (cytopathic), inactivated bovine viral diarrhoea virus type 1 strain 6309 (non cytopathic), inactivated bovine viral diarrhoea virus (bvdv) type 1, strain 5960 (cytopathic) induce a gmt2 in guinea pigs - lyophilisate for suspension for injection - live and inactivated viral vaccines - bovine - immunological - mixed vaccine (live and inactivated)

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 720 elisa unit - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium; polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; 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 - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts o

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 1440 elisa unit - injection, suspension - excipient ingredients: polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; aluminium hydroxide hydrate; 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 - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts o

Austrálie - angličtina - 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - coxiella burnetii, quantity: 5 microgram/ml - injection - excipient ingredients: sodium chloride; monobasic sodium phosphate dihydrate; thiomersal; water for injections; dibasic sodium phosphate dodecahydrate - q-vax is indicated for the immunisation of susceptible adults at identifiable risk of infection with q fever. abattoir workers (and those closely associated with the meat industry), farmers, veterinarians, stockyard workers, shearers, animal transporters and many others exposed to cattle, sheep or goats or their products should be considered for vaccination. note: q fever has also occurred among persons culling and processing kangaroos and laboratory personnel handling potentially infected veterinary specimens, or visiting abattoirs, are at risk.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

moderna australia pty ltd - elasomeran, quantity: 0.2 mg/ml - injection, suspension - excipient ingredients: heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; trometamol hydrochloride; trometamol; water for injections; cholesterol; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000; sodium acetate trihydrate; sucrose; distearoylphosphatidylcholine; glacial acetic acid - spikevax (elasomeran) covid-19 vaccine has provisional approval for the indication below:,active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 years of age and older.,the use of this vaccine should be in accordance with official recommendations.,the decision has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment. active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 years of age and older. the use of this vaccine should be in accordance with official recommendations.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

moderna australia pty ltd - elasomeran, quantity: 0.1 mg/ml - injection, suspension - excipient ingredients: cholesterol; distearoylphosphatidylcholine; trometamol; trometamol hydrochloride; glacial acetic acid; sodium acetate trihydrate; sucrose; water for injections; heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate; 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 - spikevax (elasomeran) covid-19 vaccine has provisional approval for the indication below:,active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 years of age and older.,the use of this vaccine should be in accordance with official recommendations.,the decision has been made on the basis of short-term efficacy and safety data. continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and postmarket assessment spikevax (elasomeran) covid-19 vaccine is indicated for: active immunisation to prevent coronavirus disease 2019 (covid-19) caused by sars-cov-2 in individuals 6 years of age and older. the use of this vaccine should be in accordance with official recommendations.