Belgium - Dutch - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals - hepatitis a-virus (hav) antigeen - suspensie voor injectie - hepatitis a-virus (hav) antigeen 1440 elisa e - 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

European Union - Slovenian - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis b surface antigen, poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - cepiva - infanrix hexa je indicirano za osnovno in obnovitveno cepljenje dojenčkov proti davici, tetanus, oslovski kašelj, hepatitis b, otroški ohromelosti in bolezen, ki povzroča haemophilus influenzae tipa b.

European Union - Slovenian - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - cepiva - twinrix pediatric je indiciran za uporabo pri neimunskih dojenčkih, otrocih in mladostnikih od enega leta do vključno 15 let, pri katerih obstaja tveganje za okužbo s hepatitisom a in hepatitisom b.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml ((>= 98% )as human plasma proteins (exnz)) - solution for injection - 100 iu - active: hepatitis b immunoglobulin, human 160 mg/ml ((>= 98% )as human plasma proteins (exnz)) excipient: glycine water for injection - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) - solution for injection - 400 iu - active: hepatitis b immunoglobulin, human 160 mg/ml (( >= 98%) as human plasma proteins (ex nz)) excipient: glycine water for injection - 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.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur msd, snc - purified diphtheria toxoid, purified tetanus toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis b surface antigen, inactivated type 1 poliovirus (mahoney), inactivated type 2 poliovirus (mef 1), inactivated type 3 poliovirus (saukett), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - this combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis b caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by haemophilus influenzae type b.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, inactivated bordetella pertussis, hepatitis b surface antigen (rdna), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; diphtheria - vaccines - quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis b and invasive disease caused by haemophilus influenzae type b and for booster immunisation of young children during the second year of life.the use of quintanrix should be determined on the basis of official recommendations.

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; hepatitis b immunoglobulin, quantity: 100 iu - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 8 august 2002 : hepatitis b immunoglobulin 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 (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive material or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin is also indicated for prophylaxis in infants born to hbsag-positive mothers. 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 (<10iu/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.