Uniunea Europeană - engleză - 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 - vaccines - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenzae type-b.

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

sanofi-aventis australia pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; water for injections; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate - vaxigrip tetra is indicated for the prevention of influenza disease caused by the two influenza a virus subtypes and the two influenza b virus types contained in the vaccine for:,- active immunisation of adults, including pregnant women, and children from 6 months of age and older,- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see sections 4.2 dose and method of administration, 4.4 special warnings and precautions for use, 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties ? clinical trials).

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

sanofi-aventis australia pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; water for injections; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate - vaxigrip tetra is indicated for the prevention of influenza disease caused by the two influenza a virus subtypes and the two influenza b virus types contained in the vaccine for:,- active immunisation of adults, including pregnant women, and children from 6 months of age and older,- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see sections 4.2 dose and method of administration, 4.4 special warnings and precautions for use, 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties ? clinical trials).

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

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin; pertactin; pertussis toxoid; tetanus toxoid; poliovirus; diphtheria toxoid -

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu] (not less than); pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; polio virus type 1 40 dagu (inactivated); polio virus type 2 8 dagu (inactivated); polio virus type 3 32 dagu (inactivated); tetanus toxoid, adsorbed 40 [iu] (not less than); haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (20 - 40 mcg of tetanus toxoid per dose) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] (not less than) pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug polio virus type 1 40 dagu (inactivated) polio virus type 2 8 dagu (inactivated) polio virus type 3 32 dagu (inactivated) tetanus toxoid, adsorbed 40 [iu] (not less than) excipient: aluminium lactose medium 199 sodium chloride water for injection active: haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (20 - 40 mcg of tetanus toxoid per dose) - infanrix??-ipv+hib is indicated as a booster dose for children aged 15 months and older who have previously been immunised with dtp, polio and hib antigens. the hib component of the vaccine does not protect against diseases due to other serotypes of haemophilus influenzae nor against meningitis caused by other organisms.

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu]; hepatitis b surface antigen, recombinant 10ug; pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; polio virus type 1 40 dagu (/dose); polio virus type 2 8 dagu (/dose); polio virus type 3 32 dagu (/dose); tetanus toxoid, adsorbed 40 [iu] - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] hepatitis b surface antigen, recombinant 10ug pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug polio virus type 1 40 dagu (/dose) polio virus type 2 8 dagu (/dose) polio virus type 3 32 dagu (/dose) tetanus toxoid, adsorbed 40 [iu] excipient: aluminium hydroxide aluminium phosphate formaldehyde glycine medium 199 monobasic potassium phosphate neomycin sulfate polymyxin b sulfate polysorbate 20 potassium chloride sodium chloride sodium phosphate (32p) water for injection - infanrix®-penta is indicated for immunisation against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis in infants from the age of 6 weeks and may also be given to infants who received a first dose of hepatitis b vaccine at birth.

Israel - engleză - Ministry of Health

sanofi israel ltd - diphtheria toxoid; filamentous haemagglutinin (fha); fimbrae tupes 2 + 3 (fim); inactivated polio virus (ipv) type 1; inactivated polio virus (ipv) type 2; inactivated polio virus (ipv) type 3; pertactin (prn); pertussis toxoid vaccine; tetanus toxoid - suspension for injection - fimbrae tupes 2 + 3 (fim) 5 mcg/dose; pertussis toxoid vaccine 2.5 mcg/dose; filamentous haemagglutinin (fha) 5 mcg/dose; pertactin (prn) 3 mcg/dose; diphtheria toxoid 2 lf / 1 doses; tetanus toxoid 5 lf / 1 doses; inactivated polio virus (ipv) type 1 40 du/dose; inactivated polio virus (ipv) type 2 8 du/dose; inactivated polio virus (ipv) type 3 32 du/dose - diphtheria-pertussis-poliomyelitis-tetanus - diphtheria-pertussis-poliomyelitis-tetanus - active immunization against diphtheria, tetanus, pertussis and poliomyelitis in subjects aged 4 years and over as a booster following primary immunisation.adacel polio is not indicated for primary immunisation. adacel polio is not indicated for treating diseases caused by b.pertussis, c.diphtheriae or c.tetani or by poliomyelitis infections

Singapore - engleză - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid; filamentous haemagglutinin; pertactin; pertussis toxoid; tetanus toxoid - injection - 2 iu/0.5 ml - diphtheria toxoid 2 iu/0.5 ml; filamentous haemagglutinin 8 mcg/0.5 ml; pertactin 2.5 mcg/0.5 ml; pertussis toxoid 8 mcg/0.5 ml; tetanus toxoid 20 iu/0.5 ml

Uniunea Europeană - engleză - EMA (European Medicines Agency)

sanofi pasteur europe - filamentous haemagglutinin, haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate), hepatitis b surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (mahoney strain) produced on vero cells, poliovirus (inactivated) type 2 (mef-1 strain) produced on vero cells, poliovirus (inactivated) type 3 (saukett strain) produced on vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, diphtheria toxoid - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - hexyon (dtap-ipv-hb-hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib).the use of this vaccine should be in accordance with official recommendations.

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

glaxosmithkline australia pty ltd - neisseria meningitidis group b neisseria heparin binding antigen fusion protein, quantity: 50 microgram; neisseria meningitidis serogroup b outer membrane vesicles, quantity: 25 microgram; neisseria meningitidis group b factor h binding protein fusion protein, quantity: 50 microgram; neisseria meningitidis group b neisseria adhesin a protein, quantity: 50 microgram - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; histidine; sodium chloride; sucrose - bexsero is indicated for active immunisation against invasive disease caused by n. meningitidis group b strains. for information on protection against specific group b strains see section 5.1 pharmacodynamic properties. bexsero is indicated for vaccination of individuals from 2 months of age and older.