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

sanofi-aventis australia pty ltd - poliovirus, quantity: 26 dagu; poliovirus, quantity: 7 dagu; pertactin, quantity: 3 microgram; tetanus toxoid, quantity: 20 iu; diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 5 microgram; pertussis fimbriae 2 + 3, quantity: 5 microgram; poliovirus, quantity: 29 dagu - injection, suspension - excipient ingredients: aluminium phosphate; formaldehyde; polysorbate 80; neomycin; water for injections; phenoxyethanol; streptomycin sulfate; polymyxin b sulfate; glutaral; ethanol - adacel polio is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation.,children 4-6 years of age should have already received four doses of dtpa and ipv or opv.,adacel polio is not intended for primary immunisation.,adacel polio may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.,the use of adacel polio should be determined on the basis of official recommendations. for further information, refer to the current immunisation handbook.

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

sanofi-aventis australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis filamentous haemagglutinin, quantity: 5 microgram; pertussis toxoid, quantity: 2.5 microgram; pertussis fimbriae 2 + 3, quantity: 5 microgram; pertactin, quantity: 3 microgram; tetanus toxoid, quantity: 20 iu - injection, suspension - excipient ingredients: glutaral; formaldehyde; phenoxyethanol; water for injections; aluminium phosphate - adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu]; pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid, adsorbed 40 [iu]; diphtheria toxoid, adsorbed 30 [iu]; pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid, adsorbed 40 [iu] - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid, adsorbed 40 [iu] excipient: aluminium as aluminium hydroxide & phosphate sodium chloride water for injection active: diphtheria toxoid, adsorbed 30 [iu] pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid, adsorbed 40 [iu] excipient: aluminium as aluminium hydroxide & phosphate phenoxyethanol polysorbate 80 sodium chloride water for injection - infanrix (dtpa) is indicated for active primary immunisation against diptheria, tetanus and pertussis. infanrix is indicated as fourth and/or fifth dose for children from 15 months of age up to and including 6 years of age who have previously been immunised with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 60 iu/ml; pertactin 16 µg/ml; pertussis filamentous haemagglutinin 50 µg/ml; pertussis toxoid, adsorbed 50 µg/ml; polio virus type 1 80 dagu/ml; polio virus type 2 16 dagu/ml; polio virus type 3 64 dagu/ml; tetanus toxoid, adsorbed 80 iu/ml - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 60 iu/ml pertactin 16 µg/ml pertussis filamentous haemagglutinin 50 µg/ml pertussis toxoid, adsorbed 50 µg/ml polio virus type 1 80 dagu/ml polio virus type 2 16 dagu/ml polio virus type 3 64 dagu/ml tetanus toxoid, adsorbed 80 iu/ml excipient: aluminium hydroxide neomycin sulfate polymyxin b sulfate sodium chloride water for injection - infanrix®-ipv is indicated for active primary immunisation against diphtheria, tetanus, pertussis, and poliomyelitis. infanrix®-ipv is also indicated as a booster dose for children who have previously been immunised with dtp and polio antigens.

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

sanofi-aventis australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis filamentous haemagglutinin, quantity: 5 microgram; pertussis toxoid, quantity: 2.5 microgram; pertussis fimbriae 2 + 3, quantity: 5 microgram; pertactin, quantity: 3 microgram; tetanus toxoid, quantity: 20 iu - injection, suspension - excipient ingredients: glutaral; formaldehyde; phenoxyethanol; water for injections; aluminium phosphate - adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

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

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

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

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; tetanus toxoid, quantity: 20 lfu/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 2 [iu] ((2 lfu)); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 2.5ug; tetanus toxoid 20 [iu] ((5 lfu)) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] ((2 lfu)) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 2.5ug tetanus toxoid 20 [iu] ((5 lfu)) excipient: aluminium phosphate phenoxyethanol water for injection - adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 2 [iu] (nlt, equiv to 2 lf per dose); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 2.5ug; polio virus type 1 29 dagu (mahoney, by parallel line method (equiv to 40 dagu by sigmoid method)); polio virus type 2 7 dagu (mef 1, by parallel line method (equiv to 8 dagu by sigmoid method)); polio virus type 3 26 dagu (saukett, by parallel line method (equiv to 32 dagu by sigmoid method)); tetanus toxoid 20 [iu] (nlt, equiv to 5 lf per dose) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] (nlt, equiv to 2 lf per dose) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 2.5ug polio virus type 1 29 dagu (mahoney, by parallel line method (equiv to 40 dagu by sigmoid method)) polio virus type 2 7 dagu (mef 1, by parallel line method (equiv to 8 dagu by sigmoid method)) polio virus type 3 26 dagu (saukett, by parallel line method (equiv to 32 dagu by sigmoid method)) tetanus toxoid 20 [iu] (nlt, equiv to 5 lf per dose) excipient: aluminium phosphate ethanol phenoxyethanol polysorbate 80 water for injection - adacel® polio is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation. children 4-6 years of age should have already received four doses of dtpa and ipv or opv. adacel® polio is not intended for primary immunisation. adacel® polio may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus. the use of adacel® polio should be determined on the basis of official recommendations.

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.