Unió Europea - anglès - 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.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - tetanus protein, quantity: 22 microgram; haemophilus type b polysaccharide, quantity: 12 microgram; pertussis toxoid, quantity: 25 microgram; diphtheria toxoid, quantity: 20 iu; poliovirus, quantity: 8 dagu; poliovirus, quantity: 40 dagu; tetanus toxoid, quantity: 40 iu; pertussis filamentous haemagglutinin, quantity: 25 microgram; poliovirus, quantity: 32 dagu; hepatitis b surface antigen, quantity: 10 microgram - injection, suspension - excipient ingredients: sucrose; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; water for injections; aluminium hydroxide hydrate; trometamol; tyrosine; arginine hydrochloride; histidine; isoleucine; leucine; lysine hydrochloride; phenylalanine; threonine; tryptophan; valine; cystine; methionine - hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive infections caused by haemophilus influenzae type b. use of this vaccine should be in accordance with the national recommendation as per the current immunisation handbook.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - pertussis toxoid, quantity: 16 microgram/ml; pertussis filamentous haemagglutinin, quantity: 16 microgram/ml; pertactin, quantity: 5 microgram/ml; diphtheria toxoid, quantity: 4 iu/ml; tetanus toxoid, quantity: 40 iu/ml - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium phosphate; sodium chloride; water for injections - boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older (see section 4.2 dose and method of administration).,boostrix is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see section 4.2 dose and method of administration, section 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties).,the use of boostrix should be in accordance with official recommendations.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - pertussis toxoid, quantity: 16 microgram/ml; tetanus toxoid, quantity: 40 iu/ml; diphtheria toxoid, quantity: 4 iu/ml; pertactin, quantity: 5 microgram/ml; pertussis filamentous haemagglutinin, quantity: 16 microgram/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; aluminium phosphate; sodium chloride - boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older (see section 4.2 dose and method of administration).,boostrix is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see section 4.2 dose and method of administration, section 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties).,the use of boostrix should be in accordance with official recommendations.

Austràlia - anglès - 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.

Filipines - anglès - FDA (Food And Drug Administration)

n/a; importer: ip biotech, inc.; distributor: ip biotech, inc. - diphtheria, tetanus, pertussis (whole cell), hepatitis b (rdna) and haemophilus influenzae type b conjugate vaccine (adsorbed) - solution for injection (i.m) - each dose (0.5 ml) contains: diphtheria toxoid ................... 25 lf ( > 30 iu) tetanus toxoid ...................... 5.5 lf (> 60 iu) b. pertussis (whole cell) ........... 16 iou ( >4 iu) hepatitis b (rdna) ................ 12.5 ug purified capsular polysaccharide (prp) of hib covalently linked to 20 to 36.7 ug of tetanus toxoid .... ............... 11 ug alt+t (as alpo4) ........ ............. <1.25 mg thiomersal ............ ........... 0.01% w/v

Filipines - anglès - FDA (Food And Drug Administration)

n/a; importer: ip biotech, inc.; distributor: ip biotech, inc. - diphtheria, tetanus, pertussis (whole cell), hepatitis b (rdna) and haemophilus influenzae type b conjugate vaccine (adsorbed) - suspension for injection (im) - each dose (0.5 ml) contains: diphtheria toxoid 25 lf 30 iu) tetanus toxoid....................... 5.5 lf 60 iu) b. pertussis (whole cell ............ 16 iou ( 4 iu) hepatitis b (rdna)................12.5 ug purified capsular polysaccharide (prp) of hib covalently linked to 20 to 36.7 ug of tetanus toxoid ..................11 ug alt++ (as alpo4)..................... 51.25 mg thiomersal .......... 0.01% w/v

Filipines - anglès - FDA (Food And Drug Administration)

n/a; importer: sanofi pasteur, inc.; distributor: sanofi pasteur, inc. - diphtheria, tetanus, pertussis (whole cell), hepatitis b (idna) and haemophilus influenzae type b conjugate vaccine (adsorbed) - suspension for injection (im) - formulation: each dose (0.5 ml) contains: diphtheria toxoid-> 30 iu tetanus toxoid- > 60 iu bordetella pertussis (whole cell)-> 4u hepatitis b (r-dna) surface antigen-10 ug purified capsular polysaccharide of hib conjugated to 20-40 mcg tetanus toxoid (carrier protein)-10 ug

Namíbia - anglès - Namibia Medicines Regulatory Council

serum institute of india ltd - diphtheria, tetanus, ; pertussis, hepatitis b; haemophilus influenzae type b conjugate - injection - each dose of 0.5 ml contains diphtheria ; toxoid ? 30 iu, tetanus toxoid ? 40 iu, ; haemophilus influenzae type b.pertussis

Malta - anglès - Medicines Authority

bilthoven biologicals b.v. antonie van leeuwenhoeklaan 9 3721 ma, bilthoven, netherlands - suspension for injection - diphtheria toxoid >5 iu poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 4 dagu poliovirus (inactivated) type 3 (saukett strain) 7.5 dagu tetanus toxoid >20 iu - vaccines