Malta - English - Medicines Authority

smithkline beecham limited - pertactin; pertussis filamentous haemagglutinin; pertussis toxoid; poliovirus (inactivated) type 1 (mahoney strain); poliovirus (inactivated) type 2 (mef-1 strain); poliovirus (inactivated) type 3 (saukett strain); diphtheria toxoid; haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate); tetanus toxoid - powder and suspension for suspension for injection - pertactin 8 µg; pertussis filamentous haemagglutinin 25 µg; pertussis toxoid 25 µg; poliovirus (inactivated) type 1 (mahoney strain) 40 dagu/0.5ml; poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu/0.5ml; poliovirus (inactivated) type 3 (saukett strain) 32 dagu/0.5ml; diphtheria toxoid; haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg; tetanus toxoid - vaccines

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.

Australia - English - 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.

Australia - English - 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.

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.

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - (acellular pertussis) filamentous haemagglutinin adsorbed (fha); (acellular pertussis) fimbriae type 2 and 3 adsorbed (fim); (acellular pertussis) pertactin adsorbed (prn); (acelullar pertussis) pertussis toxoid adsorbed (pt); diphtheria toxoid adsorbed; tetanus toxoid adsorbed - injection, suspension - 5 micrograms - (acellular pertussis) filamentous haemagglutinin adsorbed (fha) 5 micrograms; (acellular pertussis) fimbriae type 2 and 3 adsorbed (fim) 5 micrograms; (acellular pertussis) pertactin adsorbed (prn) 3 micrograms; (acelullar pertussis) pertussis toxoid adsorbed (pt) 2.5 micrograms; diphtheria toxoid adsorbed 2 lf; tetanus toxoid adsorbed 5 lf

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection - diphtheria toxoid filamentous haemagglutinin (fha) 8 µg pertactin 2.5 µg pertussis toxoid 8 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu tetanus toxoid - vaccines

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis toxoid, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection in pre-filled syringe - diphtheria toxoid filamentous haemagglutinin (fha) 8 µg tetanus toxoid pertussis toxoid 8 µg pertactin 2.5 µg - vaccines

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis toxoid, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection - pertactin 2.5 µg pertussis toxoid 8 µg diphtheria toxoid filamentous haemagglutinin (fha) 8 µg tetanus toxoid - vaccines

Malta - English - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection in pre-filled syringe - pertactin 8 µg pertussis toxoid 25 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu diphtheria toxoid filamentous haemagglutinin (fha) 25 µg tetanus toxoid - vaccines