Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - pertussis toxoid filamentous haemagglutinin (fha) pertactin diphtheria toxoid tetanus toxoid haemophilus influenzae type b polysaccharide tetanus toxoid - powder for suspension for injection - %v/v

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - tetanus toxoid diphtheria toxoid pertussis toxoid filamentous haemagglutinin (fha) pertactin polio virus type 1 inactivated polio virus type 2 inactivated polio virus type 3 inactivated adsorbed fimbriae types 2 + 3 - suspension for injection - %v/v

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glaxosmithkline pharmaceutical sdn. bhd. - diphtheria toxoid; tetanus toxoid; pertussis toxoid (pt); inactivated polio virus type 3; inactivated polio virus type 2; inactivated polio virus type 1; filamentous haemagglutinin (fha); pertactin (prn) -

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,pertactin,pertussis filamentous haemagglutinin,pertussis fimbriae 2 + 3,pertussis toxoid,poliovirus,tetanus toxoid -

Malta - English - Medicines Authority

nm pharma limited 3/4, cantrija complex triq it-targa, il-maghtab naxxar nxr 6613 , malta - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, fha, pertactin, poliovirus, inactivated, type, mahoney strain, mef, saukett strain - suspension for injection in pre-filled syringe - diphtheria toxoid 2 iu poliovirus (inactivated) type 3 (saukett strain) 32 dagu pertactin 2.5 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu tetanus toxoid 20 iu pertussis toxoid 8 µg filamentous haemagglutinin (fha) 8 µg - vaccines

Uganda - English - National Drug Authority

glaxosmithkline ltd belgium - diphtheria toxoid+tetanus toxoid+pertussis toxoid(pt)+filamentous haemagglutinin(fha)+pertactin(69kda omp)+hbsag purified,inactivated polio virus type i+inactivated polio virus type ii+inactivated polio virus type iii+purified capsular polysaccharide of hib covalently bound to tetanus toxoid(prp-t) - parenteral ordinary combination pack vials - min 30 i.u+min 40 i.u+25?g+25?g+8?g+10?g,40du+8du+32du+10?g

Israel - English - Ministry of Health

sanofi israel ltd - diphtheria toxoid; filamentous haemagglutinin (fha); fimbrae tupes 2 + 3 (fim); pertactin (prn); pertussis toxoid vaccine; tetanus toxoid - suspension for injection - tetanus toxoid 5 lf / 1 doses; pertussis toxoid vaccine 2.5 mcg/dose; filamentous haemagglutinin (fha) 5 mcg/dose; fimbrae tupes 2 + 3 (fim) 5 mcg/dose; pertactin (prn) 3 mcg/dose; diphtheria toxoid 2 lf / 1 doses - diphtheria-pertussis-poliomyelitis-tetanus - active booster immunization against diphtheria, tetanus and pertussis in children, adolescents and adults aged 4 to 64 years. adacel is not indicated for treating diseases caused by b.pertussis, c.diphtheriae or c. tetani infections.

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

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