Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin, hepatitis b surface antigen, inactivated poliovirus type 1, inactivated poliovirus type 2, inactivated poliovirus type 3, haemophilus influenzae type b polysaccharide (conjugated to tetanus toxoid) - powder and suspension for suspension for injection - not less than 30iu/dose+ not less than 40iu/dose+ 25mcg/dose+ 25mcg/dose+ 8mcg/dose+ 10mcg/dose+ 40d-antigen unit/dose+ 8d-antig

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - diphtheria toxoid tetanus toxoid pertussis toxoid filamentous haemagglutinin (fha) pertactin polio virus type 1 inactivated polio virus type 2 inactivated polio virus type 3 inactivated haemophilus influenzae type b capsular polysaccharide (prp) and tetanus toxoid tetanus vaccine adsorbed - %v/v

Singapore - English - 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

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid (d); filamentous haemagglutinin (fha); hib purified capsular polysaccharide; pertactin (prn or 69kda outer membrane protein); pertussis toxoid (pt); polio virus type 1 (inactivated); polio virus type 2 (inactivated); polio virus type 3 (inactivated); tetanus toxoid (t) - injection - min 30iu/0.5ml - diphtheria toxoid (d) min 30iu/0.5ml; filamentous haemagglutinin (fha) 25mcg/0.5ml; hib purified capsular polysaccharide 10 mcg/0.5 ml; pertactin (prn or 69kda outer membrane protein) 8mcg/0.5ml; pertussis toxoid (pt) 25mcg/0.5ml; polio virus type 1 (inactivated) 40du/0.5ml; polio virus type 2 (inactivated) 8du/0.5ml; polio virus type 3 (inactivated) 32du/0.5ml; tetanus toxoid (t) min 40iu/0.5ml

Australia - English - 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.

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.

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

sm pharmaceuticals sdn. bhd. - diphtheria toxoid; tetanus toxoid -

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin, hepatitis b surface antigen, type 1 (mahoney) 40 d antigen, type 2 (mef-1) 8d antigen, type 3 (saukett) 32d antigen, haemophilus influenzae type b polysaccharide (conjugated to tetanus toxoid) - powder and suspension for suspension for injection - not less than 30iu/0,5ml+ not less than 40iu/0,5ml+ 25mcg/0,5ml+ 25mcg/0,5ml+ 8mcg/0,5ml+ 10mcg /0,5ml+ units/0,5ml+ units/0,5ml+ units/0,5ml+ 10mcg /0,5ml

Malta - English - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - purified tetanus toxoid; purified diphtheria toxoid ph. eur.; adsorbed purified pertussis toxoid; adsorbed purified filamentous haemagglutinin; inactivated poliomyelitis virus ph. eur; inactivated type 1 poliovirus; inactivated type 2 poliovirus; inactivated type 3 poliovirus - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - bacterial and viral vaccines, combined; diphtheria-pertussis-poliomyelitis-tetanus