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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; poliovirus, quantity: 64 dagu; poliovirus, quantity: 80 dagu - injection, suspension - excipient ingredients: aluminium phosphate; sodium chloride; aluminium hydroxide hydrate; neomycin sulfate; polymyxin b sulfate; water for injections; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - infanrix hexa is indicated for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, and haemophilus influenzae type b. infanrix hexa is also indicated for use as booster dose if boosting with hepatitis b, poliomyelitis, and haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required. refer to dosage and administration for further information.

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

glaxosmithkline australia pty ltd - tetanus toxoid, quantity: 20 lfu/ml; poliovirus, quantity: 80 agu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; poliovirus, quantity: 16 agu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 64 agu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, solution - excipient ingredients: aluminium hydroxide hydrate; water for injections; neomycin sulfate; polymyxin b sulfate; sodium chloride; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - 1. infanrix-ipv is indicated for use in a three dose primary schedule for immunisation of infants from 6 weeks of age and over, against diphtheria, tetanus, pertussis and poliomyelitis. infanrix-ipv is also indicated as a single booster dose for children, up to and including 6 years of age, who have previously been immunised against diphthereia, tetanus, pertussis and polio.

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 hemagglutinin (fha); inactivated polio virus type 1; inactivated polio virus type 2; inactivated polio virus type 3; pertactin (prn); pertussis toxoid (pt); tetanus toxoid - injection, suspension - diphtheria toxoid 2.5 lf/ 0.5 ml - not less than 2 iu; filamentous hemagglutinin (fha) 8 mcg/0.5ml; inactivated polio virus type 1 40 du/0.5 ml; inactivated polio virus type 2 8 du/0.5 ml; inactivated polio virus type 3 32 du/0.5 ml; pertactin (prn) 2.5 mcg/0.5 ml; pertussis toxoid (pt) 8 mcg/0.5 ml; tetanus toxoid 5.0 lf/0.5ml - not less than 20 iu

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)

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.

Israel - English - Ministry of Health

medici medical ltd, israel - diphtheria toxoid; filamentous haemagglutinin (fha); fimbrae tupes 2 + 3 (fim); pertactin; pertussis acellular; tetanus toxoid - suspension for injection - pertussis acellular 10 mcg / 0.5 ml; filamentous haemagglutinin (fha) 5 mcg / 0.5 ml; fimbrae tupes 2 + 3 (fim) 5 mcg / 0.5 ml; pertactin 3 mcg / 0.5 ml; diphtheria toxoid 30 iu / 0.5 ml; tetanus toxoid 40 iu / 0.5 ml - pertussis, purified antigen, combinations with toxoids - pertussis, purified antigen, combinations with toxoids - is indicated for the primary immunization of infants at or above the age of 2 months and as a booster in children up to their 6th birthday against diphtheria, tetanus and pertussis.

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: sanofi pasteur, inc.; distributor: zuellig pharma corporation - diphtheria, tetanus, pertussis (acellular component), hepatitis b, poliomyelitis (inactivated) and haemophilus influenzae type b conjugate vaccine (adsorbed) - suspension for injection (im) - formulation: each dose (0.5 ml) contains: diphtheria toxoid' tetanus toxoid ' bordetella pertussis antigen pertussis toxoid' filamentous hemagglutinin' poliovirus (inactivated)2.3 type i (mahoney) strain nlt 20 iu nlt 40 iu hepatitis b surface antigen haemophilus influenzae type b polysaccharide phosphate) 10 mcg (polyribosylribitol 12 mcg conjugate to tetanus protein 22-36 mcg 25 mcg 25 mcg 40 d antigen units type ii (mef-1) strain" type iii (saukett) strain1 8 d antigen units 32 d antigen units 'adsorbed on aluminium hydroxide, hydrated (al(oh)3) 2produced in yeast cells (saccharomyces cerevisiae) by recombinant dna technology 3adsorbed on aluminium phosphate (aipo4) *propagated in vero cells

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals sa-nv - bordetella pertussis filamentous hemagglutinin (fha) 8 µg/dose; diphtheria toxoid (dt) >= 2 iu/dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; pertactin (bordetella pertussis antigen) 2,5 µg/dose; bordetella pertussis toxoid (pt) 8 µg/dose; tetanus toxoid >= 20 iu/dose; poliovirus type 2 (inactivated) 8 d-antigen u/1 dose; poliovirus type 1 (inactivated) 40 d-antigen u/1 dose - suspension for injection in pre-filled syringe - diphteria toxoid, adsorbed; poliomyelitis virus, inactivated; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-pertussis-poliomyelitis-tetanus