Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis filamentous, haemagglutinin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, 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

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 60 iu/ml; pertactin 16 µg/ml;  ; pertussis filamentous haemagglutinin 50 µg/ml;  ; pertussis toxoid, adsorbed 50 µg/ml;  ; polio virus type 1 80 dagu/ml;  ; polio virus type 2 16 dagu/ml;  ; polio virus type 3 64 dagu/ml;  ; tetanus toxoid, adsorbed 80 iu/ml - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 60 iu/ml pertactin 16 µg/ml   pertussis filamentous haemagglutinin 50 µg/ml   pertussis toxoid, adsorbed 50 µg/ml   polio virus type 1 80 dagu/ml   polio virus type 2 16 dagu/ml   polio virus type 3 64 dagu/ml   tetanus toxoid, adsorbed 80 iu/ml excipient: aluminium hydroxide neomycin sulfate polymyxin b sulfate sodium chloride water for injection - infanrix®-ipv is indicated for active primary immunisation against diphtheria, tetanus, pertussis, and poliomyelitis. infanrix®-ipv is also indicated as a booster dose for children who have previously been immunised with dtp and polio antigens.

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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - diphtheria toxoid; tetanus toxoid; pertussis antigens; human poliovirus type 1 inactivated; human poliovirus type 2 inactivated; human poliovirus type 3 inactivated; haemophilus influenzae type b polysaccharide protein conjugate - powder and suspension for suspension for injection

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu] (not less than); hepatitis b surface antigen, recombinant 10ug; pertactin 8ug;  ; pertussis filamentous haemagglutinin 25ug;  ; pertussis toxoid, adsorbed 25ug;  ; polio virus type 1 40 dagu (/dose);  ; polio virus type 2 8 dagu (/dose);  ; polio virus type 3 32 dagu (/dose);  ; tetanus toxoid, adsorbed 40 [iu] (not less than); haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (covalently bonded to tetanus toxoid 20 - 40micrograms);   - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] (not less than) hepatitis b surface antigen, recombinant 10ug pertactin 8ug   pertussis filamentous haemagglutinin 25ug   pertussis toxoid, adsorbed 25ug   polio virus type 1 40 dagu (/dose)   polio virus type 2 8 dagu (/dose)   polio virus type 3 32 dagu (/dose)   tetanus toxoid, adsorbed 40 [iu] (not less than) excipient: aluminium medium 199 sodium chloride water for injection active: haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (covalently bonded to tetanus toxoid 20 - 40micrograms)   excipient: aluminium as aluminium phosphate lactose - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and haemophilus influenzae type b.

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

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; fillamentous haemagglutinin (fha); haemophilus influenzae type b polysaccharide; inactivated polio virus (ipv) type 1; inactivated polio virus (ipv) type 2; inactivated polio virus (ipv) type 3; pertactin; pertussis toxoid (pt); tetanus toxoid - powder and suspension for suspension for injection - diphtheria toxoid nlt 60 iu/ml; inactivated polio virus (ipv) type 3 64 du / 1 ml; inactivated polio virus (ipv) type 2 16 du / 1 ml; inactivated polio virus (ipv) type 1 80 du / 1 ml; pertussis toxoid (pt) 50 mcg/ml; fillamentous haemagglutinin (fha) 50 mcg/ml; pertactin 16 mcg/ml; tetanus toxoid nlt 80 iu/ml; haemophilus influenzae type b polysaccharide 20 mcg/vial - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus - active immunisation in infants from the age of 2 months to 5 years against diptheria, tetanus, pertussis, poliomyelitis and haemophilus influenza type b. booster dose for children who have previously been immunised with dtp, polio and hib antigens

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 30 iu; tetanus toxoid, quantity: 40 iu; pertussis toxoid, quantity: 50 microgram/ml; poliovirus, quantity: 80 dagu; poliovirus, quantity: 64 dagu - injection, suspension - excipient ingredients: aluminium phosphate; aluminium hydroxide hydrate; polymyxin b sulfate; water for injections; sodium chloride; neomycin sulfate; 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 - indications: infanrix penta is indicated for immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis. infanrix penta may also be used as a booster dose at 18 months of age if boosting with hepatitis b and poliomyelitits, as well as diphtheria, tetanus and pertussis is required.

European Union - English - EMA (European Medicines Agency)

mcm vaccine b.v. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3, hepatitis b surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (mahoney), type 2 (mef-1), type 3 (saukett) produced in vero cells/ haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - vaccines - vaxelis (dtap-hb-ipv-hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib). the use of vaxelis should be in accordance with official recommendations.