Philippines - English - FDA (Food And Drug Administration)

sanofi pasteur inc - diptheria toxoid, tetanus toxoid, b. pertussis (whole cell), hepatitis b (r-dna) surface antigen and haemophilus influenzae type b conjugate (adsorbed) (see reverse for formulation) suspension for injection (im) - suspension for injection (im) - (see reverse for formulation)

Philippines - English - FDA (Food And Drug Administration)

sanofi pasteur inc - diptheria toxoid, tetanus toxoid, b. pertussis (whole cell), hepatitis b (r-dna) surface antigen and haemophilus influenzae type b conjugate (adsorbed) - suspension for injection (im) - (see reverse for formulation)

Philippines - English - FDA (Food And Drug Administration)

sanofi pasteur inc - diptheria toxoid, tetanus toxoid, b. pertussis (whole cell), hepatitis b (r-dna) surface antigen and haemophilus influenzae type b conjugate (adsorbed) (see reverse for formulation) suspension for injection (im) - suspension for injection (im) - (see reverse for formulation)

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

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu] (> or =); pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid 40 [iu] (> or =); haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (as prp (target fill 10mcg + 2.5mcg overage)); diphtheria toxoid, adsorbed 30 [iu] (> or =); pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid 40 [iu] (> or =) - suspension for injection - active: diphtheria toxoid, adsorbed 30 [iu] (> or =) pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid 40 [iu] (> or =) excipient: aluminium hydroxide sodium chloride water for injection active: haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (as prp (target fill 10mcg + 2.5mcg overage)) excipient: lactose monohydrate sodium chloride water active: diphtheria toxoid, adsorbed 30 [iu] (> or =) pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid 40 [iu] (> or =) excipient: aluminium hydroxide phenoxyethanol sodium chloride water for injection - infanrixtm-hib is indicated for active immunisation against diphtheria, tetanus, pertussis (dtp) and haemophilus influenzae type b (hib) infection in all children from 15 months of age.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

sanofi pasteur, kenya - diptheria toxoid,tetanus toxoid,b.pertussis,hepatitis b surface antigen & purified capsular polysaccharide (prp) , - vaccine - diptheria 30iu, tetanus 60iu, bordetella pertusis antigens 4iu, hepatitis b (rdna) 10mcg, purified capsule 10mcg ml

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

sanofi-aventis australia pty ltd - poliovirus, quantity: 32 dagu; poliovirus, quantity: 8 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: 40 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)

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; polysorbate 80; ascorbic acid; 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; inosit - 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.

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

sanofi-aventis australia pty ltd - pertussis filamentous haemagglutinin, quantity: 10 microgram/ml; pertussis fimbriae 2 + 3, quantity: 10 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis toxoid, quantity: 20 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 6 microgram/ml - injection, suspension - excipient ingredients: aluminium phosphate; water for injections; phenoxyethanol - tripacel is indciated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. tripacel is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines.

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.