Philippines - English - FDA (Food And Drug Administration)

n/a; importer: sanofi pasteur, inc.; distributor: n/a - inactivated poliomyelitis vaccine (type 1,2 and 3) - suspension for injection (im/sc) - formulation: one dose (0.5 ml) contains: poliovirus type 1, mahoney strain (inactivated)-40 d-antigen units poliovirus type 2, mff-i strain (inactivated)- 8 d-antigen units poliovirus type 3, saukett strain (inactivated) - 32 d-antigen units

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

sanofi-aventis australia pty ltd - poliovirus, quantity: 17 dagu; poliovirus, quantity: 20 dagu; poliovirus, quantity: 5 dagu - injection, suspension - excipient ingredients: sodium hydroxide; hydrochloric acid; formaldehyde solution; phenoxyethanol; glucose monohydrate; purified water; polysorbate 80; ascorbic acid; sodium chloride; aminobenzoic acid; adenosine phosphate; dl-alpha-tocopheryl phosphate disodium; magnesium sulfate; monobasic potassium phosphate; deoxyribose; calcium chloride dihydrate; iron trinitrate; potassium chloride; magnesium sulfate heptahydrate; potassium nitrate; sodium selenite; monobasic sodium phosphate; dibasic sodium phosphate heptahydrate; adenine sulfate; adenosine triphosphate disodium; cholesterol; glutathione; guanine hydrochloride; hypoxanthine; phenolsulfonphthalein; ribose; sodium acetate; thymine; uracil; xanthine; sodium pyruvate; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; hydroxyproline; isoleucine; asparagine; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; - ipol is indicated for active immunisation of infants, children and adults for the prevention of poliomyelitis. ipol should be offered to patients who have refused opv or in whom opv is contraindicated. ipol is also indicated for: 1) the primary vaccination of immunocompromised individuals of all ages, and household contacts of such individuals (when vaccination is indicated); (2) unvaccinated or inadequately vaccinated(*) adults, particularly if at increased risk of exposure to live polio virus, including: - travellers to areas or countries where poliomyelitis is epidemic or endemic: - laboratory workers handling specimens which may contain polio virus; - health care workers in close contact with patients who may be excreting polioviruses. (*) such as those who may not have completed a primary series of vaccination or not received a booster dose since infancy. idications as at 9 june 2003: ipol is indicated for active immunisation of infants, children and adults for the prevention of poliomyelitis. recommen

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 in pre-filled syringe - 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 diphtheria toxoid filamentous haemagglutinin (fha) 8 µg tetanus toxoid - vaccines

European Union - English - EMA (European Medicines Agency)

sanofi pasteur msd, snc - purified diphtheria toxoid, purified tetanus toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis b surface antigen, inactivated type 1 poliovirus (mahoney), inactivated type 2 poliovirus (mef 1), inactivated type 3 poliovirus (saukett), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - this combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis b caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by haemophilus influenzae type b.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); inactivated polio virus (ipv) type 1; inactivated polio virus (ipv) type 2; inactivated polio virus (ipv) type 3; pertactin (prn or 69 kda omp); pertussis toxoid vaccine; tetanus toxoid - suspension for injection - pertactin (prn or 69 kda omp) 2.5 mcg / 0.5 ml; diphtheria toxoid nlt 2 iu / 0.5 ml; tetanus toxoid nlt 20 iu / 0.5 ml; filamentous haemagglutinin (fha) 8 mcg / 0.5 ml; pertussis toxoid vaccine 8 mcg / 0.5 ml; inactivated polio virus (ipv) type 3 32 du / 0.5 ml; inactivated polio virus (ipv) type 1 40 du / 0.5 ml; inactivated polio virus (ipv) type 2 8 du / 0.5 ml - bacterial and viral vaccines, combined - for booster vaccination against diphtheria, tetanus and pertusis and poliomyelitis of individuals from the age of three years onwards. the administration of boostrix polio should be based on official recommendations.

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 -

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

glaxosmithkline biologicals sa-nv - poliovirus type 2 (inactivated) 8 d-antigen u/1 dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; poliovirus type 1 (inactivated) 40 d-antigen u/1 dose; bordetella pertussis pertactin 8 µg/dose; tetanus toxoid >= 40 iu/dose; bordetella pertussis filamentous hemagglutinin (fha) 25 µg/dose; bordetella pertussis toxoid (pt) 25 µg/dose; diphtheria toxoid (dt) >= 30 iu/dose; conjugate of haemophilus influenzae type b capsular polysaccharide and tetanus toxoid - powder and solvent for suspension for injection - diphteria antigen, adsorbed; haemophilus influenzae type b polysaccharides, conjugated to tetanus toxoid; poliomyelitis virus; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

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

sanofi pasteur europe s.a. - poliovirus type 1 (inactivated) 40 d-antigen u/1 dose; bordetella pertussis toxoid (pt) 25 µg/dose; conjugate of haemophilus influenzae type b capsular polysaccharide and tetanus toxoid 10 µg/dose; bordetella pertussis filamentous hemagglutinin (fha) 25 µg/dose; tetanus toxoid >= 40 iu/dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; diphtheria toxoid (dt) >= 30 iu/dose; poliovirus type 2 (inactivated) 8 d-antigen u/1 dose - powder and suspension for suspension for injection - diphteria antigen, adsorbed; haemophilus influenzae type b polysaccharides, conjugated to tetanus toxoid; poliomyelitis virus; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

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.

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