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

sanofi-aventis (malaysia) sdn. bhd. - inactivated poliomyelitis virus,type 3; inactivated poliomyelitis virus,type 2; inactivated poliomyelitis virus,type 1 -

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - vaccines - infanrix penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis.

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

glaxosmithkline australia pty ltd - poliovirus; pertussis toxoid; pertussis filamentous haemagglutinin; diphtheria toxoid; pertactin; tetanus toxoid -

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 2 [iu] (2.5lfu); pertactin 2.5ug;  ; pertussis filamentous haemagglutinin 8ug;  ; pertussis toxoid, adsorbed 8ug;  ; polio virus type 1 40 dagu;  ; polio virus type 2 8 dagu;  ; polio virus type 3 32 dagu;  ; tetanus toxoid 20 [iu] (5lfu) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] (2.5lfu) pertactin 2.5ug   pertussis filamentous haemagglutinin 8ug   pertussis toxoid, adsorbed 8ug   polio virus type 1 40 dagu   polio virus type 2 8 dagu   polio virus type 3 32 dagu   tetanus toxoid 20 [iu] (5lfu) excipient: aluminium medium 199 sodium chloride water for injection - boostrix®-ipv is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of four years onwards. boostrix®-ipv is not intended for primary immunisation.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 15 lf u; pertactin 3ug; pertussis filamentous haemagglutinin 20ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 20ug; polio virus type 1 40 dagu (mahoney); polio virus type 2 8 dagu (m e f 1); polio virus type 3 32 dagu (saukett); tetanus toxoid, adsorbed 5 lf u - suspension for injection - active: diphtheria toxoid, adsorbed 15 lf u pertactin 3ug pertussis filamentous haemagglutinin 20ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 20ug polio virus type 1 40 dagu (mahoney) polio virus type 2 8 dagu (m e f 1) polio virus type 3 32 dagu (saukett) tetanus toxoid, adsorbed 5 lf u excipient: aluminium phosphate formaldehyde glutaral neomycin phenoxyethanol polymyxin b polysorbate 80 water for injection - quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis and poliomyelitis. quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 18c; pneumococcal polysaccharide serotype 19 f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 4; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 6b; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 9v - suspension for injection - pneumococcal polysaccharide serotype 19 f 3 mcg / 0.5 ml; pneumococcal polysaccharide serotype 1 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 4 3 mcg / 0.5 ml; pneumococcal polysaccharide serotype 5 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6b 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 7f 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 9v 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 14 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 18c 3 mcg / 0.5 ml; pneumococcal polysaccharide serotype 23f 1 mcg / 0.5 ml - pneumococcus, purified polysaccharides antigen conjugated - pneumococcus, purified polysaccharides antigen conjugated - active immunisation against invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae serotypes 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, and 23f in infants and children from 6 weeks up to 5 years of age.the use of synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.10.07.2017 בקשה לשינוי משטר מינוןthree-dose primary seriesthe recommended immunisation series to ensure optimal protection consists of four doses, each of 0.5 ml. the primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. the first dose may be given as early as six 6 weeks of age. a booster (fourth) dose is recommended at least 6 months after the last priming primary dose and may be given from the age of 9 months onwards (preferably between 12 and

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

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

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 18c; pneumococcal polysaccharide serotype 19 f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 4; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 6b; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 9v - suspension for injection - pneumococcal polysaccharide serotype 23f 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 18c 3 mcg / 0.5 ml; pneumococcal polysaccharide serotype 14 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 9v 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 7f 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6b 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 5 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 4 3 mcg / 0.5 ml; pneumococcal polysaccharide serotype 1 1 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19 f 3 mcg / 0.5 ml - pneumococcus purified polysaccharides antigen and haemophilus influenzae, conjugated - active immunisation against invasive disease, pneumonia and acute otitis media caused by strepococcus pneumoniae serotypes 1, 4,5,6b,7f,9v,14,18c ,19f and 23f in infants and children from 6 weeks up to 5 years of age

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.