Ierland - Engels - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - tetanus toxoid diphtheria toxoid pertussis toxoid filamentous haemagglutinin (fha) pertactin polio virus type 1 inactivated polio virus type 2 inactivated polio virus type 3 inactivated adsorbed fimbriae types 2 + 3 - suspension for injection - %v/v

Singapore - Engels - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - human-bovine rotavirus g1; human-bovine rotavirus g2; human-bovine rotavirus g3; human-bovine rotavirus g4; human-bovine rotavirus p1 - solution - 2.2 x exponential 6 infectious units - human-bovine rotavirus g1 2.2 x exponential 6 infectious units; human-bovine rotavirus g2 2.8 x exponential 6 infectious units; human-bovine rotavirus g3 2.2 x exponential 6 infectious units; human-bovine rotavirus g4 2.0 x exponential 6 infectious units; human-bovine rotavirus p1 2.3 x exponential 6 infectious units

Australië - Engels - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - tetanus protein, quantity: 22 microgram; haemophilus type b polysaccharide, quantity: 12 microgram; pertussis toxoid, quantity: 25 microgram; diphtheria toxoid, quantity: 20 iu; poliovirus, quantity: 8 dagu; poliovirus, quantity: 40 dagu; tetanus toxoid, quantity: 40 iu; pertussis filamentous haemagglutinin, quantity: 25 microgram; poliovirus, quantity: 32 dagu; hepatitis b surface antigen, quantity: 10 microgram - injection, suspension - excipient ingredients: sucrose; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; water for injections; aluminium hydroxide hydrate; trometamol; tyrosine; arginine hydrochloride; histidine; isoleucine; leucine; lysine hydrochloride; phenylalanine; threonine; tryptophan; valine; cystine; methionine - hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive infections caused by haemophilus influenzae type b. use of this vaccine should be in accordance with the national recommendation as per the current immunisation handbook.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 8 microgram; tetanus toxoid, quantity: 20 iu; pertactin, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 8 microgram; poliovirus, quantity: 32 agu - injection, suspension - excipient ingredients: polysorbate 80; aluminium hydroxide hydrate; sodium chloride; neomycin sulfate; water for injections; aluminium phosphate; polymyxin b sulfate; glucose monohydrate; 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; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - boostrix-ipv is indicated for booster vaccination against diphtheria, tetanus, pertussis and polio of individuals from the age of four years onwards.,boostrix-ipv 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 nhmrc currently recommends only 4 doses of polio vaccines in childhood, and that polio boosters for adults are not necessary unless they are at special risk, such as:,? travellers to areas or countries where poliomyelitis is epidemic or endemic;,? health care workers in possible contact with poliomyelitis cases.,for those exposed to continuing risk of infection a single booster dose is desirable every 10 years.,the nhmrc currently recommends boosting against diphtheria, tetanus and pertussis using an adolescent/adult formulation dtpa at 15 to 17 years of age. before the eighth birthday, dtp-containing vaccines should be given, as they contain a larger dose of diphtheria toxoid. after the eighth birthday, smaller doses of toxoid (adult/adolescent formulation dtpa or dt-containing vaccines) should be given.,a booster dose of dtpa is also recommended:,? before planning pregnancy, or for both parents as soon as possible after delivery of an infant,? for adults working with young children,? for any adult expressing an interest in receiving a booster dose of dtpa, provided that a primary course of dtp vaccine has been given in the past.,clinical data has demonstrated that in adults with an unknown history of pertussis vaccination, the majority had an immunogenic response to pertussis when given boostrix-ipv (see section 5.1 pharmacodynamic properties).,finally, all adults who reach the age of 50 years without having received a boosting dose of dt in the previous 5 years should receive a further boosting dose of dt, where the adult/adolescent formulation dtpa can be used instead.,boostrix-ipv is not intended for primary immunisation.

Maleisië - Engels - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glaxosmithkline pharmaceutical sdn. bhd. - diphtheria toxoid; tetanus toxoid; pertussis toxoid (pt); haemophilus influenza type b conjugate to; pertactin (69 kda outer membrane protein-69k); inactivated polio virus type 3; inactivated polio virus type 2; inactivated polio virus type 1; filamentous haemagglutinin (fha); r-dna hepatitis b antigen -

Maleisië - Engels - 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) -

Malta - Engels - 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

Singapore - Engels - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - diphtheria toxoid; filamentous haemagglutinin; haemophilus influenza type b polysaccharide (polyribosylribitol phosphate) conjugated to 22 - 36 μg tetanus protein (prp-t); hepatitis b surface antigen; pertussis toxoid; poliovirius (inactivated) type 1 (mahoney); poliovirus (inactivated) type 2 (mef-1); poliovirus (inactivated) type 3 (saukett); tetanus toxoid - injection, suspension - diphtheria toxoid 30 lf (>= 20 iu)/0.5 ml; filamentous haemagglutinin 25 μg/0.5 ml; haemophilus influenza type b polysaccharide (polyribosylribitol phosphate) conjugated to 22 - 36 μg tetanus protein (prp-t) 12 μg/0.5 ml; hepatitis b surface antigen 10 μg/0.5 ml; pertussis toxoid 25 μg/0.5 ml; poliovirius (inactivated) type 1 (mahoney) 40 du/0.5 ml; poliovirus (inactivated) type 2 (mef-1) 8 du/0.5 ml; poliovirus (inactivated) type 3 (saukett) 32 du/0.5 ml; tetanus toxoid 10 lf (>= 40 iu)/0.5 ml

Armenië - Engels - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

sanofi pasteur - diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis b surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein - suspension for injection - 20iu/0,5ml+ 40iu/0,5ml+ 25/25mcg/0,5ml+ 40/8/32 du/0,5ml+ 10mcg/0,5ml+ 12mcg/0,5ml+ 22-36mcg/0,5ml

Armenië - Engels - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

sanofi pasteur - diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis b surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein - suspension for injection - 20iu/0,5ml+ 40iu/0,5ml+ 25/25mcg/0,5ml+ 40/8/32 du/0,5ml+ 10mcg/0,5ml+ 12mcg/0,5ml+ 22-36mcg/0,5ml