Austrália - inglês - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - tetanus toxoid, quantity: 20 microgram/ml; meningococcal polysaccharide group c, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: sodium chloride; water for injections; aluminium hydroxide hydrate - neisvac-c vaccine is indicated for active immunisation of children from 8 weeks of age, adolescents and adults, for the prevention of invasive disease caused by neisseria meningitidis serogroup c.

Austrália - inglês - 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.

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu] (not less than); pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; polio virus type 1 40 dagu (inactivated); polio virus type 2 8 dagu (inactivated); polio virus type 3 32 dagu (inactivated); tetanus toxoid, adsorbed 40 [iu] (not less than); haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (20 - 40 mcg of tetanus toxoid per dose) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] (not less than) pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug polio virus type 1 40 dagu (inactivated) polio virus type 2 8 dagu (inactivated) polio virus type 3 32 dagu (inactivated) tetanus toxoid, adsorbed 40 [iu] (not less than) excipient: aluminium lactose medium 199 sodium chloride water for injection active: haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (20 - 40 mcg of tetanus toxoid per dose) - infanrix??-ipv+hib is indicated as a booster dose for children aged 15 months and older who have previously been immunised with dtp, polio and hib antigens. the hib component of the vaccine does not protect against diseases due to other serotypes of haemophilus influenzae nor against meningitis caused by other organisms.

Canadá - inglês - Health Canada

glaxosmithkline inc - pertussis toxoid; filamentous haemagglutinin; pertactin; diphtheria toxoid; tetanus toxoid; inactivated poliovirus type i; inactivated poliovirus type ii; inactivated poliovirus type iii - suspension - 25mcg; 25mcg; 8mcg; 30unit; 40unit; 40unit; 8unit; 32unit - pertussis toxoid 25mcg; filamentous haemagglutinin 25mcg; pertactin 8mcg; diphtheria toxoid 30unit; tetanus toxoid 40unit; inactivated poliovirus type i 40unit; inactivated poliovirus type ii 8unit; inactivated poliovirus type iii 32unit - vaccines

União Europeia - inglês - EMA (European Medicines Agency)

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

União Europeia - inglês - 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.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - pneumococcal purified capsular polysaccharides, quantity: 2.2 microgram; pneumococcal purified capsular polysaccharides, quantity: 4.4 microgram - injection, suspension - excipient ingredients: aluminium phosphate; water for injections; polysorbate 80; diphtheria crm197 protein; succinic acid; sodium chloride - active immunisation for the prevention of pneumococcal disease caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f and 23f in adults and children aged more than 6 weeks of age. the use of prevenar 13 should be guided by official recommendations.

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - streptococcus pneumoniae capsular polysaccharide protein conjugate - suspension for injection

Cingapura - inglês - 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

Armênia - inglês - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin, hepatitis b surface antigen, inactivated poliovirus type 1, inactivated poliovirus type 2, inactivated poliovirus type 3, haemophilus influenzae type b polysaccharide (conjugated to tetanus toxoid) - powder and suspension for suspension for injection - not less than 30iu/dose+ not less than 40iu/dose+ 25mcg/dose+ 25mcg/dose+ 8mcg/dose+ 10mcg/dose+ 40d-antigen unit/dose+ 8d-antig