Singapūras - anglų - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid (d); filamentous haemagglutinin (fha); hib purified capsular polysaccharide; pertactin (prn or 69kda outer membrane protein); pertussis toxoid (pt); polio virus type 1 (inactivated); polio virus type 2 (inactivated); polio virus type 3 (inactivated); tetanus toxoid (t) - injection - min 30iu/0.5ml - diphtheria toxoid (d) min 30iu/0.5ml; filamentous haemagglutinin (fha) 25mcg/0.5ml; hib purified capsular polysaccharide 10 mcg/0.5 ml; pertactin (prn or 69kda outer membrane protein) 8mcg/0.5ml; pertussis toxoid (pt) 25mcg/0.5ml; polio virus type 1 (inactivated) 40du/0.5ml; polio virus type 2 (inactivated) 8du/0.5ml; polio virus type 3 (inactivated) 32du/0.5ml; tetanus toxoid (t) min 40iu/0.5ml

Airija - anglų - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - pertussis toxoid filamentous haemagglutinin (fha) pertactin diphtheria toxoid tetanus toxoid haemophilus influenzae type b polysaccharide tetanus toxoid - powder for suspension for injection

Airija - anglų - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - diphtheria toxoid tetanus toxoid pertussis toxoid filamentous haemagglutinin (fha) pertactin - suspension for injection

Didžioji Britanija - anglų - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - tetanus toxoid; pertussis antigens; diphtheria toxoid - suspension for injection

Europos Sąjunga - anglų - 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.

Europos Sąjunga - anglų - 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.

Australija - anglų - 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.

Armėnija - anglų - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

pfizer manufacturing belgium n.v. - pneumococcal polysaccharide conjugate vaccine (pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f) - suspension for injection - 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 4.4mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose+ 2.2mcg/dose

Singapūras - anglų - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid; filamentous haemagglutinin; hepatitis b surface antigen (purified); hib purified capsular polysaccharide bound to tetanus toxoid; pertactin (69 kda omp); pertussis toxoid; poliovirus type 1 (inactivated); poliovirus type 2 (inactivated); poliovirus type 3 (inactivated) - injection - min 30 iu/0.5 ml - diphtheria toxoid min 30 iu/0.5 ml; filamentous haemagglutinin 25 mcg/0.5 ml; hepatitis b surface antigen (purified) 10 mcg/0.5 ml; hib purified capsular polysaccharide bound to tetanus toxoid 10 mcg/0.5 ml; pertactin (69 kda omp) 8 mcg/0.5 ml; pertussis toxoid 25 mcg/0.5 ml; poliovirus type 1 (inactivated) 40 du/0.5 ml; poliovirus type 2 (inactivated) 8 du/0.5 ml; poliovirus type 3 (inactivated) 32 du/0.5 ml

Didžioji Britanija - anglų - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - diphtheria toxoid; tetanus toxoid; pertussis antigens; haemophilus influenzae type b polysaccharide protein conjugate - powder and solvent for suspension for injection