Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (unii: 8c367iy4ey) (bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) - unii:8c367iy4ey), bordetella pertussis pertactin antigen (formaldehyde inactivated) (unii: i05o535nv6) (bordetella pertussis pertactin antigen (formaldehyde inactivated) - unii:i05o535nv6) - clostridium tetani toxoid antigen (formaldehyde inactivated) 10 [iu] in 0.5 ml - infanrix is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday). severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of infanrix is a contraindication [see description (11)] . because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is being considered. encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including infanrix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including infanrix. pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized. safety and effectiveness of infanrix in infants aged younger than 6 weeks and children aged 7 to 16 years have not been established. infanrix is not approved for use in these age groups.

Ευρωπαϊκή Ένωση - Αγγλικά - 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.

Νέα Ζηλανδία - Αγγλικά - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 60 iu/ml; pertactin 16 µg/ml;  ; pertussis filamentous haemagglutinin 50 µg/ml;  ; pertussis toxoid, adsorbed 50 µg/ml;  ; polio virus type 1 80 dagu/ml;  ; polio virus type 2 16 dagu/ml;  ; polio virus type 3 64 dagu/ml;  ; tetanus toxoid, adsorbed 80 iu/ml - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 60 iu/ml pertactin 16 µg/ml   pertussis filamentous haemagglutinin 50 µg/ml   pertussis toxoid, adsorbed 50 µg/ml   polio virus type 1 80 dagu/ml   polio virus type 2 16 dagu/ml   polio virus type 3 64 dagu/ml   tetanus toxoid, adsorbed 80 iu/ml excipient: aluminium hydroxide neomycin sulfate polymyxin b sulfate sodium chloride water for injection - infanrix®-ipv is indicated for active primary immunisation against diphtheria, tetanus, pertussis, and poliomyelitis. infanrix®-ipv is also indicated as a booster dose for children who have previously been immunised with dtp and polio antigens.

Σιγκαπούρη - Αγγλικά - 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

Νέα Ζηλανδία - Αγγλικά - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu]; hepatitis b surface antigen, recombinant 10ug; pertactin 8ug;  ; pertussis filamentous haemagglutinin 25ug;  ; pertussis toxoid, adsorbed 25ug;  ; polio virus type 1 40 dagu (/dose);  ; polio virus type 2 8 dagu (/dose);  ; polio virus type 3 32 dagu (/dose);  ; tetanus toxoid, adsorbed 40 [iu] - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] hepatitis b surface antigen, recombinant 10ug pertactin 8ug   pertussis filamentous haemagglutinin 25ug   pertussis toxoid, adsorbed 25ug   polio virus type 1 40 dagu (/dose)   polio virus type 2 8 dagu (/dose)   polio virus type 3 32 dagu (/dose)   tetanus toxoid, adsorbed 40 [iu] excipient: aluminium hydroxide aluminium phosphate formaldehyde glycine medium 199 monobasic potassium phosphate neomycin sulfate polymyxin b sulfate polysorbate 20 potassium chloride sodium chloride sodium phosphate (32p) water for injection - infanrix®-penta is indicated for immunisation against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis in infants from the age of 6 weeks and may also be given to infants who received a first dose of hepatitis b vaccine at birth.

Αρμενία - Αγγλικά - 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

Αρμενία - Αγγλικά - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin - suspenion for injection - not less than 30iu/dose+ not less than 40iu/dose+ 25mcg/dose+ 25mcg/dose+ 8mcg/dose

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 30 iu; tetanus toxoid, quantity: 40 iu; pertussis toxoid, quantity: 50 microgram/ml; poliovirus, quantity: 80 dagu; poliovirus, quantity: 64 dagu - injection, suspension - excipient ingredients: aluminium phosphate; aluminium hydroxide hydrate; polymyxin b sulfate; water for injections; sodium chloride; neomycin sulfate; 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 - indications: infanrix penta is indicated for immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis. infanrix penta may also be used as a booster dose at 18 months of age if boosting with hepatitis b and poliomyelitits, as well as diphtheria, tetanus and pertussis is required.

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - diphtheria toxoid tetanus toxoid pertussis toxoid filamentous haemagglutinin (fha) pertactin polio virus type 1 inactivated polio virus type 2 inactivated polio virus type 3 inactivated haemophilus influenzae type b capsular polysaccharide (prp) and tetanus toxoid tetanus vaccine adsorbed - %v/v

Μάλτα - Αγγλικά - Medicines Authority

smithkline beecham limited - pertactin; pertussis filamentous haemagglutinin; pertussis toxoid; poliovirus (inactivated) type 1 (mahoney strain); poliovirus (inactivated) type 2 (mef-1 strain); poliovirus (inactivated) type 3 (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