アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), 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), hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p), poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 25 [iu] in 0.5 ml - pediarix is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis b virus, and poliomyelitis. pediarix is approved for use as a 3-dose series in infants born of hepatitis b surface antigen (hbsag)-negative mothers. pediarix may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday). a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis b-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin b, is a contraindication to administration of pediarix [see description (11)] . 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 pediarix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including pediarix. pediarix should not be administered to individuals with such conditions until the neurologic status is clarified and stabilized. safety and effectiveness of pediarix were established in the age group 6 weeks through 6 months on the basis of clinical studies [see adverse reactions (6.1), clinical studies (14.1, 14.2)] . safety and effectiveness of pediarix in the age group 7 months through 6 years are supported by evidence in infants aged 6 weeks through 6 months. safety and effectiveness of pediarix in infants younger than 6 weeks and children aged 7 to 16 years have not been evaluated.

オーストラリア - 英語 - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; poliovirus, quantity: 64 dagu; poliovirus, quantity: 80 dagu - injection, suspension - excipient ingredients: aluminium phosphate; sodium chloride; aluminium hydroxide hydrate; neomycin sulfate; polymyxin b sulfate; water for injections; 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 - infanrix hexa is indicated for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, and haemophilus influenzae type b. infanrix hexa is also indicated for use as booster dose if boosting with hepatitis b, poliomyelitis, and haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required. refer to dosage and administration for further information.

ベルギー - 英語 - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals sa-nv - bordetella pertussis filamentous hemagglutinin (fha) 8 µg/dose; diphtheria toxoid (dt) >= 2 iu/dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; pertactin (bordetella pertussis antigen) 2,5 µg/dose; bordetella pertussis toxoid (pt) 8 µg/dose; tetanus toxoid >= 20 iu/dose; poliovirus type 2 (inactivated) 8 d-antigen u/1 dose; poliovirus type 1 (inactivated) 40 d-antigen u/1 dose - suspension for injection in pre-filled syringe - diphteria toxoid, adsorbed; poliomyelitis virus, inactivated; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-pertussis-poliomyelitis-tetanus

ベルギー - 英語 - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sanofi pasteur europe s.a. - poliovirus type 1 (inactivated) 40 d-antigen u/0,5 ml; poliovirus type 3 (inactivated) 32 d-antigen u/0,5 ml; poliovirus type 2 (inactivated) 8 d-antigen u/0,5 ml - suspension for injection - poliomyelitis virus - poliomyelitis, trivalent, inactivated, whole virus

欧州連合 - 英語 - 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.

ニュージーランド - 英語 - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 2 [iu] (nlt, equiv to 2 lf per dose); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 2.5ug; polio virus type 1 29 dagu (mahoney, by parallel line method (equiv to 40 dagu by sigmoid method)); polio virus type 2 7 dagu (mef 1, by parallel line method (equiv to 8 dagu by sigmoid method)); polio virus type 3 26 dagu (saukett, by parallel line method (equiv to 32 dagu by sigmoid method)); tetanus toxoid 20 [iu] (nlt, equiv to 5 lf per dose) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] (nlt, equiv to 2 lf per dose) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 2.5ug polio virus type 1 29 dagu (mahoney, by parallel line method (equiv to 40 dagu by sigmoid method)) polio virus type 2 7 dagu (mef 1, by parallel line method (equiv to 8 dagu by sigmoid method)) polio virus type 3 26 dagu (saukett, by parallel line method (equiv to 32 dagu by sigmoid method)) tetanus toxoid 20 [iu] (nlt, equiv to 5 lf per dose) excipient: aluminium phosphate ethanol phenoxyethanol polysorbate 80 water for injection - adacel® polio is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation. children 4-6 years of age should have already received four doses of dtpa and ipv or opv. adacel® polio is not intended for primary immunisation. adacel® polio may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus. the use of adacel® polio should be determined on the basis of official recommendations.

シンガポール - 英語 - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - conjugate of streptococcus pneumoniae type 1 & haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 14 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 18c and tetanus toxoid; conjugate of streptococcus pneumoniae type 19f and diphtheria toxoid; conjugate of streptococcus pneumoniae type 23f and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 4 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 5 and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 6b and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 7f and haemophilus influenzae protein d; conjugate of streptococcus pneumoniae type 9v and haemophilus influenzae protein d; diphtheria toxoid (dt) carrier protein; polysaccharide (ps); protein-d (pd) carrier protein (derived from non-typeable haemophilus influenzae); tetanus toxoid (tt) carrier protein - injection, suspension - 1 μg ps1; 1.11-1.67 μg pd/dose - conjugate of streptococcus pneumoniae type 1 & haemophilus influenzae protein d 1 μg ps1; 1.11-1.67 μg pd/dose; conjugate of streptococcus pneumoniae type 14 and haemophilus influenzae protein d 1 μg ps14; 1.00-1.82 μg pd/dose; conjugate of streptococcus pneumoniae type 18c and tetanus toxoid 3 μg ps18c; 5.45-10.00 μg tt/dose; conjugate of streptococcus pneumoniae type 19f and diphtheria toxoid 3 μg ps19f; 3.33-6.00 μg dt/dose; conjugate of streptococcus pneumoniae type 23f and haemophilus influenzae protein d 1 μg ps23f; 0.39-0.74 μg pd/dose; conjugate of streptococcus pneumoniae type 4 and haemophilus influenzae protein d 3 μg ps4; 3.33-6.67 μg pd/dose; conjugate of streptococcus pneumoniae type 5 and haemophilus influenzae protein d 1 μg ps5; 0.67-1.25 μg pd/dose; conjugate of streptococcus pneumoniae type 6b and haemophilus influenzae protein d 1 μg ps6b; 0.56-0.95 μg pd/dose; conjugate of streptococcus pneumoniae type 7f and haemophilus influenzae protein d 1 μg ps7f; 0.87-1.43 μg pd/dose; conjugate of streptococcus pneumoniae type 9v and haemophilus influenzae protein d 1 μg ps9v; 1.00-1.82 μg pd/dose; diphtheria toxoid (dt) carrier protein 3-6 μg dt/dose (total dt content); polysaccharide (ps) 16 μg/dose (total ps content); protein-d (pd) carrier protein (derived from non-typeable haemophilus influenzae) 9-16 μg pd/dose (total pd content); tetanus toxoid (tt) carrier protein 5-10 μg/dose (total tt content)

ベルギー - 英語 - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sanofi pasteur europe s.a. - poliovirus type 2 (inactivated) 8 d-antigen u; tetanus toxoid >= 20 iu/dose; diphtheria toxoid (dt) >= 2 iu/dose; poliovirus type 1 (inactivated) 40 d-antigen u; poliovirus type 3 (inactivated) 32 d-antigen u - suspension for injection - diphteria antigen, adsorbed; poliomyelitis virus; tetanus toxoid adsorbed - diphtheria-poliomyelitis-tetanus

ベルギー - 英語 - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sanofi pasteur europe s.a. - poliovirus type 1 (inactivated) 40 d-antigen u/1 dose; diphtheria toxoid (dt) >= 30 iu; tetanus toxoid >= 40 iu; aluminium hydroxide 0,3 mg; poliovirus type 2 (inactivated) 8 d-antigen u/1 dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; bordetella pertussis toxoid (pt) 25 µg; bordetella pertussis filamentous hemagglutinin (fha) 25 µg - suspension for injection - diphteria antigen, adsorbed; poliomyelitis virus; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-pertussis-poliomyelitis-tetanus

フィリピン - 英語 - FDA (Food And Drug Administration)

n/a; importer: faberco life sciences inc.; distributor: faberco life sciences inc. - inactivated poliomyelitis vaccine (types 1, 2 and 3) - suspension for injection (im/sc) - formulation: each dose (0.5 ml) contains: poliovirus type 1, mahoney strain (inactivated)-40 d antigen units poliovirus type 2,