Belgium - English - 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

European Union - English - 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.

United States - English - 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 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), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), 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 - a single dose of kinrix is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (dtap) vaccine series and the fourth dose in the inactivated poliovirus vaccine (ipv) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous dtap vaccine doses have been with infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) and/or pediarix [diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine] for the first 3 doses and infanrix for the fourth dose. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis- or poliovirus-containing vaccine, or to any component of kinrix, including neomycin and polymyxin b, is a contraindication to administration of kinrix [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 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 kinrix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including kinrix. pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. safety and effectiveness of kinrix in children younger than 4 years and children aged 7 to 16 years have not been evaluated. kinrix is not approved for use in persons in these age groups.

New Zealand - English - 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.

Singapore - English - 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)

Belgium - English - 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

Belgium - English - 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

Philippines - English - 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,

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - poliovirus, inactivated, type, mahoney strain, mef, saukett strain - suspension for injection - poliovirus (inactivated) type 1 (mahoney strain) 8 dagu poliovirus (inactivated) type 2 (mef-1 strain) 40 dagu poliovirus (inactivated) type 3 (saukett strain) 40 dagu - vaccines

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - poliovirus, inactivated, type, mahoney strain, mef, saukett strain - suspension for injection - poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu - vaccines