Canada - English - Health Canada

aventis pasteur limited - poliovirus vaccine live orl-trival human type-1; poliovirus vaccine live orl-trival human type-2; poliovirus vaccine live orl-trival human type-3 - solution - 1000000unit; 100000unit; 150000unit - poliovirus vaccine live orl-trival human type-1 1000000unit; poliovirus vaccine live orl-trival human type-2 100000unit; poliovirus vaccine live orl-trival human type-3 150000unit - vaccines

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

Kenya - English - Pharmacy and Poisons Board

sanofi pasteur s.a. 2, avenue pont pasteur 69007 lyon france - poliomyelitis virus type 1, ls c2ab strain,… - suspension and effervescent granules for oral - each 0.1-ml dose (2 drops) contains:poliomyelitis… - viral vaccines: poliomyelitis vaccines

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - 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 (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (unii: 8c367iy4ey) (bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) - unii:8c367iy4ey), bordetella pertussis pertactin antigen (unii: 63gd90pp8x) (bordetella pertussis pertactin antigen - unii:63gd90pp8x), bordetella pertussis fimbriae 2/3 antigen (unii: 1o0600285a) (bordetella pertussis fimbriae 2/3 antigen - unii:1o0600285a), 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) - pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to haemophilus influenzae type b. pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday). a severe allergic reaction (eg, anaphylaxis) after a previous dose of pentacel or any other diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, inactivated poliovirus vaccine or h. influenzae type b vaccine, or any ingredient of this vaccine is a contraindication to administration of pentacel [see description (11) ]. encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days 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 pentacel. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine including pentacel. pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. the safety and effectiveness of pentacel was established in the age group 6 weeks through 18 months on the basis of clinical studies [see clinical trials experience (6.1) and clinical studies (14) ]. the safety and effectiveness of pentacel in the age group 19 months through 4 years is supported by evidence in children 6 weeks through 18 months. the safety and effectiveness of pentacel in infants less than 6 weeks of age and in children 5 to 16 years of age have not been established.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); inactivated polio virus (ipv) type 1; inactivated polio virus (ipv) type 2; inactivated polio virus (ipv) type 3; pertactin (prn or 69 kda omp); pertussis toxoid vaccine; tetanus toxoid - suspension for injection - pertactin (prn or 69 kda omp) 2.5 mcg / 0.5 ml; diphtheria toxoid nlt 2 iu / 0.5 ml; tetanus toxoid nlt 20 iu / 0.5 ml; filamentous haemagglutinin (fha) 8 mcg / 0.5 ml; pertussis toxoid vaccine 8 mcg / 0.5 ml; inactivated polio virus (ipv) type 3 32 du / 0.5 ml; inactivated polio virus (ipv) type 1 40 du / 0.5 ml; inactivated polio virus (ipv) type 2 8 du / 0.5 ml - bacterial and viral vaccines, combined - for booster vaccination against diphtheria, tetanus and pertusis and poliomyelitis of individuals from the age of three years onwards. the administration of boostrix polio should be based on official recommendations.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - polio virus type 1 1e+006 ccid50 (strain lsc 2ab (sabin) not less than 6 log10);  ; polio virus type 2 100000 ccid50 (strain p712 2ab (sabin) not less than 5 log10);  ; polio virus type 3 316227 ccid50 (strain leon 12a 1b (sabin) not less than 5.5 log10);   - oral suspension - 1.4e+006 tcid50 - active: polio virus type 1 1e+006 ccid50 (strain lsc 2ab (sabin) not less than 6 log10)   polio virus type 2 100000 ccid50 (strain p712 2ab (sabin) not less than 5 log10)   polio virus type 3 316227 ccid50 (strain leon 12a 1b (sabin) not less than 5.5 log10)   excipient: arginine magnesium chloride hexahydrate neomycin sulfate polymyxin b sulfate polysorbate 80 purified water

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - polio virus type 1 1e+006 ccid50 (strain lsc, 2ab (sabin), not less than 6 log 10);  ; polio virus type 2 100000 ccid50 (strain p712, 2ab (sabin), ie. not less than 5 log 10);  ; polio virus type 3 630957 ccid50 (strain leon 12a, 1b (sabin), not less than 5.8 log 10);   - oral suspension - active: polio virus type 1 1e+006 ccid50 (strain lsc, 2ab (sabin), not less than 6 log 10)   polio virus type 2 100000 ccid50 (strain p712, 2ab (sabin), ie. not less than 5 log 10)   polio virus type 3 630957 ccid50 (strain leon 12a, 1b (sabin), not less than 5.8 log 10)   excipient: arginine magnesium chloride hexahydrate neomycin sulfate polymyxin b sulfate polysorbate 80 purified water

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection - diphtheria toxoid filamentous haemagglutinin (fha) 8 µg pertactin 2.5 µg pertussis toxoid 8 µg 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 tetanus toxoid - vaccines

Canada - English - Health Canada

sanofi pasteur limited - poliovirus type 1 mahoney (inactivated); poliovirus type 2 mef1 (inactivated); poliovirus type 3 saukett (inactivated) - solution - 29unit; 7unit; 26unit - poliovirus type 1 mahoney (inactivated) 29unit; poliovirus type 2 mef1 (inactivated) 7unit; poliovirus type 3 saukett (inactivated) 26unit - vaccines

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - poliomyelitis virus (sabin strain) type min 1000000 tcid50/0.5 ml - suspension - min 1000000 tcid50/0.5 ml