Canada - English - Health Canada

glaxosmithkline inc - diphtheria toxoid adsorbed; tetanus toxoid adsorbed; pertussis toxoid adsorbed; filamentous haemagglutinin adsorbed; pertactin adsorbed; inactivated poliovirus type i; inactivated poliovirus type ii; inactivated poliovirus type iii - suspension - 2.5lf; 5.0lf; 8mcg; 8mcg; 2.5mcg; 40d; 8d; 32d - diphtheria toxoid adsorbed 2.5lf; tetanus toxoid adsorbed 5.0lf; pertussis toxoid adsorbed 8mcg; filamentous haemagglutinin adsorbed 8mcg; pertactin adsorbed 2.5mcg; inactivated poliovirus type i 40d; inactivated poliovirus type ii 8d; inactivated poliovirus type iii 32d - vaccines

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - poliovirus, quantity: 26 dagu; poliovirus, quantity: 7 dagu; pertactin, quantity: 3 microgram; tetanus toxoid, quantity: 20 iu; diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 5 microgram; pertussis fimbriae 2 + 3, quantity: 5 microgram; poliovirus, quantity: 29 dagu - injection, suspension - excipient ingredients: aluminium phosphate; formaldehyde; polysorbate 80; neomycin; water for injections; phenoxyethanol; streptomycin sulfate; polymyxin b sulfate; glutaral; ethanol - 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. for further information, refer to the current immunisation handbook.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi pasteur msd ltd - diphtheria toxoid; tetanus toxoid; pertussis antigens; human poliovirus type 1 inactivated; human poliovirus type 2 inactivated; human poliovirus type 3 inactivated - suspension for injection

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - human poliovirus type 3 inactivated; human poliovirus type 2 inactivated; human poliovirus type 1 inactivated; tetanus toxoid; diphtheria toxoid - suspension for injection

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - tetanus toxoid; pertussis antigens; human poliovirus type 3 inactivated; human poliovirus type 2 inactivated; human poliovirus type 1 inactivated; hepatitis b virus surface antigen; haemophilus influenzae type b polysaccharide protein conjugate; diphtheria toxoid - powder and suspension for suspension for injection

Canada - English - Health Canada

sanofi pasteur limited - filamentous haemagglutinin; pertussis toxoid; pertactin; tetanus toxoid; fimbriae types 2 and 3 (fim); poliovirus type 1 mahoney (inactivated); poliovirus type 2 mef1 (inactivated); poliovirus type 3 saukett (inactivated); diphtheria toxoid - suspension - 5mcg; 2.5mcg; 3mcg; 5lf; 5mcg; 29unit; 7unit; 26unit; 2lf - filamentous haemagglutinin 5mcg; pertussis toxoid 2.5mcg; pertactin 3mcg; tetanus toxoid 5lf; fimbriae types 2 and 3 (fim) 5mcg; poliovirus type 1 mahoney (inactivated) 29unit; poliovirus type 2 mef1 (inactivated) 7unit; poliovirus type 3 saukett (inactivated) 26unit; diphtheria toxoid 2lf - vaccines

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

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - diphtheria toxoid; tetanus toxoid; pertussis toxoid; filamentous haemagglutinin (fha); pertactin; type 1 (mahoney); type 2 (mef-1); type 3 (saukett) - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - diphtheria-pertussis-poliomyelitis-tetanus

Kenya - English - Pharmacy and Poisons Board

sanofi pasteur s.a. 2 avenue pont pasteur 69007 lyon - poliovirus# type 1 mahoney strain (inactivated) … - suspension for injection - one dose (0.5 ml) contains: poliovirus# type 1… - viral vaccines: poliomyelitis vaccines