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

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

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 15 lf u; pertactin 3ug; pertussis filamentous haemagglutinin 20ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 20ug; polio virus type 1 40 dagu (mahoney); polio virus type 2 8 dagu (m e f 1); polio virus type 3 32 dagu (saukett); tetanus toxoid, adsorbed 5 lf u - suspension for injection - active: diphtheria toxoid, adsorbed 15 lf u pertactin 3ug pertussis filamentous haemagglutinin 20ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 20ug polio virus type 1 40 dagu (mahoney) polio virus type 2 8 dagu (m e f 1) polio virus type 3 32 dagu (saukett) tetanus toxoid, adsorbed 5 lf u excipient: aluminium phosphate formaldehyde glutaral neomycin phenoxyethanol polymyxin b polysorbate 80 water for injection - quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis and poliomyelitis. quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

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

sanofi-aventis australia pty ltd - tetanus toxoid, quantity: 40 iu; pertussis fimbriae 2 + 3, quantity: 5 microgram; diphtheria toxoid, quantity: 30 iu; poliovirus, quantity: 29 dagu; poliovirus, quantity: 26 dagu; poliovirus, quantity: 7 dagu; pertussis toxoid, quantity: 20 microgram; pertactin, quantity: 3 microgram; pertussis filamentous haemagglutinin, quantity: 20 microgram - injection, suspension - excipient ingredients: polymyxin b sulfate; bovine serum albumin; formaldehyde; phenoxyethanol; glutaral; neomycin; water for injections; polysorbate 80; aluminium phosphate - quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis, and poliomyelitis.,quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

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.

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 2 [iu] ((2 lfu)); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 2.5ug; tetanus toxoid 20 [iu] ((5 lfu)) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] ((2 lfu)) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 2.5ug tetanus toxoid 20 [iu] ((5 lfu)) excipient: aluminium phosphate phenoxyethanol water for injection - adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

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

sanofi - human poliovirus type 3 inactivated; human poliovirus type 2 inactivated; human poliovirus type 1 inactivated; tetanus toxoid; diphtheria toxoid - suspension for injection

Ireland - English - HPRA (Health Products Regulatory Authority)

aj vaccines a/s - diphtheria toxoid, purified; tetanus toxoid, purified; pertussis toxoid, purified - suspension for injection in pre-filled syringe - < 2 international unit(s) - pertussis vaccines; pertussis, purified antigen, combinations with toxoids

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

sanofi-aventis australia pty ltd - tetanus protein, quantity: 22 microgram; haemophilus type b polysaccharide, quantity: 12 microgram; pertussis toxoid, quantity: 25 microgram; diphtheria toxoid, quantity: 20 iu; poliovirus, quantity: 8 dagu; poliovirus, quantity: 40 dagu; tetanus toxoid, quantity: 40 iu; pertussis filamentous haemagglutinin, quantity: 25 microgram; poliovirus, quantity: 32 dagu; hepatitis b surface antigen, quantity: 10 microgram - injection, suspension - excipient ingredients: sucrose; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; water for injections; aluminium hydroxide hydrate; trometamol; tyrosine; arginine hydrochloride; histidine; isoleucine; leucine; lysine hydrochloride; phenylalanine; threonine; tryptophan; valine; cystine; methionine - hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive infections caused by haemophilus influenzae type b. use of this vaccine should be in accordance with the national recommendation as per the current immunisation handbook.