European Union - English - EMA (European Medicines Agency)

sanofi pasteur msd, snc - purified diphtheria toxoid, purified tetanus toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis b surface antigen, inactivated type 1 poliovirus (mahoney), inactivated type 2 poliovirus (mef 1), inactivated type 3 poliovirus (saukett), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - this combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis b caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by haemophilus influenzae type b.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - vaccines - infanrix penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis.

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 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.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur - hepatitis b surface antigen, diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens pertussis toxoid filamentous haemagglutinin, poliovirus (inactivated) type 1 (mahoney) type 2 (mef-1) type 3 (saukett), haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines, bacterial and viral vaccines, combined - hexacima (dtap-ipv-hb-hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib).the use of this vaccine should be in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur europe - filamentous haemagglutinin, haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate), hepatitis b surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (mahoney strain) produced on vero cells, poliovirus (inactivated) type 2 (mef-1 strain) produced on vero cells, poliovirus (inactivated) type 3 (saukett strain) produced on vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, diphtheria toxoid - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - hexyon (dtap-ipv-hb-hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib).the use of this vaccine should be in accordance with official recommendations.

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

sanofi-aventis australia pty ltd - pertussis filamentous haemagglutinin, quantity: 10 microgram/ml; pertussis fimbriae 2 + 3, quantity: 10 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis toxoid, quantity: 20 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 6 microgram/ml - injection, suspension - excipient ingredients: aluminium phosphate; water for injections; phenoxyethanol - tripacel is indciated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. tripacel is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines.

European Union - English - EMA (European Medicines Agency)

mcm vaccine b.v. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3, hepatitis b surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (mahoney), type 2 (mef-1), type 3 (saukett) produced in vero cells/ haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - vaccines - vaxelis (dtap-hb-ipv-hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib). the use of vaxelis should be in accordance with official recommendations.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); haemophilus b; hepatitis b vaccines; pertactin; pertussis toxoid (pt); poliovirus type 1 inactivated; poliovirus type 2 inactivated; poliovirus type 3 inactivated; tetanus toxoid - powder and suspension for suspension for injection - filamentous haemagglutinin (fha) 25 mcg/dose; diphtheria toxoid nlt 30 iu/dose; tetanus toxoid nlt 40 iu/dose; hepatitis b vaccines 10 mcg/dose; poliovirus type 1 inactivated 40 du/dose; poliovirus type 2 inactivated 8 du/dose; poliovirus type 3 inactivated 32 du/dose; haemophilus b 10 mcg/dose; pertactin 8 mcg/dose; pertussis toxoid (pt) 25 mcg/dose - bacterial and viral vaccines, combined - infantix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenza type b for infants between 6 weeks and 36 months of age.

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)

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) - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 25 [lf] in 0.5 ml - diphtheria and tetanus toxoids adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. diphtheria and tetanus toxoids adsorbed is approved for use in children from 6 weeks through 6 years of age (prior to 7th birthday). diphtheria and tetanus toxoids and acellular pertussis vaccine (dtap) or a dtap-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. diphtheria and tetanus toxoids adsorbed should be used in instances where the pertussis vaccine component is contraindicated. diphtheria and tetanus toxoids adsorbed is not to be used for treatment of diphtheria or tetanus infection. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of diphtheria and tetanus toxoids adsorbed or any other diphtheria toxoid or tetanus toxoid-containing vaccine, or any other component of this vaccine is a contraindication to administration of diphtheria and tetanus toxoids adsorbed. [see description (11). ] diphtheria and tetanu