New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - haemophilus influenzae type b vaccine 10ug (conjugated to tetanus protein (18-30µg)) - injection with diluent - 10 mcg/0.5ml - active: haemophilus influenzae type b vaccine 10ug (conjugated to tetanus protein (18-30µg)) excipient: hydrochloric acid sucrose trometamol sodium chloride water for injection - act-hib is indicated for use in infants from 2 months to 5 years of age for active immunisation against invasive disease caused by the haemophilus influenzae type b.

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

glaxosmithkline australia pty ltd - tetanus toxoid, quantity: 40 microgram/ml; haemophilus influenza type b polyribose ribitol phosphate, quantity: 20 microgram/ml - injection, powder for - excipient ingredients: water for injections; sodium chloride; lactose - hiberix is indicated for active immunisation against haemophilus influenzae type b infection in children aged from 2 months to 5 years.

Malta - English - Medicines Authority

smithkline beecham limited - haemophilus influenzae b; tetanus toxoid - powder and solvent for solution for infusion - haemophilus influenzae b 25 µg; tetanus toxoid 25 µg - vaccines

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

sanofi pasteur inc. - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen (unii: flv5i5w26r) (haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen - unii:flv5i5w26r) - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - acthib® is a vaccine indicated for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. acthib is approved for use in children 2 months through 5 years of age. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any h. influenzae type b or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of acthib vaccine [see description (11)] . acthib is not approved for use in individuals 6 years of age and older. no human or animal data are available to assess vaccine-associated risks in pregnancy. acthib is not approved for use in individuals 6 years of age and older. human or animal data are not available to assess the impact of acthib on milk production, its presence in breast milk, or its effects on the breastfed infant. safety and effectiveness of acthib have not been established in infants below the age of 6 weeks and children and adolescents 6 years of age and older [see dosage and administration (2.1)] .

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

merck sharp & dohme llc - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen (unii: luy6p8763w) (haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen - unii:luy6p8763w) - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen 7.5 ug in 0.5 ml - liquid pedvaxhib is indicated for routine vaccination against invasive disease caused by haemophilus influenzae type b in infants and children 2 to 71 months of age. liquid pedvaxhib will not protect against disease caused by haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis. as with any vaccine, vaccination with liquid pedvaxhib may not result in a protective antibody response in all individuals given the vaccine. because of the potential for immune tolerance, liquid pedvaxhib is not recommended for use in infants younger than 6 weeks of age. (see precautions.) infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see dosage and administration). hypersensitivity to any component of the vaccine or the diluent. persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.

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.

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, inactivated bordetella pertussis, hepatitis b surface antigen (rdna), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; diphtheria - vaccines - quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis b and invasive disease caused by haemophilus influenzae type b and for booster immunisation of young children during the second year of life.the use of quintanrix should be determined on the basis of official recommendations.

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

sanofi-aventis australia pty ltd - haemophilus type b polysaccharide, quantity: 10 microgram; tetanus protein, quantity: 18 microgram - injection, powder for - excipient ingredients: trometamol; sucrose - for use in infants from 2 months to 5 years of age for active immunization against invasive disease caused by the haemophilus influenzae type b.

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

sanofi-aventis australia pty ltd - haemophilus type b polysaccharide, quantity: 10 microgram; tetanus protein, quantity: 18 microgram - injection, powder for - excipient ingredients: trometamol; sucrose - for use in infants from 2 months to 5 years of age for active immunization against invasive disease caused by the haemophilus influenzae type b.