Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - purified diphtheria toxoid ph. eur.; purified tetanus toxoid; adsorbed purified pertussis toxoid; adsorbed purified filamentous haemagglutinin; inactivated poliomyelitis virus ph. eur; inactivated type 1 poliovirus; inactivated type 2 poliovirus; inactivated type 3 poliovirus; haemophilus influenzae type b, conjugate with tetanus protein - powder for suspension for injection - 0.5 millilitre(s) - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: sanofi pasteur, inc; distributor: zuellig pharma corporation - diphtheria, tetanus, pertussis (acellular poliomyelitis (inactivated) vaccine and haemophilus influenzae type b conjugate vaccine (adsorbed) - suspension and powder for suspension for injection (im) - after reconstitution, each dose (0.5 ml) contains: diphtheria toxoid tetanus toxoid bordetella pertussis antigen pertussis toxoid filamentous hemagglutinin poliovirus (inactivated) >30 iu >40 iu polysaccharide influenzae type b conjugated to tetanus protein of haemophilus 10 mcg 18-30 mcg 25 mcg 25 mcg type i poliomyelitis virus (inactivated) 40 d antigen units type ii poliomyelitis virus (inactivated) 8 d antigen units type iii poliomyelitis virus (inactivated) 32 d' antigen

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.

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis filamentous, haemagglutinin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, haemophilus influenzae, type b, polysaccharide, polyribosylribitol phosphate, tetanus toxoid - powder and suspension for suspension for injection - pertactin 8 µg pertussis filamentous haemagglutinin 25 µg pertussis toxoid 25 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu/0.5ml poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu/0.5ml poliovirus (inactivated) type 3 (saukett strain) 32 dagu/0.5ml diphtheria toxoid haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg tetanus toxoid - vaccines

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - tetanus toxoid, diphtheria toxoid, haemophilus type, b polysaccharide, polyribosylribitol phosphate, conjugated to, as carrier, protein, bordetella pertussis - powder and suspension for suspension for injection - diphtheria toxoid haemophilus type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus toxoid as carrier protein 10 µg bordetella pertussis 4 iu tetanus toxoid 60 iu - vaccines

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.

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

glaxosmithkline biologicals sa - haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen (unii: c9r35m8xv6) (haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen - unii:c9r35m8xv6) - haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - hiberix is indicated for active immunization for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. hiberix is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday). 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 hiberix [see description (11)] . safety and effectiveness of hiberix in children younger than 6 weeks and in children aged 5 to 16 years have not been established.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a clinect nz pty ltd - 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - haemophilus influenzae type b, conjugate with tetanus protein - pdr+solv for soln for inj - 10mcg/0.5m microgram/ml - hemophilus influenzae b vaccines

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