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

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; fillamentous haemagglutinin (fha); haemophilus influenzae type b polysaccharide; inactivated polio virus (ipv) type 1; inactivated polio virus (ipv) type 2; inactivated polio virus (ipv) type 3; pertactin; pertussis toxoid (pt); tetanus toxoid - powder and suspension for suspension for injection - diphtheria toxoid nlt 60 iu/ml; inactivated polio virus (ipv) type 3 64 du / 1 ml; inactivated polio virus (ipv) type 2 16 du / 1 ml; inactivated polio virus (ipv) type 1 80 du / 1 ml; pertussis toxoid (pt) 50 mcg/ml; fillamentous haemagglutinin (fha) 50 mcg/ml; pertactin 16 mcg/ml; tetanus toxoid nlt 80 iu/ml; haemophilus influenzae type b polysaccharide 20 mcg/vial - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus - active immunisation in infants from the age of 2 months to 5 years against diptheria, tetanus, pertussis, poliomyelitis and haemophilus influenza type b. booster dose for children who have previously been immunised with dtp, polio and hib antigens

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)] .

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - diphtheria toxoid, adsorbed 15 lf u; pertactin 3ug (adsorbed); pertussis filamentous haemagglutinin 20ug (adsorbed); pertussis fimbriae 2+3 5ug (adsorbed); pertussis toxoid, adsorbed 20ug; polio virus type 1 40 dagu (inactivated); polio virus type 2 8 dagu (inactivated); polio virus type 3 32 dagu (inactivated); tetanus toxoid, adsorbed 5 lf u; haemophilus influenzae type b polysaccharide 10ug (conjugated to tetanus protein (18-30µg)) - combination - active: diphtheria toxoid, adsorbed 15 lf u pertactin 3ug (adsorbed) pertussis filamentous haemagglutinin 20ug (adsorbed) pertussis fimbriae 2+3 5ug (adsorbed) pertussis toxoid, adsorbed 20ug polio virus type 1 40 dagu (inactivated) polio virus type 2 8 dagu (inactivated) polio virus type 3 32 dagu (inactivated) tetanus toxoid, adsorbed 5 lf u excipient: aluminium phosphate bovine serum albumin formaldehyde glutaral neomycin phenoxyethanol polymyxin b polysorbate 80 water for injection active: haemophilus influenzae type b polysaccharide 10ug (conjugated to tetanus protein (18-30µg)) excipient: sucrose trometamol - poliacel® is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, whooping cough, poliomyelitis and invasive haemophilus influenzae type b disease. poliacel® is also indicated for the fourth dose for children from 15 to 20 months who have been immunised previously with up to three doses of diphtheria, tetanus, pertussis, polio and haemophilus influenzae type b disease vaccines.

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

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

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.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

sanofi pasteur - diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis b surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein - suspension for injection - 20iu/0,5ml+ 40iu/0,5ml+ 25/25mcg/0,5ml+ 40/8/32 du/0,5ml+ 10mcg/0,5ml+ 12mcg/0,5ml+ 22-36mcg/0,5ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

sanofi pasteur - diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis b surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein - suspension for injection - 20iu/0,5ml+ 40iu/0,5ml+ 25/25mcg/0,5ml+ 40/8/32 du/0,5ml+ 10mcg/0,5ml+ 12mcg/0,5ml+ 22-36mcg/0,5ml