Canada - English - Health Canada

glaxosmithkline inc - haemophilus influenzae type b-prp; filamentous haemagglutinin; pertactin; hepatitis b surface antigen (recombinant); diphtheria toxoid; tetanus toxoid; poliovirus type 1 mahoney (inactivated); poliovirus type 2 mef1 (inactivated); poliovirus type 3 saukett (inactivated); pertussis toxoid; tetanus toxoid adsorbed - suspension - 10mcg; 25mcg; 8mcg; 10mcg; 25lf; 10lf; 40unit; 8unit; 32unit; 25mcg; 40mcg - haemophilus influenzae type b-prp 10mcg; filamentous haemagglutinin 25mcg; pertactin 8mcg; hepatitis b surface antigen (recombinant) 10mcg; diphtheria toxoid 25lf; tetanus toxoid 10lf; poliovirus type 1 mahoney (inactivated) 40unit; poliovirus type 2 mef1 (inactivated) 8unit; poliovirus type 3 saukett (inactivated) 32unit; pertussis toxoid 25mcg; tetanus toxoid adsorbed 40mcg - vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

wyeth (nz) ltd - haemophilus influenzae type b oligosaccharide vaccine-crm 197 conjugate 50 µg/ml; haemophilus influenzae type b prp 20 µg/ml - solution for injection - 10 mcg/0.5ml - active: haemophilus influenzae type b oligosaccharide vaccine-crm 197 conjugate 50 µg/ml haemophilus influenzae type b prp 20 µg/ml

Singapore - English - HSA (Health Sciences Authority)

thermo scientific microbiology pte ltd - microbiology - haemophilus influenzae agglutinating sera are intended for use in the qualitative slide agglutination test and in counterimmunoelectrophoresis (cie) to identify serologically the type antigen of pathogenic strains of h. influenzae (types a to f) for epidemiological and diagnostic purposes.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - haemophilus influenzae type b polysaccharide 10ug (conjugated to tetanus protein.); bordetella pertussis, inactivated 4 [iu]; diphtheria toxoid, adsorbed 30 [iu]; tetanus toxoid 60 [iu] - solution for injection - active: haemophilus influenzae type b polysaccharide 10ug (conjugated to tetanus protein.) excipient: sucrose tris-bp active: bordetella pertussis, inactivated 4 [iu] diphtheria toxoid, adsorbed 30 [iu] tetanus toxoid 60 [iu] excipient: aluminium hydroxide sodium chloride thiomersal

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

glaxosmithkline australia pty ltd - hepatitis b surface antigen recombinant, quantity: 20 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 16 dagu; poliovirus, quantity: 64 dagu; poliovirus, quantity: 80 dagu - injection, suspension - excipient ingredients: aluminium phosphate; sodium chloride; aluminium hydroxide hydrate; neomycin sulfate; polymyxin b sulfate; water for injections; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - infanrix hexa is indicated for primary immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, and haemophilus influenzae type b. infanrix hexa is also indicated for use as booster dose if boosting with hepatitis b, poliomyelitis, and haemophilus influenzae type b, as well as diphtheria, tetanus and pertussis is required. refer to dosage and administration for further information.

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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals sa-nv - conjugate of haemophilus influenzae type b capsular polysaccharide and tetanus toxoid 30 µg - 50 µg; bordetella pertussis filamentous hemagglutinin (fha) 25 µg/dose; diphtheria toxoid (dt) >= 30 iu/dose; bordetella pertussis pertactin 8 µg/dose; tetanus toxoid >= 40 iu/dose; bordetella pertussis toxoid (pt) 25 µg/dose - powder and suspension for suspension for injection - diphteria antigen, adsorbed; haemophilus influenzae type b polysaccharides, conjugated to tetanus toxoid; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - hemophilus influenzae b, combinations with toxoids

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals sa-nv - poliovirus type 2 (inactivated) 8 d-antigen u/1 dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; poliovirus type 1 (inactivated) 40 d-antigen u/1 dose; bordetella pertussis pertactin 8 µg/dose; tetanus toxoid >= 40 iu/dose; bordetella pertussis filamentous hemagglutinin (fha) 25 µg/dose; bordetella pertussis toxoid (pt) 25 µg/dose; diphtheria toxoid (dt) >= 30 iu/dose; conjugate of haemophilus influenzae type b capsular polysaccharide and tetanus toxoid - powder and solvent for suspension for injection - diphteria antigen, adsorbed; haemophilus influenzae type b polysaccharides, conjugated to tetanus toxoid; poliomyelitis virus; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sanofi pasteur europe s.a. - poliovirus type 1 (inactivated) 40 d-antigen u/1 dose; bordetella pertussis toxoid (pt) 25 µg/dose; conjugate of haemophilus influenzae type b capsular polysaccharide and tetanus toxoid 10 µg/dose; bordetella pertussis filamentous hemagglutinin (fha) 25 µg/dose; tetanus toxoid >= 40 iu/dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; diphtheria toxoid (dt) >= 30 iu/dose; poliovirus type 2 (inactivated) 8 d-antigen u/1 dose - powder and suspension for suspension for injection - diphteria antigen, adsorbed; haemophilus influenzae type b polysaccharides, conjugated to tetanus toxoid; poliomyelitis virus; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - haemophilus parasuis (serovar 4) strain 2170b - unknown - haemophilus parasuis (serovar 4) strain 2170b vaccine-microbial active 0.0 - active constituent