Singapour - anglais - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - diphtheria toxoid; filamentous haemagglutinin; haemophilus influenza type b polysaccharide (polyribosylribitol phosphate) conjugated to 22 - 36 μg tetanus protein (prp-t); hepatitis b surface antigen; pertussis toxoid; poliovirius (inactivated) type 1 (mahoney); poliovirus (inactivated) type 2 (mef-1); poliovirus (inactivated) type 3 (saukett); tetanus toxoid - injection, suspension - diphtheria toxoid 30 lf (>= 20 iu)/0.5 ml; filamentous haemagglutinin 25 μg/0.5 ml; haemophilus influenza type b polysaccharide (polyribosylribitol phosphate) conjugated to 22 - 36 μg tetanus protein (prp-t) 12 μg/0.5 ml; hepatitis b surface antigen 10 μg/0.5 ml; pertussis toxoid 25 μg/0.5 ml; poliovirius (inactivated) type 1 (mahoney) 40 du/0.5 ml; poliovirus (inactivated) type 2 (mef-1) 8 du/0.5 ml; poliovirus (inactivated) type 3 (saukett) 32 du/0.5 ml; tetanus toxoid 10 lf (>= 40 iu)/0.5 ml

Nouvelle-Zélande - anglais - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 60 iu/ml; hepatitis b surface antigen, recombinant 20 µg/ml; pertactin 16 µg/ml; pertussis filamentous haemagglutinin 50 µg/ml; pertussis toxoid, adsorbed 50 µg/ml; tetanus toxoid 80 iu/ml - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 60 iu/ml hepatitis b surface antigen, recombinant 20 µg/ml pertactin 16 µg/ml pertussis filamentous haemagglutinin 50 µg/ml pertussis toxoid, adsorbed 50 µg/ml tetanus toxoid 80 iu/ml excipient: aluminium hydroxide aluminium phosphate phenoxyethanol polysorbate 80 sodium chloride water for injection

Arabie saoudite - anglais - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxo saudi arabia - diphtheria, tetanus, pertussis - powder and suspension for suspension for injection

Arabie saoudite - anglais - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxosmithkline (gsk) - diphtheria, tetanus, pertussis - powder and suspension for suspension for injection

Arabie saoudite - anglais - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxosmithkline (gsk) - diphtheria, hemophilus influenzae b, hepatitis b, pertussis, poliomyelitis, tetanus - powder and suspension for suspension for injection

Arabie saoudite - anglais - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxo saudi arabia, saudi arabia - hepatitis b virus hbsag surface antigen,diphtheria toxoid,tetanus toxoid,pertussis toxoid,inactivated polio virus (ipv) type 1,inactivated polio virus (ipv) type 3,haemophilus influenzae type b,inactivated polio virus (ipv) type 2 - powder and suspension for suspension for injection - 10,30,40,25,40,32,10,8 iu, µg, da

Israël - anglais - Ministry of Health

pfizer pharmaceuticals israel ltd - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 18c; pneumococcal polysaccharide serotype 19 f; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 3; pneumococcal polysaccharide serotype 4; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 9v - suspension for injection - pneumococcal polysaccharide serotype 23f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19 f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 14 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 9v 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 7f 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6b 4.4 mcg / 0.5 ml; pneumococcal polysaccharide serotype 5 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 4 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 1 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 3 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 6a 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 18c 2.2 mcg / 0.5 ml; pneumococcal polysaccharide serotype 19a 2.2 mcg / 0.5 ml - pneumococcus, purified polysaccharides antigen conjugated - pneumococcus, purified polysaccharides antigen conjugated - active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in adults ≥18 years of age and the elderly

Canada - anglais - 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

États-Unis - anglais - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), 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) - clostridium tetani toxoid antigen (formaldehyde inactivated) 10 [iu] in 0.5 ml - infanrix is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday). severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to any component of infanrix is a contraindication [see description (11)] . because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is being considered. 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 infanrix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including infanrix. pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized. safety and effectiveness of infanrix in infants aged younger than 6 weeks and children aged 7 to 16 years have not been established. infanrix is not approved for use in these age groups.

Malaisie - anglais - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmaniaga lifescience sdn. bhd. - pneumococcal polysaccharide serotype 1; pneumococcal polysaccharide serotype 5; pneumococcal polysaccharide serotype 9v; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 19a; pneumococcal polysaccharide serotype 19f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 7f; pneumococcal polysaccharide serotype 6a; pneumococcal polysaccharide serotype 6b -