Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 2 [iu] (lower fiducial limit); pertactin 2.5ug; pertussis filamentous haemagglutinin 8ug; pertussis toxoid, adsorbed 8ug; tetanus toxoid, adsorbed 20 [iu] (lower fiducial limit); diphtheria toxoid, adsorbed 2 [iu] (lower fiducial limit); pertactin 2.5ug; pertussis filamentous haemagglutinin 8ug; pertussis toxoid, adsorbed 8ug; tetanus toxoid, adsorbed 20 [iu] (lower fiducial limit) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] (lower fiducial limit) pertactin 2.5ug pertussis filamentous haemagglutinin 8ug pertussis toxoid, adsorbed 8ug tetanus toxoid, adsorbed 20 [iu] (lower fiducial limit) excipient: aluminium hydroxide aluminium phosphate formaldehyde glycine phenoxyethanol polysorbate 80 sodium chloride water for injection active: diphtheria toxoid, adsorbed 2 [iu] (lower fiducial limit) pertactin 2.5ug pertussis filamentous haemagglutinin 8ug pertussis toxoid, adsorbed 8ug tetanus toxoid, adsorbed 20 [iu] (lower fiducial limit) excipient: aluminium hydroxide aluminium phosphate sodium chloride water for injection - boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older.

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - pneumococcal polysaccharide serotype 14 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 18c 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 19f 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 23f 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 4 2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 6b 4ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 9v 2ug (conjugated with diphtheria crm 197 protein) - suspension for injection - 0.5 ml - active: pneumococcal polysaccharide serotype 14 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 18c 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 19f 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 23f 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 4 2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 6b 4ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 9v 2ug (conjugated with diphtheria crm 197 protein) excipient: aluminium phosphate sodium chloride water for injection

Israel - inglês - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); pertactin; pertussis toxoid (pt); tetanus toxoid - suspension for injection - diphtheria toxoid nlt 30 iu; tetanus toxoid nlt 40 iu; pertactin 8 mcg / 0.5 ml; filamentous haemagglutinin (fha) 25 mcg / 0.5 ml; pertussis toxoid (pt) 25 mcg / 0.5 ml - bacterial and viral vaccines, combined - infanrix is indicated as a booster dose for children 15 months to 7 years of age who have previously been immunised with three or four doses of either dtpa vaccine or diphtheria, tetanus and whole-cell pertussis (dtpw) vaccine. active primary immunisation against diphteria, tetanus and pertussis from the age 2 months onward.

Estados Unidos - inglês - 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.

Nova Zelândia - inglês - 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

Israel - inglês - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), 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), hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p), poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 25 [iu] in 0.5 ml - pediarix is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis b virus, and poliomyelitis. pediarix is approved for use as a 3-dose series in infants born of hepatitis b surface antigen (hbsag)-negative mothers. pediarix may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday). a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis b-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin b, is a contraindication to administration of pediarix [see description (11)] . 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 pediarix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including pediarix. pediarix should not be administered to individuals with such conditions until the neurologic status is clarified and stabilized. safety and effectiveness of pediarix were established in the age group 6 weeks through 6 months on the basis of clinical studies [see adverse reactions (6.1), clinical studies (14.1, 14.2)] . safety and effectiveness of pediarix in the age group 7 months through 6 years are supported by evidence in infants aged 6 weeks through 6 months. safety and effectiveness of pediarix in infants younger than 6 weeks and children aged 7 to 16 years have not been evaluated.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

tetanus toxoid; diphtheria toxoid; polyribose ribitol phosphate - haemophilus influenzae type b; poliovirus; pertactin; pertussis toxoid; hepatitis b surface antigen recombinant; pertussis filamentous haemagglutinin -

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin; pertactin; pertussis toxoid; tetanus toxoid; poliovirus; diphtheria toxoid -

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin; poliovirus; tetanus toxoid; pertactin; pertussis toxoid; hepatitis b surface antigen recombinant; polyribose ribitol phosphate - haemophilus influenzae type b; diphtheria toxoid -