Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); haemophilus b; hepatitis b vaccines; pertactin; pertussis toxoid (pt); poliovirus type 1 inactivated; poliovirus type 2 inactivated; poliovirus type 3 inactivated; tetanus toxoid - powder and suspension for suspension for injection - filamentous haemagglutinin (fha) 25 mcg/dose; diphtheria toxoid nlt 30 iu/dose; tetanus toxoid nlt 40 iu/dose; hepatitis b vaccines 10 mcg/dose; poliovirus type 1 inactivated 40 du/dose; poliovirus type 2 inactivated 8 du/dose; poliovirus type 3 inactivated 32 du/dose; haemophilus b 10 mcg/dose; pertactin 8 mcg/dose; pertussis toxoid (pt) 25 mcg/dose - bacterial and viral vaccines, combined - infantix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenza type b for infants between 6 weeks and 36 months of age.

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

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

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

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; tetanus toxoid, quantity: 20 lfu/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - tetanus toxoid; pertussis antigens; human poliovirus type 3 inactivated; human poliovirus type 2 inactivated; human poliovirus type 1 inactivated; hepatitis b virus surface antigen; haemophilus influenzae type b polysaccharide protein conjugate; diphtheria toxoid - powder and suspension for suspension for injection

European Union - English - EMA (European Medicines Agency)

sanofi pasteur - hepatitis b surface antigen, diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens pertussis toxoid filamentous haemagglutinin, poliovirus (inactivated) type 1 (mahoney) type 2 (mef-1) type 3 (saukett), haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines, bacterial and viral vaccines, combined - hexacima (dtap-ipv-hb-hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib).the use of this vaccine should be in accordance with official recommendations.

European Union - English - EMA (European Medicines Agency)

sanofi pasteur europe - filamentous haemagglutinin, haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate), hepatitis b surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (mahoney strain) produced on vero cells, poliovirus (inactivated) type 2 (mef-1 strain) produced on vero cells, poliovirus (inactivated) type 3 (saukett strain) produced on vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, diphtheria toxoid - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - hexyon (dtap-ipv-hb-hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive diseases caused by haemophilus influenzae type b (hib).the use of this vaccine should be in accordance with official recommendations.

Canada - English - Health Canada

glaxosmithkline inc - pertussis toxoid; filamentous haemagglutinin; pertactin; diphtheria toxoid; tetanus toxoid; inactivated poliovirus type i; inactivated poliovirus type ii; inactivated poliovirus type iii; haemophilus influenzae type b-prp and tetanus toxoid conjugate (prp-t) - suspension - 25mcg; 25mcg; 8mcg; 30unit; 40unit; 40unit; 8unit; 32unit; 10mcg - pertussis toxoid 25mcg; filamentous haemagglutinin 25mcg; pertactin 8mcg; diphtheria toxoid 30unit; tetanus toxoid 40unit; inactivated poliovirus type i 40unit; inactivated poliovirus type ii 8unit; inactivated poliovirus type iii 32unit; haemophilus influenzae type b-prp and tetanus toxoid conjugate (prp-t) 10mcg - vaccines

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 2 [iu] (2.5lfu); pertactin 2.5ug;  ; pertussis filamentous haemagglutinin 8ug;  ; pertussis toxoid, adsorbed 8ug;  ; polio virus type 1 40 dagu;  ; polio virus type 2 8 dagu;  ; polio virus type 3 32 dagu;  ; tetanus toxoid 20 [iu] (5lfu) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] (2.5lfu) pertactin 2.5ug   pertussis filamentous haemagglutinin 8ug   pertussis toxoid, adsorbed 8ug   polio virus type 1 40 dagu   polio virus type 2 8 dagu   polio virus type 3 32 dagu   tetanus toxoid 20 [iu] (5lfu) excipient: aluminium medium 199 sodium chloride water for injection - boostrix®-ipv is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of four years onwards. boostrix®-ipv is not intended for primary immunisation.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - pneumococcal polysaccharide serotype 1 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 14 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 18c 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 19a 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 19f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 23f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 3 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 4 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 5 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 6a 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 6b 4.4ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 7f 2.2ug (conjugated with diphtheria crm 197 protein); pneumococcal polysaccharide serotype 9v 2.2ug (conjugated with diphtheria crm 197 protein) - suspension for injection - 0.5 ml - active: pneumococcal polysaccharide serotype 1 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 14 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 18c 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 19a 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 19f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 23f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 3 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 4 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 5 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 6a 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 6b 4.4ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 7f 2.2ug (conjugated with diphtheria crm 197 protein) pneumococcal polysaccharide serotype 9v 2.2ug (conjugated with diphtheria crm 197 protein) excipient: aluminium phosphate polysorbate 80 sodium chloride succinic acid water for injection - active immunisation for the prevention of pneumococcal disease caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f and 23f in adults and children aged more than 6 weeks of age. the use of prevenar 13 should be guided by official recommendations.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu]; hepatitis b surface antigen, recombinant 10ug; pertactin 8ug;  ; pertussis filamentous haemagglutinin 25ug;  ; pertussis toxoid, adsorbed 25ug;  ; polio virus type 1 40 dagu (/dose);  ; polio virus type 2 8 dagu (/dose);  ; polio virus type 3 32 dagu (/dose);  ; tetanus toxoid, adsorbed 40 [iu] - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] hepatitis b surface antigen, recombinant 10ug pertactin 8ug   pertussis filamentous haemagglutinin 25ug   pertussis toxoid, adsorbed 25ug   polio virus type 1 40 dagu (/dose)   polio virus type 2 8 dagu (/dose)   polio virus type 3 32 dagu (/dose)   tetanus toxoid, adsorbed 40 [iu] excipient: aluminium hydroxide aluminium phosphate formaldehyde glycine medium 199 monobasic potassium phosphate neomycin sulfate polymyxin b sulfate polysorbate 20 potassium chloride sodium chloride sodium phosphate (32p) water for injection - infanrix®-penta is indicated for immunisation against diphtheria, tetanus, pertussis, hepatitis b and poliomyelitis in infants from the age of 6 weeks and may also be given to infants who received a first dose of hepatitis b vaccine at birth.