Malta - angličtina - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection in pre-filled syringe - pertactin 8 µg pertussis toxoid 25 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu diphtheria toxoid filamentous haemagglutinin (fha) 25 µg tetanus toxoid - vaccines

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - pertussis toxoid; filamentous haemagglutinin; pertactin; diphtheria toxoid; tetanus toxoid; polio virus type 1 inactivated; polio virus type 2 inactivated; polio virus type 3 inactivated - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - diphtheria-pertussis-poliomyelitis-tetanus

Austrálie - angličtina - 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.

Austrálie - angličtina - 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.

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 60 iu/ml; pertactin 16 µg/ml;  ; pertussis filamentous haemagglutinin 50 µg/ml;  ; pertussis toxoid, adsorbed 50 µg/ml;  ; polio virus type 1 80 dagu/ml;  ; polio virus type 2 16 dagu/ml;  ; polio virus type 3 64 dagu/ml;  ; tetanus toxoid, adsorbed 80 iu/ml - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 60 iu/ml pertactin 16 µg/ml   pertussis filamentous haemagglutinin 50 µg/ml   pertussis toxoid, adsorbed 50 µg/ml   polio virus type 1 80 dagu/ml   polio virus type 2 16 dagu/ml   polio virus type 3 64 dagu/ml   tetanus toxoid, adsorbed 80 iu/ml excipient: aluminium hydroxide neomycin sulfate polymyxin b sulfate sodium chloride water for injection - infanrix®-ipv is indicated for active primary immunisation against diphtheria, tetanus, pertussis, and poliomyelitis. infanrix®-ipv is also indicated as a booster dose for children who have previously been immunised with dtp and polio antigens.

Velká Británie - angličtina - 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 - suspension for injection

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu] (not less than); 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] (not less than); haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (covalently bonded to tetanus toxoid 20 - 40micrograms);   - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] (not less than) 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] (not less than) excipient: aluminium medium 199 sodium chloride water for injection active: haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (covalently bonded to tetanus toxoid 20 - 40micrograms)   excipient: aluminium as aluminium phosphate lactose - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and haemophilus influenzae type b.

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu]; pertactin 8ug;  ; pertussis filamentous haemagglutinin 25ug;  ; pertussis toxoid, adsorbed 25ug;  ; tetanus toxoid, adsorbed 40 [iu]; diphtheria toxoid, adsorbed 30 [iu]; pertactin 8ug; pertussis filamentous haemagglutinin 25ug; pertussis toxoid, adsorbed 25ug; tetanus toxoid, adsorbed 40 [iu] - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] pertactin 8ug   pertussis filamentous haemagglutinin 25ug   pertussis toxoid, adsorbed 25ug   tetanus toxoid, adsorbed 40 [iu] excipient: aluminium as aluminium hydroxide & phosphate sodium chloride water for injection active: diphtheria toxoid, adsorbed 30 [iu] pertactin 8ug pertussis filamentous haemagglutinin 25ug pertussis toxoid, adsorbed 25ug tetanus toxoid, adsorbed 40 [iu] excipient: aluminium as aluminium hydroxide & phosphate phenoxyethanol polysorbate 80 sodium chloride water for injection - infanrix (dtpa) is indicated for active primary immunisation against diptheria, tetanus and pertussis. infanrix is indicated as fourth and/or fifth dose for children from 15 months of age up to and including 6 years of age who have previously been immunised with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccine.

Izrael - angličtina - 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - tetanus toxoid, quantity: 20 microgram/ml; meningococcal polysaccharide group c, quantity: 20 microgram/ml - injection, suspension - excipient ingredients: sodium chloride; water for injections; aluminium hydroxide hydrate - neisvac-c vaccine is indicated for active immunisation of children from 8 weeks of age, adolescents and adults, for the prevention of invasive disease caused by neisseria meningitidis serogroup c.