Australien - engelsk - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - 45156 - medicine administration kit, percutaneous, medicated, single-use - adacel polio procedure pack contains a syringe pre-filled with a single dose of vaccine (pertussis vaccine - acellular diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus type 1,2 and 3 (vero cell)) and two separate needles of varying size. these separate needles are supplied to enable the vaccinator to choose the appropriate needle size for the injection of vaccine to the vaccinee. this is a single-use only product.

New Zealand - engelsk - 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.

Irland - engelsk - 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

Malta - engelsk - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, fimbriae types, and, haemophilus influenzae, type b, polysaccharide, polyribosylribitol phosphate, tetanus toxoid - suspension for injection in pre-filled syringe - pertactin 3 µg pertussis toxoid 20 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) 20 µg fimbriae types 2 and 3 5 µg haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg tetanus toxoid - vaccines

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - tetanus toxoid, quantity: 40 iu; pertussis fimbriae 2 + 3, quantity: 5 microgram; diphtheria toxoid, quantity: 30 iu; poliovirus, quantity: 29 dagu; poliovirus, quantity: 26 dagu; poliovirus, quantity: 7 dagu; pertussis toxoid, quantity: 20 microgram; pertactin, quantity: 3 microgram; pertussis filamentous haemagglutinin, quantity: 20 microgram - injection, suspension - excipient ingredients: polymyxin b sulfate; bovine serum albumin; formaldehyde; phenoxyethanol; glutaral; neomycin; water for injections; polysorbate 80; aluminium phosphate - quadracel is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis, and poliomyelitis.,quadracel is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

Malta - engelsk - Medicines Authority

bilthoven biologicals b.v. antonie van leeuwenhoeklaan 9 3721 ma, bilthoven, netherlands - suspension for injection - diphtheria toxoid >5 iu poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 4 dagu poliovirus (inactivated) type 3 (saukett strain) 7.5 dagu tetanus toxoid >20 iu - vaccines

USA - engelsk - NLM (National Library of Medicine)

sanofi pasteur inc. - 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 (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. a single dose of quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (dtap) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (ipv) vaccination series in children 4 through 6 years of age whose previous dtap vaccine doses have been with pentacel® [diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine], daptacel® (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) and/or vaxelis (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine). severe allergic reaction (e.g., anaphylaxis) to any ingredient of quadracel [see description (11) ] or following any diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovi

New Zealand - engelsk - 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.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - tetanus toxoid, diphtheria toxoid, pertussis toxoid, filamentous haemagglutinin (fha), pertactin, polio virus type 1 inactivated, polio virus type 2 inactivated, polio virus type 3 inactivated, adsorbed fimbriae types 2 + 3 - suspension for injection - unknown - bacterial and viral vaccines, combined

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - neisseria meningitidis group a polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid);  ; neisseria meningitidis group c polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid);  ; neisseria meningitidis group w135 polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 7.5 mcg of tetanus toxoid);  ; neisseria meningitidis group y polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 6.5 mcg of tetanus toxoid);   - powder for injection with diluent - active: neisseria meningitidis group a polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid)   neisseria meningitidis group c polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 15 mcg of tetanus toxoid)   neisseria meningitidis group w135 polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 7.5 mcg of tetanus toxoid)   neisseria meningitidis group y polysaccharide, tetanus toxoid conjugate 5ug (5 mcg polysaccharide conjugated to approx 6.5 mcg of tetanus toxoid)   excipient: sucrose tetanus toxoid trometamol hydrochloride sodium chloride water for injection - nimenrix is indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal disease caused by neisseria meningitidis groups a, c, w-135 and y