United States - English - 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 - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 15 [lf] in 0.5 ml - pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to haemophilus influenzae type b. pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday). a severe allergic reaction (eg, anaphylaxis) after a previous dose of pentacel or any other diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, inactivated poliovirus vaccine or h. influenzae type b vaccine, or any ingredient of this vaccine is a contraindication to administration of pentacel. [see description (11). ] encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days 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 pentacel. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progres

Australia - English - 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 - English - 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

New Zealand - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - pneumococcal polysaccharide serotype 1 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 14 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 18c 3ug (conjugated with tetanus toxoid);  ;  ; pneumococcal polysaccharide serotype 19f 3ug (conjugated with diptheria toxoid);  ;  ; pneumococcal polysaccharide serotype 23f 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 4 3ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 5 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 6b 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 7f 1ug (conjugated with nthi protein d);  ;  ; pneumococcal polysaccharide serotype 9v 1ug (conjugated with nthi protein d);  ;   - suspension for injection - active: pneumococcal polysaccharide serotype 1 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 14 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 18c 3ug (conjugated with tetanus toxoid)     pneumococcal polysaccharide serotype 19f 3ug (conjugated with diptheria toxoid)     pneumococcal polysaccharide serotype 23f 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 4 3ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 5 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 6b 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 7f 1ug (conjugated with nthi protein d)     pneumococcal polysaccharide serotype 9v 1ug (conjugated with nthi protein d)     excipient: aluminium phosphate diphtheria toxoid, adsorbed haemophilus influenzae protein d sodium chloride tetanus toxoid water for injection - synflorix is indicated for the active immunisation of infants and children from the age of 6 weeks up to 5 years against disease caused by streptococcus pneumoniae vaccine serotypes 1, 4, 5, 6b, 7f, 9v, 14, 18c, 19f, 23f and cross-reactive serotype 19a (including invasive disease, pneumonia and acute otitis media).

Ireland - English - 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

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - vaccines - active immunisation against invasive disease and acute otitis media caused by streptococcus pneumoniae in infants and children from six weeks up to five years of age. see sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes.the use of synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.

New Zealand - English - 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

Ireland - English - 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 - %v/v

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - human-bovine rotavirus g1; human-bovine rotavirus g2; human-bovine rotavirus g3; human-bovine rotavirus g4; human-bovine rotavirus p1 - solution - 2.2 x exponential 6 infectious units - human-bovine rotavirus g1 2.2 x exponential 6 infectious units; human-bovine rotavirus g2 2.8 x exponential 6 infectious units; human-bovine rotavirus g3 2.2 x exponential 6 infectious units; human-bovine rotavirus g4 2.0 x exponential 6 infectious units; human-bovine rotavirus p1 2.3 x exponential 6 infectious units