Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - diphtheria toxoid tetanus toxoid pertussis toxoid filamentous haemagglutinin (fha) pertactin polio virus type 1 inactivated polio virus type 2 inactivated polio virus type 3 inactivated haemophilus influenzae type b capsular polysaccharide (prp) and tetanus toxoid tetanus vaccine adsorbed - %v/v

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

United States - English - 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.

United Kingdom - English - 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; haemophilus influenzae type b polysaccharide protein conjugate - powder and suspension for suspension for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - diphtheria toxoid, adsorbed 2 [iu] (nlt, equiv to 2 lf per dose); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 2.5ug; polio virus type 1 29 dagu (mahoney, by parallel line method (equiv to 40 dagu by sigmoid method)); polio virus type 2 7 dagu (mef 1, by parallel line method (equiv to 8 dagu by sigmoid method)); polio virus type 3 26 dagu (saukett, by parallel line method (equiv to 32 dagu by sigmoid method)); tetanus toxoid 20 [iu] (nlt, equiv to 5 lf per dose) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 2 [iu] (nlt, equiv to 2 lf per dose) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 2.5ug polio virus type 1 29 dagu (mahoney, by parallel line method (equiv to 40 dagu by sigmoid method)) polio virus type 2 7 dagu (mef 1, by parallel line method (equiv to 8 dagu by sigmoid method)) polio virus type 3 26 dagu (saukett, by parallel line method (equiv to 32 dagu by sigmoid method)) tetanus toxoid 20 [iu] (nlt, equiv to 5 lf per dose) excipient: aluminium phosphate ethanol phenoxyethanol polysorbate 80 water for injection - adacel® polio is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation. children 4-6 years of age should have already received four doses of dtpa and ipv or opv. adacel® polio is not intended for primary immunisation. adacel® polio may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus. the use of adacel® polio should be determined on the basis of official recommendations.

Israel - English - Ministry of Health

sanofi israel ltd - diphtheria toxoid; filamentous haemagglutinin (fha); fimbrae tupes 2 + 3 (fim); inactivated polio virus (ipv) type 1; inactivated polio virus (ipv) type 2; inactivated polio virus (ipv) type 3; pertactin (prn); pertussis toxoid vaccine; tetanus toxoid - suspension for injection - fimbrae tupes 2 + 3 (fim) 5 mcg/dose; pertussis toxoid vaccine 2.5 mcg/dose; filamentous haemagglutinin (fha) 5 mcg/dose; pertactin (prn) 3 mcg/dose; diphtheria toxoid 2 lf / 1 doses; tetanus toxoid 5 lf / 1 doses; inactivated polio virus (ipv) type 1 40 du/dose; inactivated polio virus (ipv) type 2 8 du/dose; inactivated polio virus (ipv) type 3 32 du/dose - diphtheria-pertussis-poliomyelitis-tetanus - diphtheria-pertussis-poliomyelitis-tetanus - active immunization against diphtheria, tetanus, pertussis and poliomyelitis in subjects aged 4 years and over as a booster following primary immunisation.adacel polio is not indicated for primary immunisation. adacel polio is not indicated for treating diseases caused by b.pertussis, c.diphtheriae or c.tetani or by poliomyelitis infections

Ireland - English - 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 - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis filamentous, haemagglutinin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, haemophilus influenzae, type b, polysaccharide, polyribosylribitol phosphate, tetanus toxoid - powder and suspension for suspension for injection - pertactin 8 µg pertussis filamentous haemagglutinin 25 µg pertussis toxoid 25 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu/0.5ml poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu/0.5ml poliovirus (inactivated) type 3 (saukett strain) 32 dagu/0.5ml diphtheria toxoid haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg tetanus toxoid - vaccines

Malta - English - Medicines Authority

nm pharma limited 3/4, cantrija complex triq it-targa, il-maghtab naxxar nxr 6613 , malta - diphtheria toxoid, tetanus toxoid, pertussis toxoid, filamentous haemagglutinin, fha, pertactin, poliovirus, inactivated, type, mahoney strain, mef, saukett strain - suspension for injection in pre-filled syringe - diphtheria toxoid 2 iu poliovirus (inactivated) type 3 (saukett strain) 32 dagu pertactin 2.5 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu tetanus toxoid 20 iu pertussis toxoid 8 µg filamentous haemagglutinin (fha) 8 µg - vaccines

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); pertactin (prn or 69 kda omp); pertussis toxoid (pt); tetanus toxoid - suspension for injection - diphtheria toxoid nlt 2 iu / 0.5 ml; tetanus toxoid nlt 20 iu / 0.5 ml; filamentous haemagglutinin (fha) 8 mcg / 0.5 ml; pertussis toxoid (pt) 8 mcg / 0.5 ml; pertactin (prn or 69 kda omp) 2.5 mcg / 0.5 ml - tetanus toxoid, combinations with diphtheria toxoid - tetanus toxoid, combinations with diphtheria toxoid - for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards.the administration of boostrix should be based on official recommendations