Estados Unidos - inglés - 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

Filipinas - inglés - FDA (Food And Drug Administration)

n/a; importer: sanofi pasteur, inc.; distributor: n/a - inactivated poliomyelitis vaccine (type 1,2 and 3) - suspension for injection (im/sc) - formulation: one dose (0.5 ml) contains: poliovirus type 1, mahoney strain (inactivated)-40 d-antigen units poliovirus type 2, mff-i strain (inactivated)- 8 d-antigen units poliovirus type 3, saukett strain (inactivated) - 32 d-antigen units

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

sanofi-aventis australia pty ltd - poliovirus, quantity: 17 dagu; poliovirus, quantity: 20 dagu; poliovirus, quantity: 5 dagu - injection, suspension - excipient ingredients: sodium hydroxide; hydrochloric acid; formaldehyde solution; phenoxyethanol; glucose monohydrate; purified water; polysorbate 80; ascorbic acid; sodium chloride; aminobenzoic acid; adenosine phosphate; dl-alpha-tocopheryl phosphate disodium; magnesium sulfate; monobasic potassium phosphate; deoxyribose; calcium chloride dihydrate; iron trinitrate; potassium chloride; magnesium sulfate heptahydrate; potassium nitrate; sodium selenite; monobasic sodium phosphate; dibasic sodium phosphate heptahydrate; adenine sulfate; adenosine triphosphate disodium; cholesterol; glutathione; guanine hydrochloride; hypoxanthine; phenolsulfonphthalein; ribose; sodium acetate; thymine; uracil; xanthine; sodium pyruvate; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; hydroxyproline; isoleucine; asparagine; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; - ipol is indicated for active immunisation of infants, children and adults for the prevention of poliomyelitis. ipol should be offered to patients who have refused opv or in whom opv is contraindicated. ipol is also indicated for: 1) the primary vaccination of immunocompromised individuals of all ages, and household contacts of such individuals (when vaccination is indicated); (2) unvaccinated or inadequately vaccinated(*) adults, particularly if at increased risk of exposure to live polio virus, including: - travellers to areas or countries where poliomyelitis is epidemic or endemic: - laboratory workers handling specimens which may contain polio virus; - health care workers in close contact with patients who may be excreting polioviruses. (*) such as those who may not have completed a primary series of vaccination or not received a booster dose since infancy. idications as at 9 june 2003: ipol is indicated for active immunisation of infants, children and adults for the prevention of poliomyelitis. recommen

Malta - inglés - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - 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 2.5 µg pertussis toxoid 8 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) 8 µg tetanus toxoid - vaccines

Estados Unidos - inglés - 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 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), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), 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 - a single dose of kinrix is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (dtap) vaccine series and the fourth dose in the inactivated poliovirus vaccine (ipv) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous dtap vaccine doses have been with infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) and/or pediarix [diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine] for the first 3 doses and infanrix for the fourth dose. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis- or poliovirus-containing vaccine, or to any component of kinrix, including neomycin and polymyxin b, is a contraindication to administration of kinrix [see description (11)] . because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered. 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 kinrix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including kinrix. pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. safety and effectiveness of kinrix in children younger than 4 years and children aged 7 to 16 years have not been evaluated. kinrix is not approved for use in persons in these age groups.

Unión Europea - inglés - EMA (European Medicines Agency)

sanofi pasteur msd, snc - purified diphtheria toxoid, purified tetanus toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis b surface antigen, inactivated type 1 poliovirus (mahoney), inactivated type 2 poliovirus (mef 1), inactivated type 3 poliovirus (saukett), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - this combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis b caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by haemophilus influenzae type b.

Israel - inglés - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); inactivated polio virus (ipv) type 1; inactivated polio virus (ipv) type 2; inactivated polio virus (ipv) type 3; pertactin (prn or 69 kda omp); pertussis toxoid vaccine; tetanus toxoid - suspension for injection - pertactin (prn or 69 kda omp) 2.5 mcg / 0.5 ml; 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 vaccine 8 mcg / 0.5 ml; inactivated polio virus (ipv) type 3 32 du / 0.5 ml; inactivated polio virus (ipv) type 1 40 du / 0.5 ml; inactivated polio virus (ipv) type 2 8 du / 0.5 ml - bacterial and viral vaccines, combined - for booster vaccination against diphtheria, tetanus and pertusis and poliomyelitis of individuals from the age of three years onwards. the administration of boostrix polio should be based on official recommendations.

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

sanofi-aventis australia pty ltd - diphtheria toxoid,pertactin,pertussis filamentous haemagglutinin,pertussis fimbriae 2 + 3,pertussis toxoid,poliovirus,tetanus toxoid -

Bélgica - inglés - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

glaxosmithkline biologicals sa-nv - poliovirus type 2 (inactivated) 8 d-antigen u/1 dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; poliovirus type 1 (inactivated) 40 d-antigen u/1 dose; bordetella pertussis pertactin 8 µg/dose; tetanus toxoid >= 40 iu/dose; bordetella pertussis filamentous hemagglutinin (fha) 25 µg/dose; bordetella pertussis toxoid (pt) 25 µg/dose; diphtheria toxoid (dt) >= 30 iu/dose; conjugate of haemophilus influenzae type b capsular polysaccharide and tetanus toxoid - powder and solvent for suspension for injection - diphteria antigen, adsorbed; haemophilus influenzae type b polysaccharides, conjugated to tetanus toxoid; poliomyelitis virus; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Bélgica - inglés - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sanofi pasteur europe s.a. - poliovirus type 1 (inactivated) 40 d-antigen u/1 dose; bordetella pertussis toxoid (pt) 25 µg/dose; conjugate of haemophilus influenzae type b capsular polysaccharide and tetanus toxoid 10 µg/dose; bordetella pertussis filamentous hemagglutinin (fha) 25 µg/dose; tetanus toxoid >= 40 iu/dose; poliovirus type 3 (inactivated) 32 d-antigen u/1 dose; diphtheria toxoid (dt) >= 30 iu/dose; poliovirus type 2 (inactivated) 8 d-antigen u/1 dose - powder and suspension for suspension for injection - diphteria antigen, adsorbed; haemophilus influenzae type b polysaccharides, conjugated to tetanus toxoid; poliomyelitis virus; tetanus toxoid adsorbed; bordetella pertussis antigen, proteins - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus