New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - diphtheria toxoid, adsorbed 2 [iu] (nlt); pertussis toxoid, adsorbed 20ug; tetanus toxoid, adsorbed 20 [iu] (nlt) - suspension for injection - active: diphtheria toxoid, adsorbed 2 [iu] (nlt) pertussis toxoid, adsorbed 20ug tetanus toxoid, adsorbed 20 [iu] (nlt) excipient: aluminium as aluminium hydroxide sodium chloride sodium hydroxide water for injection - for booster vaccination against tetanus, diphtheria and pertussis of individuals from the age of 4 years and onwards.

Canada - English - Health Canada

iaf biovac inc. - diphtheria toxoid; tetanus toxoid - suspension - 2lf; 5lf - diphtheria toxoid 2lf; tetanus toxoid 5lf - toxoids

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

sanofi-aventis australia pty ltd - diphtheria toxoid, quantity: 48 microgram; meningococcal polysaccharide group y, quantity: 4 microgram; meningococcal polysaccharide group w135, quantity: 4 microgram; meningococcal polysaccharide group c, quantity: 4 microgram; meningococcal polysaccharide group a, quantity: 4 microgram - injection, solution - excipient ingredients: monobasic sodium phosphate; sodium chloride; dibasic sodium phosphate - menactra is indicated for active immunisation of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by n meningitidis serogroups a, c, y and w-135.,menactra is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by n meningitidis serogroup b.,menactra is not indicated for treatment of meningococcal infections.,menactra is not indicated for immunisation against diphtheria.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sm pharmaceuticals sdn. bhd. - diphtheria toxoid; tetanus toxoid -

Malta - English - Medicines Authority

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

Canada - English - Health Canada

sanofi pasteur limited - filamentous haemagglutinin; pertussis toxoid; pertactin; diphtheria toxoid; tetanus toxoid; fimbriae types 2 and 3 (fim) - suspension - 5mcg; 2.5mcg; 3mcg; 2lf; 5lf; 5mcg - filamentous haemagglutinin 5mcg; pertussis toxoid 2.5mcg; pertactin 3mcg; diphtheria toxoid 2lf; tetanus toxoid 5lf; fimbriae types 2 and 3 (fim) 5mcg - toxoids

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 - 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

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 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.

Israel - English - Ministry of Health

medici medical ltd, israel - diphtheria toxoid; filamentous haemagglutinin (fha); fimbrae tupes 2 + 3 (fim); pertactin; pertussis acellular; tetanus toxoid - suspension for injection - pertussis acellular 10 mcg / 0.5 ml; filamentous haemagglutinin (fha) 5 mcg / 0.5 ml; fimbrae tupes 2 + 3 (fim) 5 mcg / 0.5 ml; pertactin 3 mcg / 0.5 ml; diphtheria toxoid 30 iu / 0.5 ml; tetanus toxoid 40 iu / 0.5 ml - pertussis, purified antigen, combinations with toxoids - pertussis, purified antigen, combinations with toxoids - is indicated for the primary immunization of infants at or above the age of 2 months and as a booster in children up to their 6th birthday against diphtheria, tetanus and pertussis.

Israel - English - 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.