Malta - angličtina - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - pertactin, pertussis toxoid, diphtheria toxoid, filamentous haemagglutinin, fha, fimbriae types, and, tetanus toxoid - suspension for injection - pertactin 3 µg pertussis toxoid 2.5 µg diphtheria toxoid filamentous haemagglutinin (fha) 5 µg fimbriae types 2 and 3 5 µg tetanus toxoid - vaccines

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

sanofi pasteur - purified diphtheria toxoid ph. eur.; purified tetanus toxoid; adsorbed purified pertussis toxoid; adsorbed purified filamentous haemagglutinin; inactivated poliomyelitis virus ph. eur; inactivated type 1 poliovirus; inactivated type 2 poliovirus; inactivated type 3 poliovirus; haemophilus influenzae type b, conjugate with tetanus protein - powder for suspension for injection - 0.5 millilitre(s) - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Velká Británie - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi - human poliovirus type 3 inactivated; human poliovirus type 2 inactivated; human poliovirus type 1 inactivated; tetanus toxoid; diphtheria toxoid - suspension for injection

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: polysorbate 80; aluminium; histidine; sodium chloride; borax; water for injections - gardasil 9 is indicated in females aged 9 to 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: sodium chloride; histidine; borax; aluminium; water for injections; polysorbate 80 - gardasil 9 is indicated in females aged 9 to 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

Spojené státy - angličtina - 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.

Spojené státy - angličtina - 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.

Singapur - angličtina - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - (acellular pertussis) filamentous haemagglutinin adsorbed (fha); (acellular pertussis) fimbriae type 2 and 3 adsorbed (fim); (acellular pertussis) pertactin adsorbed (prn); (acelullar pertussis) pertussis toxoid adsorbed (pt); diphtheria toxoid adsorbed; inactivated poliomyelitis vaccine (ipv) type 1 mahoney; inactivated poliomyelitis vaccine (ipv) type 2 (mef-1); inactivated poliomyelitis vaccine (ipv) type 3 (saukett); tetanus toxoid adsorbed - injection, suspension - (acellular pertussis) filamentous haemagglutinin adsorbed (fha) 5 µg/ 0.5 ml; (acellular pertussis) fimbriae type 2 and 3 adsorbed (fim) 5 µg/0.5 ml; (acellular pertussis) pertactin adsorbed (prn) 3 µg/0.5 ml; (acelullar pertussis) pertussis toxoid adsorbed (pt) 2.5 µg/ 0.5 ml; diphtheria toxoid adsorbed 2lf; inactivated poliomyelitis vaccine (ipv) type 1 mahoney 40 d-antigen units; inactivated poliomyelitis vaccine (ipv) type 2 (mef-1) 8 d-antigen units; inactivated poliomyelitis vaccine (ipv) type 3 (saukett) 32 d-antigen units; tetanus toxoid adsorbed 5lf

Keňa - angličtina - Pharmacy and Poisons Board

lg chem, ltd, e14 block lg science park, 70, magokjungang - inactivated poliovirus types 1, 2 and 3(sabin… - solution for injection - a single human dose (0.5 ml) of sabin inactivated… - poliomyelitis trivalent inactivated whole virus

Filipíny - angličtina - FDA (Food And Drug Administration)

n/a; importer: faberco life sciences inc.; distributor: faberco life sciences inc. - inactivated poliomyelitis vaccine (types 1, 2 and 3) - suspension for injection (im/sc) - 0.5 ml