États-Unis - anglais - NLM (National Library of Medicine)

a-s medication solutions - streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen (unii: 54ec0se5pz) (streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen - unii:54ec0se5pz), streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen (unii: 2vf3v7175u) (streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen - unii:2vf3v7175u), streptococcus pneumoniae type - streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen 2.2 ug in 0.5 ml - in children 6 weeks through 5 years of age (prior to the 6th birthday), prevnar 13® is indicated for: in children 6 years through 17 years of age (prior to the 18th birthday), prevnar 13 is indicated for: risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data on prevnar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study has been performed in female rabbits administered prevnar 13 prior to mating and during gestation. each dose was approximately 20 times the human dose. this study revealed no evidence of harm to the fetus due to prevnar 13 (see 8.1 data). data animal in a developmental toxicity study, female rabbits were administered prevnar 13 by intramuscular injection twice prior to mating (17 days an

Canada - anglais - Health Canada

glaxosmithkline inc - pneumococcal polysaccharide serotype 1 conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 4 conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 5 conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 6b conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 7f conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 9v conjugated to protein d carrier protein; pneumococcal polysaccharide serotype 14 conjugated to protein d carrier protein; pneumococcal polysacc. serot. 18c conjug. to tetanus toxoid carrier prot.; pneumococcal polysaccharid serot. 19f conjug. to diphtheria toxoid carrier prot.; pneumococcal polysaccharide serotype 23f conjugated to protein d carrier protein - suspension - 1mcg; 3mcg; 1mcg; 1mcg; 1mcg; 1mcg; 1mcg; 3mcg; 3mcg; 1mcg - pneumococcal polysaccharide serotype 1 conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 4 conjugated to protein d carrier protein 3mcg; pneumococcal polysaccharide serotype 5 conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 6b conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 7f conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 9v conjugated to protein d carrier protein 1mcg; pneumococcal polysaccharide serotype 14 conjugated to protein d carrier protein 1mcg; pneumococcal polysacc. serot. 18c conjug. to tetanus toxoid carrier prot. 3mcg; pneumococcal polysaccharid serot. 19f conjug. to diphtheria toxoid carrier prot. 3mcg; pneumococcal polysaccharide serotype 23f conjugated to protein d carrier protein 1mcg - vaccines

Singapour - anglais - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - diphtheria toxoid protein; meningococcal (serogroup a) polysaccharide (monovalent conjugate); meningococcal (serogroup c) polysaccharide (monovalent conjugate); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate); meningococcal (serogroup y) polysaccharide (monovalent conjugate) - injection, solution - 48 microgram (diptheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio) - diphtheria toxoid protein 48 mcg/dose (0.5 ml) (diphtheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio); meningococcal (serogroup a) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup c) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup y) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml)

Canada - anglais - Health Canada

pfizer canada ulc - pneumococcal polysaccharide serotype 4; pneumococcal polysaccharide serotype 9v; pneumococcal polysaccharide serotype 14; pneumococcal polysaccharide serotype 18c; pneumococcal polysaccharide serotype 19f; pneumococcal polysaccharide serotype 23f; pneumococcal polysaccharide serotype 6b; corynebacterium diphtheriae crm-197 protein - suspension - 2mcg; 2mcg; 2mcg; 2mcg; 2mcg; 2mcg; 4mcg; 20mcg - pneumococcal polysaccharide serotype 4 2mcg; pneumococcal polysaccharide serotype 9v 2mcg; pneumococcal polysaccharide serotype 14 2mcg; pneumococcal polysaccharide serotype 18c 2mcg; pneumococcal polysaccharide serotype 19f 2mcg; pneumococcal polysaccharide serotype 23f 2mcg; pneumococcal polysaccharide serotype 6b 4mcg; corynebacterium diphtheriae crm-197 protein 20mcg - vaccines

Israël - anglais - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); haemophilus b; hepatitis b vaccines; pertactin; pertussis toxoid (pt); poliovirus type 1 inactivated; poliovirus type 2 inactivated; poliovirus type 3 inactivated; tetanus toxoid - powder and suspension for suspension for injection - filamentous haemagglutinin (fha) 25 mcg/dose; diphtheria toxoid nlt 30 iu/dose; tetanus toxoid nlt 40 iu/dose; hepatitis b vaccines 10 mcg/dose; poliovirus type 1 inactivated 40 du/dose; poliovirus type 2 inactivated 8 du/dose; poliovirus type 3 inactivated 32 du/dose; haemophilus b 10 mcg/dose; pertactin 8 mcg/dose; pertussis toxoid (pt) 25 mcg/dose - bacterial and viral vaccines, combined - infantix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenza type b for infants between 6 weeks and 36 months of age.

Union européenne - anglais - 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.

Union européenne - anglais - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis b surface antigen, poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenzae type-b.

Nouvelle-Zélande - anglais - 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

États-Unis - anglais - NLM (National Library of Medicine)

sanofi pasteur inc. - salmonella typhi ty2 vi polysaccharide antigen (unii: 7194h8w3kt) (salmonella typhi ty2 vi polysaccharide antigen - unii:7194h8w3kt) - salmonella typhi ty2 vi polysaccharide antigen 25 ug in 0.5 ml - typhim vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by s typhi and is approved for use in persons two years of age or older. immunization with typhim vi vaccine should occur at least two weeks prior to expected exposure to s typhi . typhim vi vaccine is not indicated for routine immunization of individuals in the united states (us). (14) selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with s typhi . (14) typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as africa, asia, and central and south america where there is a recognized r

États-Unis - anglais - NLM (National Library of Medicine)

sanofi pasteur inc. - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen (unii: flv5i5w26r) (haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen - unii:flv5i5w26r) - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - acthib® is a vaccine indicated for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. acthib is approved for use in children 2 months through 5 years of age. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any h. influenzae type b or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of acthib vaccine [see description (11)] . acthib is not approved for use in individuals 6 years of age and older. no human or animal data are available to assess vaccine-associated risks in pregnancy. acthib is not approved for use in individuals 6 years of age and older. human or animal data are not available to assess the impact of acthib on milk production, its presence in breast milk, or its effects on the breastfed infant. safety and effectiveness of acthib have not been established in infants below the age of 6 weeks and children and adolescents 6 years of age and older [see dosage and administration (2.1)] .