New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - diphtheria toxoid, adsorbed 30 [iu] - solution for injection - 30 iu/0.5ml - active: diphtheria toxoid, adsorbed 30 [iu] excipient: aluminium phosphate dibasic sodium phosphate dodecahydrate monobasic sodium phosphate monohydrate sodium chloride thiomersal

European Union - English - EMA (European Medicines Agency)

gsk vaccines s.r.l. - meningococcal group a, c, w-135 and y conjugate vaccine - immunization, meningitis, meningococcal - bacterial vaccines - prefilled syringe menveo is indicated for active immunisation of adolescents (from 11 years of age) and adults at risk of exposure to neisseria meningitidis groups a, c, w135 and y, to prevent invasive disease. the use of this vaccine should be in accordance with official recommendations. vials menveo is indicated for active immunisation of children (from two years of age), adolescents and adults at risk of exposure to neisseria meningitidis groups a, c, w135 and y, to prevent invasive disease. the use of this vaccine should be in accordance with official recommendations.,

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, inactivated bordetella pertussis, hepatitis b surface antigen (rdna), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; diphtheria - vaccines - quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis b and invasive disease caused by haemophilus influenzae type b and for booster immunisation of young children during the second year of life.the use of quintanrix should be determined on the basis of official recommendations.

United States - English - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen (unii: 3o44u6xyqk) (neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen - unii:3o44u6xyqk) - neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen 10 ug in 0.5 ml - menveo is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, y, and w-135 in individuals 2 months through 55 years of age. menveo does not prevent n. meningitidis serogroup b infections. do not administer menveo to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of menveo, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine. [see description (11).] risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. 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. there are no adequate and well-controlled studies of menveo in pregnant women in the u.s. there was a pregnancy exposure registry conducted from 2014-2017 that included 82 subjects. available data do not suggest an increased risk of major birth defects and miscarriage in women who received menveo within 28 days prior to conception or during pregnancy (see data) . a developmental toxicity study was performed in female rabbits administered 0.5 ml (at each occasion) of menveo prior to mating and during gestation. a single human dose is 0.5 ml. this study revealed no adverse effects on fetal or pre-weaning development (see data) . data human data: a pregnancy exposure registry (2014 to 2017) included 82 pregnancies with known outcomes with exposure within 28 days prior to conception or during pregnancy. miscarriage was reported for 12.2% of pregnancies with exposure to menveo within 28 days prior to conception or during pregnancy (10/82). major birth defects were reported for 3.6% of live born infants whose mothers were exposed within 28 days prior to conception or during pregnancy (2/55). the rates of miscarriage and major birth defects were consistent with estimated background rates. animal data: in a developmental toxicity study, female rabbits were administered menveo by intramuscular injection on days 29, 15, and 1 prior to mating and on gestation days 7 and 20. the total dose was 0.5 ml at each occasion (a single human dose is 0.5 ml). no adverse effects on pre-weaning development up to postnatal day 29 were observed. there were no vaccine-related fetal malformations or variations observed. risk summary it is not known whether the vaccine components of menveo are excreted in human milk. data are not available to assess the effects of menveo in the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for menveo and any potential adverse effects on the breastfed child from menveo or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of menveo in children aged younger than 2 months have not been established. safety and effectiveness of the one-vial presentation of menveo in children aged younger than 10 years have not been established. [see dosage and administration (2).] for children 2 months through 9 years of age, only the two-vial presentation is approved for use. [see dosage and administration (2).] safety and effectiveness of menveo in adults aged 65 years and older have not been established.

Malta - English - Medicines Authority

ibss biomed s.a. al. sosnowa 8, 30-224 krakow, poland - diphtheria toxoid, tetanus toxoid - suspension for injection - diphtheria toxoid 5 iu tetanus toxoid 40 iu - vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - diphtheria toxoid; tetanus toxoid; poliovirus, type 1; poliovirus, type 2; poliovirus, type 3 - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - bacterial and viral vaccines, combined; diphtheria-poliomyelitis-tetanus

Ireland - English - HPRA (Health Products Regulatory Authority)

aj vaccines a/s - diphtheria toxoid, purified; tetanus toxoid, purified; pertussis toxoid, purified - suspension for injection in pre-filled syringe - < 2 international unit(s) - pertussis vaccines; pertussis, purified antigen, combinations with toxoids

Malta - English - 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

Malta - English - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis toxoid, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection - pertactin 2.5 µg pertussis toxoid 8 µg diphtheria toxoid filamentous haemagglutinin (fha) 8 µg tetanus toxoid - vaccines

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - tetanus toxoid, diphtheria toxoid, haemophilus type, b polysaccharide, polyribosylribitol phosphate, conjugated to, as carrier, protein, bordetella pertussis - powder and suspension for suspension for injection - diphtheria toxoid haemophilus type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus toxoid as carrier protein 10 µg bordetella pertussis 4 iu tetanus toxoid 60 iu - vaccines