Saudiarabien - engelska - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sanofi pasteur, united states - meningococcal group a (neisseria meningitidis) polysaccharide vaccine,meningococcal group c (neisseria meningitidis) polysaccharide,meningococcal group w (neisseria meningitidis) polysaccharide,meningococcal group y (neisseria meningitidis) polysaccharide,diphtheria toxoid - solution for injection - 4,4,4,4,48 µg,

USA - engelska - 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.

Europeiska unionen - engelska - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid - meningitis, meningococcal - vaccines - nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by neisseria meningitidis group a, c, w-135, and y.

Kanada - engelska - Health Canada

glaxosmithkline inc - meningococcal polysaccharide antigen group a; meningococcal polysaccharide antigen group c; sodium chloride - powder for solution - 50mcg; 50mcg; .5ml - meningococcal polysaccharide antigen group a 50mcg; meningococcal polysaccharide antigen group c 50mcg; sodium chloride .5ml - vaccines

Kanada - engelska - Health Canada

glaxosmithkline inc - meningococcal polysaccharide antigen group a; meningococcal polysaccharide antigen group c; sodium chloride - powder for solution - 500mcg; 500mcg; 5ml - meningococcal polysaccharide antigen group a 500mcg; meningococcal polysaccharide antigen group c 500mcg; sodium chloride 5ml - vaccines

Australien - engelska - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - meningococcal oligosaccharide group a, quantity: 10 microgram; meningococcal oligosaccharide group c, quantity: 5 microgram; meningococcal polysaccharide group w135, quantity: 5 microgram; meningococcal polysaccharide group y, quantity: 5 microgram - injection, solution - excipient ingredients: sodium chloride; monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate; water for injections - menveo is indicated for active immunisation of children (from 2 years of age), adolescents and adults to prevent invasive disease caused by neisseria meningitidis serogroups a, c, w135 and y. the use of this vaccine should be in accordance with official recommendations.

Malta - engelska - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - neisseria meningitidis, polysaccharide group, tetanus toxoid - suspension for injection - neisseria meningitidis polysaccharide group c tetanus toxoid - vaccines

USA - engelska - NLM (National Library of Medicine)

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen (unii: re9a0h8oab) (neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen - unii:re9a0h8oab), neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen (unii: 2j57k2523t) (neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen - unii:2j57k2523t), neisseria meningitidis group y capsular polysaccharide diphtheria - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen 4 ug in 0.5 ml - menactra® , meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, y and w-135. menactra is approved for use in individuals 9 months through 55 years of age. menactra does not prevent n meningitidis serogroup b disease. severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or crm197 -containing vaccine, or to any component of menactra [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menactra during pregnancy. to enroll in or obtain information about the registry, call sanofi pasteur at 1-800-822-2463. 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 an

Israel - engelska - Ministry of Health

pfizer pharmaceuticals israel ltd - neisseria meningitidis group a polysaccharide; neisseria meningitidis group c polysaccharide; neisseria meningitidis group w - 135 polysaccharide; neisseria meningitidis group y polysaccharide - powder and solvent for solution for injection - neisseria meningitidis group y polysaccharide 5 mcg; neisseria meningitidis group w - 135 polysaccharide 5 mcg; neisseria meningitidis group c polysaccharide 5 mcg; neisseria meningitidis group a polysaccharide 5 mcg - other meningococcal monovalent purified polysaccharides antigen - other meningococcal monovalent purified polysaccharides antigen - nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by neisseria meningitidis group a, c, w-135 and y.

Nya Zeeland - engelska - 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