Unjoni Ewropea - Ingliż - 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.

Malasja - Ingliż - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - neisseria meningitides,group a polysaccharide; neisseria meningitides,group c polysaccharide; neisseria meningitides,group y polysaccharide; neisseria meningitides,group w-135 polysaccaride; tetanus toxoid carrier protein -

Stati Uniti - Ingliż - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - neisseria meningitidis group b nhba fusion protein antigen (unii: 28e911y7ae) (neisseria meningitidis group b nhba fusion protein antigen - unii:28e911y7ae), neisseria meningitidis group b fhbp fusion protein antigen (unii: 25db599g64) (neisseria meningitidis group b fhbp fusion protein antigen - unii:25db599g64), neisseria meningitidis group b nada protein antigen (unii: 1s25r442rs) (neisseria meningitidis group b nada protein antigen - unii:1s25r442rs), neisseria meningitidis group b strain nz98/254 outer membrane vesicle antigen (unii: 91523m4s24) (neisseria meningitidis group b strain nz98/254 outer membrane vesicle antigen - unii:91523m4s24) - neisseria meningitidis serogroup b nhba fusion protein antigen 50 ug in 0.5 ml - bexsero is a vaccine indicated for active immunization to prevent invasive disease caused by neisseria meningitidis serogroup b. bexsero is approved for use in individuals aged 10 through 25 years. approval of bexsero is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup b strains representative of prevalent strains in the united states. the effectiveness of bexsero against diverse serogroup b strains has not been confirmed. hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of bexsero [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 bexsero in pregnant women in the u.s. available human data on bexsero administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study was performed in female rabbits administered bexsero prior to mating and during gestation. the dose was 0.5 ml at each occasion (a single human dose is 0.5 ml). this study revealed no adverse effects on fetal or pre-weaning development due to bexsero (see data) . data animal data: in a developmental toxicity study, female rabbits were administered bexsero 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 fetal malformations or variations observed. risk summary it is not known whether the vaccine components of bexsero are excreted in human milk. available data are not sufficient to assess the effects of bexsero on 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 bexsero and any potential adverse effects on the breastfed child from bexsero 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 bexsero have not been established in children younger than 10 years. safety and effectiveness of bexsero have not been established in adults older than 65 years.

Stati Uniti - Ingliż - 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

Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

gsk vaccines s.r.l. - meningococcal group c oligosaccharide; corynebacterium diphtheriae crm197 protein - suspension for injection - 10 - meningococcal vaccines; other meningococcal polyvalent purified polysaccharides antigen

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - meningococcal polysaccharide group c, quantity: 5 microgram; meningococcal polysaccharide group y, quantity: 5 microgram; meningococcal polysaccharide group w135, quantity: 5 microgram; meningococcal polysaccharide group a, quantity: 5 microgram; tetanus toxoid, quantity: 44 microgram - injection, powder for - excipient ingredients: sucrose; trometamol hydrochloride - nimenrix is indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal diseases caused by neisseria meningitidis groups a, c, w-135 and y.

Stati Uniti - Ingliż - NLM (National Library of Medicine)

wyeth pharmaceutical division of wyeth holdings llc - neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen (unii: 583wcd0izi) (neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen - unii:583wcd0izi), neisseria meningitidis group b recombinant lp2086 b01 protein variant antigen (unii: 7mbd4k530d) (neisseria meningitidis group b recombinant lp2086 b01 protein variant antigen - unii:7mbd4k530d) - neisseria meningitidis group b recombinant lp2086 a05 protein variant antigen 60 ug in 0.5 ml - trumenba is indicated for active immunization to prevent invasive disease caused by neisseria meningitidis serogroup b. trumenba is approved for use in individuals 10 through 25 years of age. severe allergic reaction (e.g. anaphylaxis) to any component of trumenba [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 trumenba in pregnant women. available human data on trumenba administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. two developmental toxicity studies were performed in female rabbits administered trumenba prior to mating and during gestation. the dose was 0.5 ml at each occasion (a single human dose is 0.5 ml). these studies revealed no evidence of harm to the fet

Stati Uniti - Ingliż - 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.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - diphtheria crm197 protein, quantity: 16.7 microgram; meningococcal oligosaccharide group a, quantity: 10 microgram - injection, powder for - excipient ingredients: sucrose; monobasic potassium phosphate - menveo is indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by neisseria meningitidis serogroups a, c, w-135 and y. the use of this vaccine should be in accordance with official recommendations.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - meningococcal oligosaccharide group y, quantity: 5 microgram; meningococcal oligosaccharide group c, quantity: 5 microgram; diphtheria crm197 protein, quantity: 16 microgram; meningococcal oligosaccharide group w135, quantity: 5 microgram - injection, solution - excipient ingredients: sodium chloride; water for injections; monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate - menveo is indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by neisseria meningitidis serogroups a, c, w-135 and y. the use of this vaccine should be in accordance with official recommendations.