New Zealand - English - 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

United States - English - 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.

United States - English - 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

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

novartis vaccines and diagnostics srl - neisseria meningitidis serogroup b nhba fusion protein antigen (unii: 28e911y7ae) (neisseria meningitidis serogroup b nhba fusion protein antigen - unii:28e911y7ae) - neisseria meningitidis serogroup b nhba fusion protein antigen 50 ug in 0.5 ml

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide antigen (unii: 1i86b47ny4) (neisseria meningitidis group a capsular polysaccharide antigen - unii:1i86b47ny4) - neisseria meningitidis group a capsular polysaccharide antigen 50 ug in 0.5 ml

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide antigen (unii: 1i86b47ny4) (neisseria meningitidis group a capsular polysaccharide antigen - unii:1i86b47ny4) - neisseria meningitidis group a capsular polysaccharide antigen 50 ug in 0.5 ml

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - neisseria meningitides group b strain nz98/254; neisseria meningitidis group b fhbp fusion protein; neisseria meningitidis group b nada protein; neisseria meningitidis group b nhba fusion protein - suspension for injection - neisseria meningitides group b strain nz98/254 25 mcg; neisseria meningitidis group b fhbp fusion protein 50 mcg; neisseria meningitidis group b nada protein 50 mcg; neisseria meningitidis group b nhba fusion protein 50 mcg - meningococcus b, outer membrane vesicle vaccine - bexsero is indicated for active immunization of individuals from 2 months of age and older against invasive meningococcal disease caused by neisseria meningitidis group b.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - neisseria meningitidis group c polysaccharide 10ug (polysaccharide antigen from strain c11, conjugated to tetanus toxoid) - suspension for injection - 10 mcg/0.5ml - active: neisseria meningitidis group c polysaccharide 10ug (polysaccharide antigen from strain c11, conjugated to tetanus toxoid) excipient: aluminium hydroxide sodium chloride tetanus toxoid water for injection - active immunisation of children from 8 weeks of age, adolescents and adults for the prevention of invasive disease caused by neisseria meningitidis serogroup c.

Israel - English - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - neisseria meningitidis serogroup b recombinant lipidated- factor h binding protein subfamily a, quantity: 60 microgram; neisseria meningitidis serogroup b recombinant lipidated- factor h binding protein subfamily b, quantity: 60 microgram - injection, suspension - excipient ingredients: water for injections; aluminium phosphate; histidine; sodium chloride; polysorbate 80 - trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by neisseria meningitidis serogroup b.