Malta - English - Medicines Authority

smithkline beecham limited 980, great west road, brentford middlesex tw8 9gs, united kingdom - neisseria meningitidis, polysaccharide group, meningococcal polysaccharide, group w - powder and solvent for solution for injection - neisseria meningitidis polysaccharide group c 50 µg meningococcal polysaccharide group w-135 50 µg - vaccines

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - neisseria meningitidis group y capsular polysaccharide protein conjugate; neisseria meningitidis group w135 capsular polysaccharide protein conjugate; neisseria meningitidis group a capsular polysaccharide protein conjugate; neisseria meningitidis group c capsular polysaccharide protein conjugate - powder and solvent for solution for injection

European Union - English - EMA (European Medicines Agency)

sanofi pasteur - neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid - meningitis, meningococcal - vaccines - menquadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y.the use of this vaccine should be in accordance with available official recommendations.

Malta - English - 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

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen (unii: t4gyx3110d) (neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen - unii:t4gyx3110d), neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen (unii: zt89e5a103) (neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen - unii:zt89e5a103), neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen (unii: 4wan8pqk15) (neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen - unii:4wan8pqk15), neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen (unii: l77ok410kw) (neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen - unii:l77ok410kw) - menquadfi® is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. menquadfi is indicated for use in individuals 2 years of age and older. menquadfi does not prevent n. meningitidis serogroup b disease. severe allergic reaction to any component of the vaccine, or after a previous dose of menquadfi or any other tetanus toxoid-containing vaccine [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menquadfi 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 and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there are no clinical studies of menquadfi in pregnant women. available human data on menquadfi administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study in female rabbits administered a full human dose (0.5 ml) prior to mating and during gestation period revealed no evidence of harm to the fetus due to menquadfi (see animal data ). data animal data in a developmental toxicity study, female rabbits received a human dose of menquadfi by intramuscular injection on five occasions: 30 days and 10 days prior to mating, gestation days 6, 12 and 27. no adverse effects on pre-weaning development up to post-natal day 35 were observed. there were no vaccine-related fetal malformations or variations observed. risk summary it is not known whether menquadfi is excreted in human milk. data are not available to assess the effects of menquadfi 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 menquadfi and any potential adverse effects on the breastfed child from menquadfi 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 menquadfi have not been established in individuals younger than 2 years of age in the us. a total of 249 participants 65 years of age and older, including 71 participants 75 years of age or older, in study 4 received one dose of menquadfi [see adverse reactions (6.1) and clinical studies (14.1) ]. menquadfi recipients ≥ 65 years of age had lower gmts and seroresponse rates for all serogroups compared to menquadfi recipients 56 through 64 years of age [see clinical studies (14.1) ].

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - neisseria meningitidis group a polysaccharide 10ug (conjugated to tetanus toxoid); neisseria meningitidis group c polysaccharide 10ug (conjugated to tetanus toxoid); neisseria meningitidis group w135 polysaccharide 10ug (conjugated to tetanus toxoid); neisseria meningitidis group y polysaccharide 10ug (conjugated to tetanus toxoid) - solution for injection - 0.5 ml - active: neisseria meningitidis group a polysaccharide 10ug (conjugated to tetanus toxoid) neisseria meningitidis group c polysaccharide 10ug (conjugated to tetanus toxoid) neisseria meningitidis group w135 polysaccharide 10ug (conjugated to tetanus toxoid) neisseria meningitidis group y polysaccharide 10ug (conjugated to tetanus toxoid) excipient: sodium acetate sodium chloride tetanus toxoid water for injection - menquadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w and y. the use of menquadfi should be in accordance with official recommendations.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - neisseria meningitidis group a polysaccharide 100 µg/ml; neisseria meningitidis group c polysaccharide 100 µg/ml - powder for injection - 50µg,50µg/0.5ml - active: neisseria meningitidis group a polysaccharide 100 µg/ml neisseria meningitidis group c polysaccharide 100 µg/ml excipient: lactose monohydrate

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - neisseria meningitidis group a polysaccharide 100 µg/ml (polysaccharide) - injection with diluent - 50µg/0.5ml - active: neisseria meningitidis group a polysaccharide 100 µg/ml (polysaccharide) excipient: thiomersal water for injection

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - neisseria meningitidis group c capsular polysaccharide protein conjugate - suspension for injection

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

a-s medication solutions - neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen (unii: t4gyx3110d) (neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen - unii:t4gyx3110d), neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen (unii: zt89e5a103) (neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen - unii:zt89e5a103), neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugat - menquadfi® is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. menquadfi is indicated for use in individuals 2 years of age and older. menquadfi does not prevent n. meningitidis serogroup b disease. severe allergic reaction to any component of the vaccine, or after a previous dose of menquadfi or any other tetanus toxoid-containing vaccine [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menquadfi 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 and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there are no clinical studies of menquadfi