ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - neisseria meningitidis group b neisseria heparin binding antigen fusion protein, quantity: 50 microgram; neisseria meningitidis serogroup b outer membrane vesicles, quantity: 25 microgram; neisseria meningitidis group b factor h binding protein fusion protein, quantity: 50 microgram; neisseria meningitidis group b neisseria adhesin a protein, quantity: 50 microgram - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; histidine; sodium chloride; sucrose - bexsero is indicated for active immunisation against invasive disease caused by n. meningitidis group b strains. for information on protection against specific group b strains see section 5.1 pharmacodynamic properties. bexsero is indicated for vaccination of individuals from 2 months of age and older.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - neisseria meningitidis group b factor h binding protein fusion protein, quantity: 50 microgram; neisseria meningitidis group b neisseria adhesin a protein, quantity: 50 microgram; neisseria meningitidis serogroup b outer membrane vesicles, quantity: 25 microgram; neisseria meningitidis group b neisseria heparin binding antigen fusion protein, quantity: 50 microgram - injection, suspension - excipient ingredients: sucrose; histidine; water for injections; aluminium hydroxide hydrate; sodium chloride - bexsero is indicated for active immunisation against invasive disease caused by n. meningitidis group b strains. for information on protection against specific group b strains see section 5.1 pharmacodynamic properties. bexsero is indicated for vaccination of individuals from 2 months of age and older.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

in vitro technologies pty ltd - ct793 - neisseria ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to neisseria bacteria in nucleic acid extracted from whole blood, cerebrospinal fluid, and nasopharyngeal swab specimens.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

speedx pty ltd - ct793 - neisseria ivds - ivds that are intended to be used in testing to provide information about infection or exposure to neisseria bacteria

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - diphtheria toxoid protein; meningococcal (serogroup a) polysaccharide (monovalent conjugate); meningococcal (serogroup c) polysaccharide (monovalent conjugate); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate); meningococcal (serogroup y) polysaccharide (monovalent conjugate) - injection, solution - 48 microgram (diptheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio) - diphtheria toxoid protein 48 mcg/dose (0.5 ml) (diphtheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio); meningococcal (serogroup a) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup c) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup y) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml)

संयुक्त राज्य - अंग्रेज़ी - 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) ].

संयुक्त राज्य - अंग्रेज़ी - 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

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - meningococcal polysaccharide 48ug (4 µg of each of groups a, c, y & w-135, each separately conjugated to diphtheria toxoid, 48 µg total) - solution for injection - 4 µg each/0.5 ml - active: meningococcal polysaccharide 48ug (4 µg of each of groups a, c, y & w-135, each separately conjugated to diphtheria toxoid, 48 µg total) excipient: dibasic sodium phosphate monobasic sodium phosphate sodium chloride water for injection - menactra vaccine is indicated for active immunisation in individuals from 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by n. meningitidis serogroups a, c, y and w-135. menactra vaccine is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by n meningitidis serogroup b. menactra vaccine is not indicated for treatment of meningococcal infections. menactra vaccine is not indicated for immunisation against diphtheria.

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - meningococcal oligosaccharide - group c 10ug (conjugated with 5 mcg diphtheria crm 197 protein);   - suspension for injection - 0.5 ml - active: meningococcal oligosaccharide - group c 10ug (conjugated with 5 mcg diphtheria crm 197 protein)   excipient: aluminium phosphate sodium chloride water for injection - active immunisation of children from 6 weeks of age, adolescents and adults for the prevention of invasive disease caused by neisseria meningitidis serogroup c.

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - (mena lyo) meningococcal group a oligosaccharide conjugated to crm197 protein; (mencwy) meningococcal group c oligosaccharide conjugated to crm197 protein; (mencwy) meningococcal group w-135 oligosaccharide conjugated to crm197 protein; (mencwy) meningococcal group y oligosaccharide conjugated to crm197 protein - injection, powder, for solution - 10 microgram conjugated to 16.7-33.3 microgram - (mena lyo) meningococcal group a oligosaccharide conjugated to crm197 protein 10 microgram conjugated to 16.7-33.3 microgram; (mencwy) meningococcal group c oligosaccharide conjugated to crm197 protein 5 microgram conjudated to 7.1-12.5 microgram; (mencwy) meningococcal group w-135 oligosaccharide conjugated to crm197 protein 5 microgram conjugated to 3.3-8.3 microgram; (mencwy) meningococcal group y oligosaccharide conjugated to crm197 protein 5 microgram conjugated to 5.6-10 microgram