Canada - English - Health Canada

sanofi pasteur limited - meningococcal polysaccharide antigen group a; meningococcal polysaccharide antigen group c; meningococcal polysaccharide antigen group y; meningococcal polysaccharide antigen group w-135 - kit - 50mcg; 50mcg; 50mcg; 50mcg - meningococcal polysaccharide antigen group a 50mcg; meningococcal polysaccharide antigen group c 50mcg; meningococcal polysaccharide antigen group y 50mcg; meningococcal polysaccharide antigen group w-135 50mcg - vaccines

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

meningococcal (serogroup a) polysaccharide (monovalent conjugate), meningococcal (serogroup c) polysaccharide (monovalent conjugate), diphtheria toxoid protein (carrier protein for all serogroup polysaccharide conjugate), meningococcal (serogroup w-135) polysaccharide (monovalent conjugate), meningococcal (serogroup y) polysaccharide (monovalent conjugate) -

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - neisseria meningitidis group a polysaccharide 50ug; neisseria meningitidis group c polysaccharide 50ug; neisseria meningitidis group w135 polysaccharide 50ug; neisseria meningitidis group y polysaccharide 50ug - injection with diluent - 0.5 ml - active: neisseria meningitidis group a polysaccharide 50ug neisseria meningitidis group c polysaccharide 50ug neisseria meningitidis group w135 polysaccharide 50ug neisseria meningitidis group y polysaccharide 50ug excipient: lactose monohydrate sodium chloride purified water - menomune® acyw-135 is indicated for active immunisation of adults and children older than 2 years against disease caused by neisseria meningitidis groups a, c, y and w-135, the major manifestation being meningococcal meningitis. vaccination may be considered for the following individuals: · travellers to countries recognised as having highly endemic or epidemic disease. · control of epidemics of infection caused by neisseria meningitidis groups a, c, y and w-135 in confined communities. · individuals at particular high risk of acquiring meningococcal infection, including persons with anatomic or functional asplenia. · close contacts of persons with meningococcal disease due to groups a, c, y and w-135, as an adjunct to appropriate chemoprophylaxis.

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

pfizer australia pty ltd - diphtheria crm197 protein; meningococcal polysaccharide - group c -

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

sanofi pasteur inc. - salmonella typhi ty2 vi polysaccharide antigen (unii: 7194h8w3kt) (salmonella typhi ty2 vi polysaccharide antigen - unii:7194h8w3kt) - salmonella typhi ty2 vi polysaccharide antigen 25 ug in 0.5 ml - typhim vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by s typhi and is approved for use in persons two years of age or older. immunization with typhim vi vaccine should occur at least two weeks prior to expected exposure to s typhi . typhim vi vaccine is not indicated for routine immunization of individuals in the united states (us). (14) selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with s typhi . (14) typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as africa, asia, and central and south america where there is a recognized r

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

a-s medication solutions - salmonella typhi ty2 vi polysaccharide antigen (unii: 7194h8w3kt) (salmonella typhi ty2 vi polysaccharide antigen - unii:7194h8w3kt) - salmonella typhi ty2 vi polysaccharide antigen 25 ug in 0.5 ml - typhim vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by s typhi and is approved for use in persons two years of age or older. immunization with typhim vi vaccine should occur at least two weeks prior to expected exposure to s typhi . typhim vi vaccine is not indicated for routine immunization of individuals in the united states (us). (14) selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with s typhi . (14) typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as africa, asia, and central and south america where there is a recognized r

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

a-s medication solutions - salmonella typhi ty2 vi polysaccharide antigen (unii: 7194h8w3kt) (salmonella typhi ty2 vi polysaccharide antigen - unii:7194h8w3kt) - salmonella typhi ty2 vi polysaccharide antigen 25 ug in 0.5 ml - typhim vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by s typhi and is approved for use in persons two years of age or older. immunization with typhim vi vaccine should occur at least two weeks prior to expected exposure to s typhi . typhim vi vaccine is not indicated for routine immunization of individuals in the united states (us). (14) selective immunization against typhoid fever is recommended under the following circumstances: 1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with s typhi . (14) typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as africa, asia, and central and south america where there is a recognized r

Australia - English - 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.

United States - English - 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - conjugate of haemophilus influenzae type b capsular polysaccharide (polyribosylribitol phosphate) and tetanus; conjugate of neisseria meningitides c capsular polysaccharide and tetanus toxoid (mean tt/ps ratio :1) - powder and solvent for solution for injection - 0.5 millilitre(s) - hemophilus influenzae b, combinations with meningococcus c, conjugated