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

glaxosmithkline biologicals sa - human rotavirus a type g1p(8) strain rix4414 live antigen (unii: kz3l01d2pc) (human rotavirus a type g1p(8) strain rix4414 live antigen - unii:kz3l01d2pc) - human rotavirus a type g1p(8) strain rix4414 live antigen 1000000 [ccid_50] in 1 ml - rotarix is indicated for the prevention of rotavirus gastroenteritis caused by g1 and non-g1 types (g3, g4, and g9) when administered as a 2-dose series [see clinical studies (14.3)] . rotarix is approved for use in infants 6 weeks and up to 24 weeks of age. a demonstrated history of hypersensitivity to any component of the vaccine. infants who develop symptoms suggestive of hypersensitivity after receiving a dose of rotarix should not receive further doses of rotarix. infants with a history of uncorrected congenital malformation of the gastrointestinal tract (such as meckel’s diverticulum) that would predispose the infant for intussusception should not receive rotarix. infants with a history of intussusception should not receive rotarix [see warnings and precautions (5.5)] . in postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose [see adverse reactions (6.2)] . infants with severe combined immunodeficiency disease (scid) should not receive rotarix. postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered live, oral rotavirus vaccines and later identified as having scid [see adverse reactions (6.2)] . safety and effectiveness of rotarix in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated. the effectiveness of rotarix in pre-term infants has not been established. safety data are available in pre-term infants (rotarix = 134, placebo = 120) with a reported gestational age ≤36 weeks. these pre-term infants were followed for saes up to 30 to 90 days after dose 2. saes were observed in 5.2% of recipients of rotarix as compared with 5.0% of placebo recipients. no deaths or cases of intussusception were reported in this population.

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

glaxosmithkline biologicals sa - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq), hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 720 [iu] in 1 ml - twinrix is indicated for active immunization against disease caused by hepatitis a virus and infection by all known subtypes of hepatitis b virus. twinrix is approved for use in persons 18 years of age or older. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing or hepatitis b-containing vaccine, or to any component of twinrix, including yeast and neomycin, is a contraindication to administration of twinrix [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 twinrix in pregnant women in the u.s. available data do not suggest an increased risk of major birth defects and miscarriage in women who received twinrix within 28 days prior to conception or during pregnancy (see data) . a developmental toxicity study was performed in female rats administered twinrix prior to mating and during gestation (0.2 ml at each occasion). this study revealed no adverse effects on fetal or pre-weaning development (see data) . data human data: a pregnancy exposure registry was maintained from 2001 to 2015. the registry prospectively enrolled 245 women who received a dose of twinrix during pregnancy or within 28 days prior to conception. after excluding induced abortions (n = 6, including one of a fetus with congenital anomalies), those lost to follow-up (n = 142), those with exposure in the third trimester (n = 1), and those with an unknown exposure timing (n = 9), there were 87 pregnancies with known outcomes with exposure within 28 days prior to conception, or in the first or second trimesters. miscarriage was reported for 9.6% of pregnancies with exposure to twinrix prior to 20 weeks gestation (8/83). major birth defects were reported for 3.8% of live born infants whose mothers were exposed within 28 days prior to conception or during the first or second trimester (3/80). the rates of miscarriage and major birth defects were consistent with estimated background rates. in pre- and post-licensure clinical studies of twinrix, 45 pregnant women were inadvertently administered twinrix following their last menstrual period. among such pregnancies, after excluding elective terminations (n = 1) and those lost to follow-up (n = 1), there were 43 pregnancies with known outcomes all with exposure in the first trimester. miscarriage was reported in 16% of pregnancies (7/43) and major birth defects were reported in 2.6% of live births (1/38). the rates of miscarriage and major birth defects were consistent with estimated background rates. animal data: in a developmental toxicity study, female rats were administered twinrix by intramuscular injection on day 30 prior to mating and on gestation days 6, 8, 11, and 15. the total dose was 0.2 ml (divided) at each occasion (a single human dose is 1 ml). no adverse effects on pre-weaning development up to post-natal day 25 were observed. there were no fetal malformations or variations. risk summary there is no information regarding the presence of twinrix in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for twinrix and any potential adverse effects on the breastfed child from twinrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness in pediatric patients younger than 18 years have not been established. clinical studies of twinrix did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects [see clinical studies (14.1, 14.3)] .

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)

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.

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

glaxosmithkline biologicals sa - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) (unii: 5bfc8lz6lq) (hepatitis a virus strain hm175 antigen (formaldehyde inactivated) - unii:5bfc8lz6lq) - hepatitis a virus strain hm175 antigen (formaldehyde inactivated) 720 [iu] in 0.5 ml - havrix is indicated for active immunization against disease caused by hepatitis a virus (hav). havrix is approved for use in persons 12 months of age and older. primary immunization should be administered at least 2 weeks prior to expected exposure to hav. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis a-containing vaccine, or to any component of havrix, including neomycin, is a contraindication to administration of havrix [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 havrix in pregnant women in the u.s. available data do not suggest an increased risk of major birth defects and miscarriage in women who received havrix during pregnancy (see data) . there are no animal studies with havrix to inform use during pregnancy. data human data: in pre- and post-licensure clinical studies of havrix, 175 pregnant women (177 outcomes, including two sets of twins) were inadvertently administered havrix following their last menstrual period. after excluding ectopic pregnancies (n = 2), molar pregnancies (n = 1), elective terminations (n = 22, including one of a fetus with a birth defect), those that were lost to follow-up (n = 9), and those with an unknown exposure timing (n = 5), there were 138 known pregnancy outcomes with exposure during the first or second trimester. of these, miscarriage was reported in 11% of pregnancies exposed prior to 20 weeks gestation (15/136) and major birth defects were reported in 3.3% (4/123) of live births. the rates of miscarriage and major birth defects were consistent with estimated background rates. risk summary there is no information regarding the presence of havrix in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for havrix and any potential adverse effects on the breastfed child from havrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. the safety and effectiveness of havrix, doses of 360 el.u. or 720 el.u., have been evaluated in more than 22,000 subjects aged 1 to 18 years. the safety and effectiveness of havrix have not been established in subjects younger than 12 months. clinical studies of havrix did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects. subjects with chronic liver disease had a lower antibody response to havrix than healthy subjects [see clinical studies (14.3)] .

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

glaxosmithkline biologicals sa - measles virus strain schwartz attenuated chick embryo fibroblasts live antigen (unii: yrf2uzg52m) (measles virus strain schwartz attenuated chick embryo fibroblasts live antigen - unii:yrf2uzg52m), mumps virus strain rit-4385 attenuated chick embryo fibroblasts live antigen (unii: 566fj5l8r4) (mumps virus strain rit-4385 attenuated chick embryo fibroblasts live antigen - unii:566fj5l8r4), rubella virus strain wistar ra 27/3 live antigen (unii: 52202h034z) (rubella virus strain wistar ra 27/3 live antigen - priorix is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. do not administer priorix to individuals with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine [see description (11)] . due to the risk of disseminated vaccine virus infection, do not administer priorix to individuals with severe humoral or cellular (primary or acquired) immunodeficiency. do not administer priorix to individuals who are pregnant. pregnancy should be avoided for 1 month after vaccination [see use in specific populations (8.1)] . risk summary priorix contains live attenuated measles, mumps, and rubella viruses. the vaccine is contraindicated for use in pregnant women because infection during pregnancy with the wild-type viruses is associated with maternal and fetal adverse outcomes. pregnancy should be avoided for 1 month af

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

glaxosmithkline biologicals sa - recombinant respiratory syncytial virus pre-fusion f protein (unii: m739eb7427) (recombinant respiratory syncytial virus pre-fusion f protein - unii:m739eb7427) - arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in individuals 60 years of age and older. do not administer arexvy to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of arexvy [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. arexvy is not approved for use in persons <60 years of age. in a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted rsv vaccine that contained the same rsvpref3 antigen as arexvy, an increase in preterm births was observed compared to pregnant individuals who received placebo (sucrose reconstituted with saline). data in a randomized controlled clinical trial that enroll

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis a vaccine 720 eu/ml;  ; hepatitis b surface antigen, recombinant 20 µg/ml; hepatitis a vaccine 720 eu/ml; hepatitis b surface antigen, recombinant 20 µg/ml - suspension for injection - active: hepatitis a vaccine 720 eu/ml   hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium amino acids formaldehyde neomycin sulfate phenoxyethanol polysorbate 20 sodium chloride water for injection active: hepatitis a vaccine 720 eu/ml hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium amino acids dibasic sodium phosphate monohydrate formaldehyde monobasic sodium phosphate dihydrate neomycin sulfate polysorbate 20 sodium chloride trometamol water for injection - twinrix is indicated for active immunisation against hepatitis a and hepatitis b virus infection in adults. twinrix is also indicated for active immunisation against hepatitis a and hepatitis b virus infection in infants, children and adolescents from 1 year up to and including 15 years of age at risk of, or who wish to be protected against, both infections.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - hepatitis a vaccine 720 eu/ml;  ; hepatitis b surface antigen, recombinant 20 µg/ml; hepatitis a vaccine 720 eu/ml; hepatitis b surface antigen, recombinant 20 µg/ml - suspension for injection - active: hepatitis a vaccine 720 eu/ml   hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium amino acids formaldehyde neomycin sulfate phenoxyethanol polysorbate 20 sodium chloride water for injection active: hepatitis a vaccine 720 eu/ml hepatitis b surface antigen, recombinant 20 µg/ml excipient: aluminium amino acids dibasic sodium phosphate monohydrate formaldehyde monobasic sodium phosphate dihydrate neomycin sulfate polysorbate 20 sodium chloride trometamol water for injection - twinrix junior is indicated for active immunisation against hepatitis a and hepatitis b virus infection in infants, children and adolescents from 1 year up to and including 15 years of age at risk of, or who wish to be protected against, both infections.

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid - injection - 30 iu/0.5 ml