Vereinigte Staaten - Englisch - 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.

Vereinigte Staaten - Englisch - 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) ].

Vereinigte Staaten - Englisch - 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

Israel - Englisch - Ministry of Health

alexion pharma israel ltd - ravulizumab - concentrate for solution for infusion - ravulizumab 100 mg/ml - ravulizumab - ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria (pnh): * in patients with haemolysis with clinical symptom(s) indicative of high disease activity. * in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome ahus who are complement inhibitor treatment naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab. ultomiris is indicated in the treatment of adult patients with generalized myasthenia gravis (gmg) who are antiacetylcholine receptor (achr) antibody-positive.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

alexion pharmaceuticals inc. - danicopan (unii: jm8c1sfx0u) (danicopan - unii:jm8c1sfx0u) - voydeya is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (evh) in adults with paroxysmal nocturnal hemoglobinuria (pnh). limitations of use voydeya has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab. voydeya is contraindicated for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including neisseria meningitidis , streptococcus pneumoniae , or haemophilus influenzae type b [see warnings and precautions (5.1)] . risk summary there are no available data on voydeya use in pregnant individuals to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with untreated pnh in pregnancy (see clinical considerations) . the use of voydeya in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits. in animal reproduction studies, oral administration of danicopan to pregnant new zealand white (nzw) rabbits and wistar hans (wh) rats during organogenesis at exposures 18 or 25-times, respectively, above the human exposure at the maximum recommended human dose (mrhd) of 200 mg three times a day (based on auc) resulted in no adverse developmental effects (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background 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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or fetal/neonatal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages, and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. data animal data there were no effects on early embryonic development and fetal development in nzw rabbits (where danicopan is pharmacodynamically active) up to a mean maternal systemic exposure 18-times the exposure at the mrhd (based on auc) or during post-natal development up to a mean maternal systemic exposure 9-times the exposure at the mrhd (based on auc). in wh rats (where danicopan lacks pharmacodynamic activity), there were no effects on embryo-fetal development up to a mean maternal exposure 25-times the exposure at the mrhd (based on auc). risk summary there are no data on the presence of danicopan in human milk, the effects on the breastfed child, or the effect on milk production. danicopan is present in animal milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. because of the potential for serious adverse reactions in the breastfed child, including serious infections with encapsulated bacteria and liver enzyme increases, advise patients not to breastfeed during treatment with voydeya, and for 3-days after the last dose. data animal data danicopan was excreted into the milk of lactating rabbits following oral administration from lactation day 4 to lactation day 10, with mean milk concentrations at approximately 2 hours following dose administration 5- and 3.5-times higher than the mean maternal plasma concentrations at 50 and 250 mg/kg/day, respectively. mean milk concentrations in dams were 19- and 43-times higher than the systemic exposure at the mrhd (based on rabbit concentration at 2 hours vs. human cmax ). safety and effectiveness of voydeya for the treatment of pnh in pediatric patients have not been established. there were 22 patients 65 years of age and older in the clinical studies for pnh [see clinical studies (14)] . of the total number of voydeya-treated patients in these studies, 16 (28.1%) were 65 years of age and older, and 7 (12.3%) were 75 years of age and older. clinical studies of voydeya did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. no dose adjustment is required in patients with mild to moderate hepatic impairment (child-pugh class a and b). studies have not been conducted in patients with severe hepatic impairment, therefore, avoid use of voydeya in this patient population [see warnings and precautions (5.3)] .

Israel - Englisch - Ministry of Health

sanofi israel ltd - meningococcal vaccines group a; meningococcal vaccines group c; meningococcal vaccines group w; meningococcal vaccines group y - solution for injection - meningococcal vaccines group c 4 mcg / 0.5 ml; meningococcal vaccines group y 4 mcg / 0.5 ml; meningococcal vaccines group w 4 mcg / 0.5 ml; meningococcal vaccines group a 4 mcg / 0.5 ml - other meningococcal monovalent purified polysaccharides antigen - other meningococcal monovalent purified polysaccharides antigen - active immunization of individuals 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 does not prevent n meningitidis serogroup b disease.

Irland - Englisch - 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

Europäische Union - Englisch - EMA (European Medicines Agency)

gsk vaccines s.r.l. - outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant neisseria meningitidis group b fhbp fusion protein, recombinant neisseria meningitidis group b nada protein, recombinant neisseria meningitidis group b nhba fusion protein - meningitis, meningococcal - meningococcal vaccines - active immunisation against invasive disease caused by neisseria meningitidis serogroup-b strains.,

Europäische Union - Englisch - EMA (European Medicines Agency)

pfizer europe ma eeig - neisseria meningitidis serogroup b fhbp (recombinant lipidated fhbp (factor h binding protein)) subfamily a; neisseria meningitidis serogroup b fhbp (recombinant lipidated fhbp (factor h binding protein)) subfamily b - meningitis, meningococcal - bacterial vaccines, meningococcal vaccines - trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by neisseria meningitidis serogroup b.the use of this vaccine should be in accordance with official recommendations.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - haemophilus influenza type b polyribose ribitol phosphate,meningococcal polysaccharide group c,tetanus toxoid -