Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - haemophilus influenzae type b, conjugate with tetanus protein - pdr+solv for soln for inj - 10mcg/0.5m microgram/ml - hemophilus influenzae b vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - polio virus type 1 inactivated, polio virus type 2 inactivated, polio virus type 3 inactivated - suspension for injection - %v/v - poliomyelitis 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) ].

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - strain cr 326f hepatitis a virus, inactivated 50 u - solution for injection - 50iu/1ml units/ml - hepatitis vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - hepatitis a vaccine - solution for injection - 25iu/0.5 m units/ml - hepatitis vaccines

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - tetanus toxoid - suspension for injection in pre-filled syringe - tetanus toxoid - vaccines

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

sanofi pasteur, kenya - attenuated yellow fever - freeze dried powder for injection single dose - 17 d/ab 237 > 1000 ld50/05 ml

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

sanofi-aventis australia pty ltd - sevelamer hydrochloride -

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

sanofi-aventis australia pty ltd - sevelamer hydrochloride -

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

sanofi-aventis australia pty ltd - sevelamer carbonate -