Irlanda - Ingliż - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - polio virus type 1 inactivated, polio virus type 2 inactivated, polio virus type 3 inactivated - suspension for injection - %v/v - poliomyelitis vaccines

Irlanda - Ingliż - 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

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

sanofi pasteur msd, snc - polyribosylribitol phosphate from haemophilus influenzae type b as prp-ompc, outer membrane protein complex of neisseria meningitidis (outer membrane protein complex of the b11 strain of neisseria meningitidis subgroup b), adsorbed hepatitis b surface antigen produced in recombinant yeast cells (saccharomyces cerevisiae) - hepatitis b; meningitis, haemophilus; immunization - vaccines - procomvax is indicated for vaccination against invasive disease caused by haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis b virus in infants 6 weeks to 15 months of age.,

Kanada - Ingliż - Health Canada

aventis pasteur limited - diphtheria toxoid - liquid - 0.2lf - diphtheria toxoid 0.2lf - diphtheria

Stati Uniti - Ingliż - NLM (National Library of Medicine)

sanofi pasteur inc. - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h) - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml - tenivac® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of tenivac or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of tenivac. [see description (11) .] because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. 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% to 4% and 15% to 20%, respectively. there are no adequate and well-controlled studies of tenivac administration in pregnant women in the u.s. there are insufficient human data from tenivac administered during pregnancy to establish the presence or absence of a vaccine-associated risk. a developmental toxicity study has been performed in female rabbits administered a single human dose of tenivac prior to mating and during gestation. this study revealed no evidence of harm to the fetus due to tenivac. (see animal data ) data animal data in a developmental toxicity study, female rabbits received a single human dose (0.5 ml) of tenivac by intramuscular injection 17 and 10 days prior to mating, and on gestation days 6 and 29. 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. it is not known whether tenivac components are excreted in human milk. data are not available to assess the effect of administration of tenivac on breastfed infants or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tenivac and any potential adverse effects on the breastfed child from tenivac or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. tenivac is not approved for use in infants and children younger than 7 years of age. safety and effectiveness of tenivac in this age group have not been established. in one clinical study, (tdc01) 449 participants 65 years of age and over, including 192 participants who were 75 years of age and over received a dose of tenivac. a lower proportion of participants 65 years of age and over had a pre-vaccination seroprotective level of antibody to tetanus toxoid and diphtheria toxin compared to adolescents and adults less than 65 years of age. the proportion of participants 65 years of age and over with a seroprotective level of antibody following tenivac was marginally lower for tetanus and lower for diphtheria compared to younger participants. in general, rates of solicited adverse events were not higher in participants 65 years of age and over compared to younger participants. [see adverse reactions (6) , clinical pharmacology (12.1), and clinical studies (14.2) .]

Stati Uniti - Ingliż - NLM (National Library of Medicine)

merck sharp & dohme llc - hepatitis a virus strain cr 326f antigen (formaldehyde inactivated) (unii: q04q922k9q) (hepatitis a virus strain cr 326f antigen (formaldehyde inactivated) - unii:q04q922k9q) - hepatitis a virus strain cr 326f antigen (formaldehyde inactivated) 25 [iu] in 0.5 ml - vaqta® [hepatitis a vaccine, inactivated] is indicated for the prevention of disease caused by hepatitis a virus (hav) in persons 12 months of age and older. the primary dose should be given at least 2 weeks prior to expected exposure to hav. do not administer vaqta to individuals with a history of immediate and/or severe allergic or hypersensitivity reactions (e.g. , anaphylaxis) after a previous dose of any hepatitis a vaccine, or to individuals who have had an anaphylactic reaction to any component of vaqta, including neomycin [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 designed to evaluate vaqta in pregnant women. available post-approval data do not suggest an increased risk of miscarriage or major birth def

Stati Uniti - Ingliż - 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)] .

Stati Uniti - Ingliż - NLM (National Library of Medicine)

mcm vaccine co. - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37), - vaxelis™ is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, and invasive disease due to haemophilus influenzae (h. influenzae ) type b. vaxelis is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). do not administer vaxelis to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of vaxelis, any ingredient of vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis b vaccine, or h. influenzae type b vaccine [see description (11) .] do not administer vaxelis to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine, that is not attributable to another identifiable cause. do not administer vaxelis to anyone with a history of progressive neurologic disorder, includ

Stati Uniti - Ingliż - NLM (National Library of Medicine)

msp vaccine company - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - vaxelis® is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, and invasive disease due to haemophilus influenzae (h. influenzae ) type b. vaxelis is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). do not administer vaxelis to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of vaxelis, any ingredient of vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis b vaccine, or h. influenzae type b vaccine [see description (11) .] do not administer vaxelis to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine, that is not attributable to another identifiable cause. do not administer vaxelis to anyone with a history of progressive neurologic disorder, inclu

Singapor - Ingliż - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - diphtheria toxoid (d); filamentous haemagglutinin (fha); hib purified capsular polysaccharide; pertactin (prn or 69kda outer membrane protein); pertussis toxoid (pt); polio virus type 1 (inactivated); polio virus type 2 (inactivated); polio virus type 3 (inactivated); tetanus toxoid (t) - injection - min 30iu/0.5ml - diphtheria toxoid (d) min 30iu/0.5ml; filamentous haemagglutinin (fha) 25mcg/0.5ml; hib purified capsular polysaccharide 10 mcg/0.5 ml; pertactin (prn or 69kda outer membrane protein) 8mcg/0.5ml; pertussis toxoid (pt) 25mcg/0.5ml; polio virus type 1 (inactivated) 40du/0.5ml; polio virus type 2 (inactivated) 8du/0.5ml; polio virus type 3 (inactivated) 32du/0.5ml; tetanus toxoid (t) min 40iu/0.5ml