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 Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi pasteur msd ltd - human poliovirus type 3 inactivated; tetanus toxoid; pertussis antigens; human poliovirus type 1 inactivated; human poliovirus type 2 inactivated; diphtheria toxoid; haemophilus influenzae type b polysaccharide protein conjugate - suspension for injection

United States - English - 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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international - haemophilus parasuis serotype 5 (inactivated) 200 mg/dose - suspension for injection - haemophilus parasuis 10 mg/ml - actinobacillus/haemophilus vaccine - pig

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

zoetis belgium sa-nv - haemophilus parasuis (inactivated) ; mycoplasma hyopneumoniae (inactivated) - suspension for injection - haemophilus parasuis; mycoplasma hyopneumoniae, inactivated - mycoplasma + haemophilus - pig

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

zoetis belgium sa-nv - haemophilus parasuis (inactivated) ; mycoplasma hyopneumoniae (inactivated) - suspension for injection - haemophilus parasuis; mycoplasma hyopneumoniae, inactivated - mycoplasma + haemophilus - pig

United States - English - 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

Philippines - English - FDA (Food And Drug Administration)

virbac philippines inc.; distributor: virbac philippines inc. - inactivated bordetella bronchiseptica , pasteurella multocida , actinobacillus pleuropneumoniae , mycoplasma hyopneumoniae , streptococcus suis , haemophilus parasuis vaccine (vet.) - suspension for injection (im) - formulation: each 1 ml (dose) contains: bordetella bronchiseptica -1 od bordetella bronchiseptica (dnt)-200 ug/ml pasteurella multocida (type a and d)-i od p. multocida type a (omp)-30 ug/ml actinobacillus pleuropneumoniae (serotype 2 and 5)-1 od p. multocida type d (dnt)-200 ug/ml mycoplasma hvopneumoniae-0.12 od a. pleuropneumoniae serotype 2 and 5 (toxin) 10 ug/ml streptococcus suis (type 2)-0.45 od haemophilus parasuis (serotype 1, 4 and 5)-0.45 od od - optical density at 410 nm absorbance (elisa) dnt – dermonecrotic toxin omp - outer membrane protein

Namibia - English - Namibia Medicines Regulatory Council

serum institute of india ltd - diphtheria, tetanus, ; pertussis, hepatitis b; haemophilus influenzae type b conjugate - injection - each dose of 0.5 ml contains diphtheria ; toxoid ? 30 iu, tetanus toxoid ? 40 iu, ; haemophilus influenzae type b.pertussis

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmabroker sales ltd - haemophilus influenzae type b 1500 million organisms (inactivated "germs"); pneumococcus i,ii,iii 1000 million organisms (inactivated "germs"); staphylococcus aureus 1000 million organisms (inactivated "germs"); streptococcus agalactiae 1000 million organisms (inactivated "germs") - tablet - active: haemophilus influenzae type b 1500 million organisms (inactivated "germs") pneumococcus i,ii,iii 1000 million organisms (inactivated "germs") staphylococcus aureus 1000 million organisms (inactivated "germs") streptococcus agalactiae 1000 million organisms (inactivated "germs") excipient: iron oxide red lactose monohydrate magnesium stearate ox bile povidone purified talc shellac - oral antibacterial prophylaxis of complications of colds.