USA - engelsk - 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) .]

USA - engelsk - 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), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml - adacel® is a vaccine indicated for: - active booster immunization against tetanus, diphtheria and pertussis. adacel is approved for use in individuals 10 through 64 years of age. immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to administration of adacel. [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. encephalopathy (e.g., coma, prolonged seizures, or decreased level of consciousness) within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindicatio

USA - engelsk - NLM (National Library of Medicine)

rebel distributors - clostridium tetani (unii: 751e8j54vm) (clostridium tetani - unii:751e8j54vm), corynebacterium diphtheriae (unii: 3u7e3o07s8) (corynebacterium diphtheriae - unii:3u7e3o07s8) - clostridium tetani 2.0 in 0.5 ml - massbiologics' td is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria.  this vaccine is approved for use in persons 7 years of age and older. a severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of massbiologics' td vaccine.  (see description ).  because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out.  alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

Filippinene - engelsk - FDA (Food And Drug Administration)

hipra philippines, inc.; distributor: hipra philippines, inc. - inactivated clostridium perfringens b and e , clostridium novyi a , clostridium septicum a , clostridium chauvoei , clostridium tetani vaccine (vet.) - suspension for injection (im/sc) - formulation: each 2 ml (dose) contains: clostridium perfringens (type b, c, and d) b toxoid .................... > 10 iu/ml clostridium perfringens (type b, c, and d) e toxoid............. >3.5 iu/ml clostridium novyi (type b) a toxoid......... > 2.5 iu/ml clostridium septicum a toxoid ............. clostridium chauvoei ............ ........... 100 % protection clostridium tetani toxoid........... > 2.5 iu/ml

Australia - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - clostridium tetani uf toxoid; thiomersal - misc. vaccines or anti sera - clostridium tetani uf toxoid vaccine-toxoid active 0.0 p; thiomersal mercury other 0.1 mg/ml - immunotherapy - cattle | dog | goat | horse | pigs | sheep | beef | billy | bitch | boar | bos indicus | bos taurus | bovine | buck | buffalo | - tetanus | tetanus vaccination

Australia - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - clostridium tetani - toxoid - unknown - clostridium tetani - toxoid vaccine-toxoid active 0.0 - active constituent

Australia - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - vitamin b12a = hydroxocobalamin; erysipelothrix rhusiopathiae; clostridium perfringens type d toxoid; clostridium tetani uf toxoid; corynebacterium pseudotuberculosis (ovis) - toxoid; thiomersal - misc. vaccines or anti sera - vitamin b12a = hydroxocobalamin vitamin-b12 active 2.0 mg/ml; erysipelothrix rhusiopathiae vaccine-general active 40.0 iu/vial; clostridium perfringens type d toxoid vaccine-toxoid active 5.0 iu/ml; clostridium tetani uf toxoid vaccine-toxoid active 2.5 iu/ml; corynebacterium pseudotuberculosis (ovis) - toxoid vaccine-toxoid active 6.0 cpu/ml; thiomersal mercury other 0.1 mg/ml - immunotherapy

Australia - engelsk - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - streptococcus equi as cell free extract; clostridium tetani uf toxoid; thiomersal - misc. vaccines or anti sera - streptococcus equi as cell free extract vaccine-microbial active 0.0 p; clostridium tetani uf toxoid vaccine-toxoid active 0.0 p; thiomersal mercury other 0.1 mg/ml - immunotherapy - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - strangles | tetanus | tetanus vaccination

USA - engelsk - NLM (National Library of Medicine)

sanofi pasteur inc. - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13) - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml

USA - engelsk - NLM (National Library of Medicine)

massbiologics - 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) 2.0 [lf] in 0.5 ml - massbiologics' tdvax is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. this vaccine is approved for use in persons 7 years of age and older. a severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of massbiologics' tdvax vaccine. (see description ). because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.