Spojené státy - angličtina - 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) .]

Spojené státy - angličtina - 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

Spojené státy - angličtina - NLM (National Library of Medicine)

sanofi pasteur inc. - 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 - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 15 [lf] in 0.5 ml - daptacel® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday). a severe allergic reaction (e.g., anaphylaxis) after a previous dose of daptacel or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine is a contraindication to administration of daptacel. [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, 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 is a contraindication to administration of any pertussis-containing vaccine, inclu

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; tetanus toxoid, quantity: 20 lfu/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis filamentous haemagglutinin, quantity: 5 microgram; pertussis toxoid, quantity: 2.5 microgram; pertussis fimbriae 2 + 3, quantity: 5 microgram; pertactin, quantity: 3 microgram; tetanus toxoid, quantity: 20 iu - injection, suspension - excipient ingredients: glutaral; formaldehyde; phenoxyethanol; water for injections; aluminium phosphate - adacel is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

Kanada - angličtina - Health Canada

connaught laboratories ltd. - diphtheria toxoid - liquid - 0.2lf - diphtheria toxoid 0.2lf - toxoids

Kanada - angličtina - Health Canada

aventis pasteur limited - diphtheria toxoid - liquid - 50lf - diphtheria toxoid 50lf - toxoids

Kanada - angličtina - Health Canada

aventis pasteur limited - diphtheria toxoid - liquid - 4lf - diphtheria toxoid 4lf - toxoids

Kanada - angličtina - Health Canada

aventis pasteur limited - diphtheria toxoid; tetanus toxoid; pertussis vaccine - liquid - 25lf; 5lf; 12unit - diphtheria toxoid 25lf; tetanus toxoid 5lf; pertussis vaccine 12unit - toxoids