Israel - English - Ministry of Health

medici ltd - diphtheria toxoid 15 lf / 0.5 ml; filamentous haemogglutinin (fha) 5 mcg / 0.5 ml - suspension for injection - hemophilus influenzae b, combinations with pertussis and toxoids - primary vaccination of infants, at or above the age of two months and as a booster in children up to their 6th birthday against diphtheria, tetanus, pertussis and invasive haemophilus influenzae type b infection.

United States - English - 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) .]

United States - English - 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) - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 25 [lf] in 0.5 ml - diphtheria and tetanus toxoids adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. diphtheria and tetanus toxoids adsorbed is approved for use in children from 6 weeks through 6 years of age (prior to 7th birthday). diphtheria and tetanus toxoids and acellular pertussis vaccine (dtap) or a dtap-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. diphtheria and tetanus toxoids adsorbed should be used in instances where the pertussis vaccine component is contraindicated. diphtheria and tetanus toxoids adsorbed is not to be used for treatment of diphtheria or tetanus infection. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of diphtheria and tetanus toxoids adsorbed or any other diphtheria toxoid or tetanus toxoid-containing vaccine, or any other component of this vaccine is a contraindication to administration of diphtheria and tetanus toxoids adsorbed. [see description (11). ] diphtheria and tetanu

Kenya - English - Pharmacy and Poisons Board

biological e. ltd 18 / 1 & 3, azamabad, hyderabad, telangana - - diphtheria and tetanus vaccine (adsorbed, reduced… - suspension for injection - diphtheria toxoid 2 lf (>/ 2 iu), tetanus toxoid… - tetanus toxoid combinations with diphtheria toxoid

United States - English - 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 - quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. a single dose of quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (dtap) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (ipv) vaccination series in children 4 through 6 years of age whose previous dtap vaccine doses have been with pentacel® [diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine], daptacel® (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) and/or vaxelis (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine). severe allergic reaction (e.g., anaphylaxis) to any ingredient of quadracel [see description (11) ] or following any diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovi

Canada - English - Health Canada

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

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

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

seqirus pty ltd - diphtheria toxoid, quantity: 4 iu/ml; tetanus toxoid, quantity: 40 iu/ml - injection, suspension - excipient ingredients: water for injections; sodium hydroxide; aluminium hydroxide hydrate; sodium chloride - vaccination of children (greater than or equal to 5 years of age) and adults who have previously received at least 3 doses of a vaccine for primary immunisation against diphtheria and tetanus. adt booster is not intended for primary immunisation against diphtheria and tetanus. use of adt booster should be scheduled in accordance with official national recommendations.

Australia - English - 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.

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - diphtheria toxoid, tetanus toxoid - suspension for injection - diphtheria toxoid tetanus toxoid - vaccines