Diphtheria And Tetanus Toxoids Adsorbed
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Labeling Changes
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Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Diphtheria and Tetanus Toxoids Adsorbed is a sterile, cloudy, white, uniform suspension of diphtheria and tetanus toxoids adsorbed on aluminum phosphate and suspended in isotonic sodium chloride solution for intramuscular injection only. Diphtheria and Tetanus Toxoids Adsorbed vaccine does not contain a preservative.
Each 0.5 mL dose is formulated to contain: 25 Lf diphtheria toxoid and 5 Lf tetanus toxoid. Other ingredients per 0.5 mL dose include: 1.5 mg aluminum phosphate and <100 mcg free formaldehyde.
Diphtheria toxoid is prepared from the toxin produced during the growth of a selected strain of Corynebacterium diphtheriae grown with aeration in submerged culture. The toxin is purified by precipitation, converted to toxoid by the addition of formalin and concentrated by ultrafiltration. The culture medium consists of a tryptic digest of casein, supplemented with cystine, maltose, uracil, inorganic salts and vitamins.
Tetanus toxoid is prepared from the toxin produced during the growth of a selected strain of Clostridium tetani. The toxin is converted to toxoid by the addition of formalin, concentrated and then purified. The culture medium consists of a tryptic digest of casein, supplemented with cystine, dextrose, uracil, inorganic salts and vitamins.
When tested in guinea pigs, the tetanus and diphtheria components induce at least 2 neutralizing units/mL of serum.
The vial stopper is not made with natural rubber latex.
Sources
Diphtheria And Tetanus Toxoids Adsorbed Manufacturers
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Sanofi Pasteur Inc.
![Diphtheria And Tetanus Toxoids Adsorbed (Corynebacterium Diphtheriae Toxoid Antigen (Formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (Formaldehyde Inactivated)) Injection, Suspension [Sanofi Pasteur Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Diphtheria And Tetanus Toxoids Adsorbed | Sanofi Pasteur Inc.
For intramuscular use only.
2.1 Dosage and ScheduleDiphtheria and Tetanus Toxoids Adsorbed is approved for administration as a 5 dose series at 2, 4, 6, 15-18 months, and 4-6 years. The first dose of Diphtheria and Tetanus Toxoids Adsorbed may be administered as early as 6 weeks of age.
2.2 AdministrationParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, the product should not be administered.
After removing the "flip-off" cap, cleanse the vaccine vial stopper with a suitable germicide. Do not remove either the rubber stopper or the metal seal holding it in place. Just before use, shake the vial well until a uniform, white, cloudy suspension results.
Using a sterile needle and syringe and aseptic technique, withdraw and administer a single 0.5 mL dose of Diphtheria and Tetanus Toxoids Adsorbed intramuscularly. Use a separate sterile needle and syringe for each injection. Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Diphtheria and Tetanus Toxoids Adsorbed vaccine should not be combined through reconstitution or mixed with any other vaccine.
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