Prefilled syringe containing white suspension in which white pallet and colorless and transparent supernatant are observed when stored

Diphtheria toxoid (strain name: Mass 8 strains), pertussis toxoid (strain name: Tohama strain, phase 1), inactivated pertussis 69kDa outer membrane protein (strain name: Tohama strain, phase 1), inactivated pertussis filamentous hemagglutinin (strain name: Tohama strain, phase 1), tetanus toxoid (strain name: Massachusetts strain)

Prevention of diphtheria, tetanus and pertussis in children 10 years of age or older and adults

• 1 booster dose shall be given for children at 10 years of age or older and adults who have completed all recommended vaccination schedule of diphtheria/tetanus/toxoid and purified pertussis combination vaccine (DTaP) for children during infancy and childhood. However, for individuals who received a vaccine containing diphtheria/tetanus/toxoid should avoid receiving this vaccine within 5 years after the vaccination.
• Injection a single dose (0.5 mL) intramuscularly into deltoid muscle, and do not inject intravascularly.
• Mix sufficiently before use.
• In case of having wound that is prone to autologous tetanus that requires tetanus toxoid (e.g., wound contaminated with dust, feces, soil and saliva; penetrating injury, etc.), this vaccine may be used as an adult diphtheria-tetanus vaccine if the individual has not been vaccinated with tetanus toxoid within 5 years.
  (Note: This vaccine cannot be used for basic vaccinations for infant and child. In other words, the standard vaccination for infancy and childhood should use DTaP for children.)
• For infants aged 7-23 months who have not been vaccinated, give 2-dose series with 0.5 mL each.
  The second dose should be given at an interval of 3 months or longer after the first dose and when the infants are at 1 year of age or older.
  • For children aged 2 years or older to adults aged 55 years or younger, administer 0.5 mL once.
• The necessity and timepoint of booster dose of this vaccine have not been decided yet.

1 prefilled syringe/box [prefilled syringe (0.5 mL)], 10 prefilled syringe/box [prefilled syringe (0.5 mL)], single-use needle attached

• 1) Keep refrigerated (2-8°C) away from light.
• 2) Do NOT freeze. Dispose if frozen.
• 3) This vaccine is stable only for 8 hours at 21°C once removed from the fridge.