Diphtheria, Tetanus and Pertussis, Triple Vaccine (Adsorbed) I.P.

1. DESCRIPTION:
   Diphtheria, Tetanus and Pertussis , Triple Vaccine (Adsorbed) I.P. is a preparation of Diphtheria formol toxoid, Tetanus formol toxoid adsorbed on aluminium phosphate gel and a suspension of killed Bordetella pertussis organism. Thiomersal is used as preservative. The potency of the vaccine components per single human dose is at least 30 IU for Diphtheria, 40 IU for Tetanus and 4 IU for Pertussis.
2. COMPOSITION:
   Each single dose (0.5ml) contains:
       Diphtheria Toxoid : 20 to 30 Lf.
       Tetanus Toxoid : 5 to 25 Lf.
       Pertussis : > or =4.0 I.U.
       Aluminium : < or =1.25 mg
       Thiomersal : 0.01 %
3. STORAGE:
   At +2-8 ⁰C and should not be allowed to freeze.
4. EXPIRY:
   24 months.
5. TREATMENT / INDICATIONS
   Diphtheria and Tetanus Toxoid and Pertussis Vaccine (Adsorbed) is recommended for active immunization of children up to age 7 years against diphtheria, tetanus, and pertussis (whooping cough). Immunization should be started at 6 weeks to 2 months of age and be completed before the seventh birthday.
6. PRECAUTIONS
   • Shake vial well before withdrawing each dose. Vaccine contains a bacterial suspension. Vigorous agitation is required to re-suspend the contents of the vial. Discard if vaccine cannot be re-suspended.
   • Do not freeze the contents of the vial
   • Protect the vaccine vial from light
   • Allergic reactions with component of product should be borne in mind
   • Separate sterile syringe should be used for each individual.
7. POSOLOGY AND ADMINISTRATION
   • DOSE: Inject 0.5 mL intramuscularly only. The preferred injection sites are the anterolateral aspect of the thigh and the deltoid muscle of the upper arm.
   • PRIMARY IMMUNIZATION: Three doses at 6, 10 & 14 week of age.
   • BOOSTER IMMUNIZATION: Two booster dose at 16-24 month and 5-6 years of age
8. PRESENTATION:
   5 ml vial (10 doses)
9. CONTRAINDICATIONS:
   • Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component
   • For Pertussis-containing vaccines: encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) not attributable to another identifiable cause within 7 days of administration of a previous dose of DTP.
   • In instances where the pertussis vaccine component is contraindicated, or where the physician decides that pertussis vaccine is not to be administered, DT should be used.
   • History of Arthus-type hypersensitivity reactions after a previous dose of tetanus or diphtheria toxoid-containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus-toxoid containing vaccine
10. ADVERSE REACTIONS (IF ANY)
    • MILD PROBLEMS (Common): Fever; Redness or swelling; Soreness or tenderness at the site of injection; Irritability; Fussiness; Tiredness or poor appetite; Nausea.
    • MODERATE PROBLEMS (Uncommon):  Seizure; High fever, over 105⁰F.
    • SEVERE PROBLEMS (Very Rare):  Serious allergic reaction
11. VACCINE VIAL MONITORING (If APPLICABLE) VVM used
    VVM-14