Tdvac – Serum International Institute
Indication and Usage –
- Indicated for primary vaccination and revaccination of adults and adolescents having contraindications of Pertussis antigen.
- Primary vaccination and revaccination of children older than 7 years.
Dosage and Administration –
- Intramuscular Injection.
- Two injections of 0.5 ml. at least four weeks apart followed by a third injection 6 to 12 months after the second dose.
- The vaccine should also be given as a booster immunization every 5 to 10 years.
Contraindications –
- A severe allergic reaction (e.g., anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration of MassBiologics’ TDVAX vaccine.
- Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out.
- Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.
Adverse reactions –
- General Disorders and Administration Site Conditions: Injection site reactions, including pain, tenderness, erythema, induration, pruritis, swelling and warmth; peripheral oedema, pyrexia, malaise
- Nervous System Disorders: Dizziness, headache, convulsions
- Musculoskeletal and Connective Tissue Disorders: Myalgia, musculoskeletal stiffness or pain, arthralgia
- Skin and Subcutaneous Tissue Disorders: Rash
- Gastrointestinal Disorders: Nausea
- Infections and Infestations: Cellulitis
Drug interactions and other interactions –
- Patients who are on immunosuppressive therapy, including alkylating agents, antimetabolites, cytotoxic drugs, irradiation, or corticosteroids (used in greater than physiologic doses), may have a reduced immune response to vaccines.
- No safety and immunogenicity data are available on the concomitant administration of MassBiologics’ TDVAX vaccine with other U.S. licensed vaccines.
No studies have been performed with MassBiologics’ TDVAX to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.
