Contraindications
Hypersensitivity. History of encephalopathy within 7 days with pertussis vaccine, progressive neurologic disorder (e.g. infantile spasms, uncontrolled or progressive epilepsy).
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Special Precautions
Patient with history of Arthus-type hypersensitivity or Guillain-Barre syndrome with tetanus vaccine, bleeding disorders (e.g. thrombocytopenia), hypotonic-hyporesponsive episode or crying for ≥3 hours within 48 hours or seizures within 3 days with pertussis vaccine altered immunosuppression. Children (with personal or family history of seizures). Pregnancy and lactation. Postpone immunisation in patients with acute infection or severe febrile illness. Monitoring Parameters Monitor for anaphylaxis and signs of syncope for 15 minutes after inj.
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Adverse Reactions
Significant: Syncope, Guillain-Barre syndrome, brachial neuritis; apnoea (premature infants).
Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain.
General disorders and administration site conditions: Asthenia, fatigue, malaise, fever, chills, inj site reactions (e.g. pain, oedema, erythema).
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Nervous system disorders: Headache, dizziness, somnolence.
Psychiatric disorders: Irritability.
Skin and subcutaneous tissue disorders: Rashes.
Potentially Fatal: Hypersensitivity or anaphylaxis reaction. |
Drug Interactions
Decrease effect with immunosuppressive agents (e.g. corticosteroids, antimetabolites).
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CIMS Class
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