Uni 5

Uni 5 Special Precautions


Biological E. Limited


Full Prescribing Info
Special Precautions
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination by a qualified physician.
If any of the following events occur in temporal relation to receipt of this vaccine, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered: Temperature ≥ 40°C within 48 hours, not due to another identifiable cause; Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours; Persistent crying lasting ≥ 3 hours, occurring within 48 hours; Convulsions with or without fever, occurring within 3 days.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse event following DTwP-rHepB-Hib vaccination do not constitute contraindications.
HIV infection is not considered as a contraindication for diphtheria, tetanus, pertussis, Hepatitis-B and Hib vaccination. The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patient on immunosuppressive therapy.
Uni 5 should be administered with caution to subjects with thrombocytopenia, a bleeding disorder since bleeding may occur following intramuscular administration of vaccine to these subjects.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine, 1:1000 adrenaline should be available for immediate treatment if such reaction occurs. For this reason the vaccinee should remain under medical supervision for at least 30 minutes after immunization.
As with other vaccines, the administration of Uni 5 should be postponed in subjects suffering from acute severe febrile illness. The presence of minor infection, however, is not a contraindication for vaccination.
Uni 5 should under no circumstances be administered intravenously.
The vaccine is NOT to be used for the treatment of Diphtheria, Tetanus, Pertussis, Hepatitis-B or Haemophilus influenzae type b infection.
Effects on ability to drive and use machines: Not applicable.
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