Hexaxim – Sanofi
Indication and Usage –
- Hexaxim is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b.
Dosage and Administration –
- Hexaxim should be administered intramuscularly. The recommended injection sites are generally the antero-lateral aspect of the upper thigh in infants and toddlers and the deltoid muscle in older children.
- The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.
- Where a dose of hepatitis B vaccine is given at birth, Hexaxim can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Contraindications –
- Hypersensitivity to the active substances, to any pertussis vaccine, or after previous administration of the vaccine or a vaccine containing the same components or constituents.
- Generally vaccination must be postponed in cases of moderate or severe febrile and/or acute disease. The presence of a minor infection and/or low-grade fever does not constitute a contraindication.
- The vaccination with Hexaxim is contraindicated if the infant has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
- Uncontrolled neurologic disorder or uncontrolled epilepsy: Pertussis vaccine should not be administered to individuals with these conditions until the treatment regimen has been established, the condition has stabilized and the benefit clearly outweighs the risk.
Adverse reactions –
- In clinical studies in individuals who received Hexaxim, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema.
- Slightly higher solicited reactogenicity was observed after the first dose compared to subsequent doses.
Drug interactions and other interactions –
- There may be a clinically relevant interference in the antibody response of Hexaxim and a varicella vaccine and these vaccines should not be administered at the same time.
- If co-administration with another vaccine is considered, immunisation should be carried out on separate injection sites.
- Hexaxim must not be mixed with any other vaccines or other parenterally administered medicinal products.
No significant clinical interaction with other treatments or biological products has been reported except in the case of immunosuppressive therapy.
