Interactions
Co-administration studies have demonstrated that ROTARIX can be given concomitantly with any of the following administered either as monovalent or as combination vaccines: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hexavalent vaccines DTPa-HBV-IPV/Hib, pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine. The studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Clinical studies, involving more than 2,000 subjects, were performed where ROTARIX and oral polio vaccine (OPV) were administered two weeks apart. The immune response to ROTARIX and OPV was unaffected. In three immunogenicity studies, involving approximately 1,200 subjects, ROTARIX was concomitantly administered with OPV. The immune response to OPV, as well as the response to ROTARIX after the second dose, were unaffected. ROTARIX can be concomitantly administered with OPV if this is in accordance with local recommendations. In the absence of local recommendations, an interval of two weeks between the administration of OPV and ROTARIX should be respected.
Although antibodies to rotavirus may be detected in breast milk, the available data show no reduction in efficacy when ROTARIX is administered to breast-fed infants.
ADVERSE REACTIONS
Adverse reactions are thought of as very common if they affect more than one in 10 people, common if they affect more than one in 100 but less than one in 10, uncommon if they affect more than one in 1000 but less than one in 100, rare if they affect more than one in 10,000 but less than one in 1000 and very rare if they affect less than one in 10,000.
Gastrointestinal disorders:
Common: diarrhoea
Uncommon: flatulence, abdominal pain
Skin and subcutaneous tissue disorders:
Uncommon: dermatitis.
(VAN’s Note: This vaccine is to protect against diarrhoea and it’s most common side-effect is diarrhoea).
