Rotavac 5D Special Precautions

No safety or efficacy data are available from clinical trials regarding the administration of ROTAVAC 5D to immune-compromised infants, infants infected with HIV or infants with chronic gastroenteritis. Administration of ROTAVAC 5D may be considered with caution in immune-compromised infants and infants in close contact with immune-deficient persons, if in the opinion of the physician, withholding the vaccine entails a greater risk. Similarly, acute infection or febrile illness may be reason for delaying the administration of ROTAVAC 5D, unless in the opinion of the physician, withholding the vaccine entails a greater risk. Low-grade fever and mild upper respiratory tract infection are not contraindications to ROTAVAC 5D.
Available published data shows a small increased incidence of Intussusception (IS) following the first dose of Rotavirus vaccines (WHO position paper, January 2013, http://www.who.int/wer/2013/wer8805.pdf?ua=1). However, the safety data from the clinical trials of ROTAVAC 5D did not show an increased risk or incidence of IS. Yet, it is advised to healthcare providers to look into any symptoms suggestive of IS e.g., continuous vomiting, blood in stools and abdominal lump or distension of the abdomen. Parents/caregivers should be advised promptly to inform such symptoms to healthcare providers.
Similar to other vaccines, vaccination with ROTAVAC 5D may not result in complete protection against rotavirus induced gastroenteritis or gastroenteritis due to other pathogens.
There is no data to support use of ROTAVAC 5D for post exposure-prophylaxis.
*ROTAVAC 5D should not be injected at any circumstances.
Effect on ability to drive and use machines: Not applicable.