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Rotarix

Rotarix

Live attenuated rotavirus vaccine.
Description: 1 dose (1.5 ml) contains: Live attenuated human rotavirus RIX4414 strain not less than 106.0 CCID50.
Excipients/Inactive Ingredients: Sucrose, di-sodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), sterile water.
Porcine Circovirus type 1 (PCV-1) material has been detected in Rotarix vaccine. PCV-1 is not known to cause disease in animals and is not known to infect or cause disease in humans. There is no evidence that the presence of PCV-1 poses a safety risk.

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Description

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Pharmacotherapeutic group: viral vaccines. ATC code: J07BH01.
Pharmacology: Pharmacodynamics: Protective efficacy: In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] and against uncommon rotavirus genotypes G8P[4] (severe gastro-enteritis) and G12P[6] (any gastroenteritis). All of these strains are circulating worldwide.
The protective efficacy of Rotarix lyophilised formulation against any and severe rotavirus gastro-enteritis was evaluated in Europe, Latin America, Africa and Asia.
Severity of gastro-enteritis was defined according to two different criteria: the Vesikari 20-point scale, which evaluates the full clinical picture of rotavirus gastro-enteritis by taking into account the severity and duration of diarrhoea and vomiting, the severity of fever and dehydration as well as the need for treatment or; the clinical case definition based on World Health Organization (WHO) criteria.

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