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ROTATEQ ROTA VIRUS VACCINE 2ML EA

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ROTATEQ ROTA VIRUS VACCINE 2ML EA

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ROTATEQ ROTA VIRUS VACCINE 2ML EA

RotaTeq is a viral vaccine that is used in infants for the prevention of gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection. This vaccine is available only from your doctor or immunisation clinic.

RotaTeq is a live, oral pentavalent reassortant vaccine for use in the prevention of rotavirus gastroenteritis. Each 2 mL dose contains the following rotavirus reassortants: G1, G2, G3, G4, and P1A[8] derived from rotaviruses infecting human and bovine species. The minimum dose levels of the reassortants are as follows:

G1 2.2 X 106 infectious units
G2 2.8 X 106 infectious units
G3 2.2 X 106 infectious units
G4 2.0 X 106 infectious units
P1A[8] 2.3 X 106 infectious units

The reassortants are propagated in Vero cells using standard tissue culture techniques in the absence of antifungal agents.

The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium
hydroxide, polysorbate 80 and also culture media. There are no preservatives or thiomersal present.

RotaTeq is a pale yellow clear liquid that may have a pink tint.

The manufacture of this product includes exposure to bovine derived material. No evidence exists that any case of vCJD (considered to be the human form of bovine
spongiform encephalopathy) has resulted from the administration of any vaccine product.

DNA fragments from porcine circoviruses (PCV) 1 and 2 have been detected in RotaTeq.
The source is porcine-derived material used in the manufacture of the vaccine. PCV-1
and PCV-2 are not known to cause disease in humans.


Additional Information

SKU CSL80750101