Overdose : מינון יתר

12    OVERDOSAGE
There have been post-marketing reports of infants who received more than one dose or a replacement dose of RotaTeq after regurgitation [see Dosage and Administration (5.2)]. In limited post-marketing experience of reported overdosage, the adverse events reported after incorrect administration of higher than recommended doses of RotaTeq were similar to adverse events observed with the approved dosage and schedule.

13    DESCRIPTION
RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as type P1A[8], from the human rotavirus parent strain and the outer capsid protein of type G6 from the bovine rotavirus parent strain (see Table 7).
Table 7
Human Rotavirus       Bovine Rotavirus       Reassortant Outer Surface Parent Strains       Parent Strain and        Protein Composition
Name of       and Outer Surface     Outer Surface Protein      (Human Rotavirus         Minimum Dose Levels Reassortant   Protein Compositions       Composition           Component in Bold)        (106 infectious units) G1           WI79 – G1P1A[8]                                      G1P7[5]                      2.2 G2            SC2 – G2P2[6]                                       G2P7[5]                      2.8 G3           WI78 – G3P1A[8]        WC3 - G6, P7[5]               G3P7[5]                      2.2 G4            BrB – G4P2[6]                                       G4P7[5]                      2.0 P1A[8]        WI79 – G1P1A[8]                                     G6P1A[8]                      2.3 
The reassortants are propagated in Vero cells using standard cell 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, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives.
RotaTeq is a pale yellow clear liquid that may have a pink tint.
The plastic dosing tube and cap are not made with natural rubber latex.