Rotateq
Loading...Rotateq Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age [see Dosage and Administration (2)].
History
There is currently no drug history available for this drug.
Other Information
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 (serotype P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as serotype P1A[8], from the human rotavirus parent strain and the outer capsid protein of serotype G6 from the bovine rotavirus parent strain (see Table 7).
| Name of Reassortant | Human Rotavirus Parent Strains and Outer Surface Protein Compositions | Bovine Rotavirus Parent Strain and Outer Surface Protein Composition | Reassortant Outer Surface Protein Composition (Human Rotavirus Component in Bold) | Minimum Dose Levels (106 infectious units) |
| G1 | WI79 – G1P1A[8] | WC3 - G6, P7[5] | G1P7[5] | 2.2 |
| G2 | SC2 – G2P2[6] | G2P7[5] | 2.8 | |
| G3 | WI78 – G3P1A[8] | 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.
In the manufacturing process for RotaTeq, a porcine-derived material is used. DNA from porcine circoviruses (PCV) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 are not known to cause disease in humans.
RotaTeq is a pale yellow clear liquid that may have a pink tint.
The plastic dosing tube and cap do not contain latex.
Sources
Rotateq Manufacturers
-
Merck Sharp & Dohme Corp.
![Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent) Solution [Merck Sharp & Dohme Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rotateq | Merck Sharp & Dohme Corp.
FOR ORAL USE ONLY. NOT FOR INJECTION.
The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age [see Clinical Studies (14)].
There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq.
Do not mix the RotaTeq vaccine with any other vaccines or solutions. Do not reconstitute or dilute [see Dosage and Administration (2.2)].
For storage instructions [see How Supplied/Storage and Handling (16.1)].
Each dose is supplied in a container consisting of a squeezable plastic dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch [see Dosage and Administration (2.2)].
2.1 Use with Other VaccinesIn clinical trials, RotaTeq was administered concomitantly with other licensed pediatric vaccines [see Adverse Reactions (6.1), Drug Interactions (7.1), and Clinical Studies (14)].
2.2 Instructions for Use To administer the vaccine: Tear open the pouch and remove the dosing tube. Clear the fluid from the dispensing tip by holding tube vertically and tapping cap. Open the dosing tube in 2 easy motions: 1. Puncture the dispensing tip by screwing cap clockwise
until it becomes tight. 2. Remove cap by turning it counterclockwise. Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty. (A residual drop may remain in the tip of the tube.) If for any reason an incomplete dose is administered (e.g., infant spits or regurgitates the vaccine), a replacement dose is not recommended, since such dosing was not studied in the clinical trials. The infant should continue to receive any remaining doses in the recommended series.
Discard the empty tube and cap in approved biological waste containers according to local regulations.
Login To Your Free Account