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(Rotavirus Vaccine, Live) for Oral Administration
ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 1060 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus.
The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red.
In the manufacturing process, porcine-derived materials are used. Porcine circovirus type 1 (PCV-1) is present in ROTARIX. PCV-1 is not known to cause disease in humans.
The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluents includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach.
ROTARIX is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral applicator of liquid diluent [see HOW SUPPLIED/Storage and Handling]. The tip caps of the prefilled oral applicators may contain natural rubber latex; the vial stoppers are not made with natural rubber latex. ROTARIX contains no preservatives.
What are the possible side effects of rotavirus oral vaccine (Rotarix, RotaTeq)?
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects. Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the...
What are the precautions when taking rotavirus vaccine, live, oral suspension (Rotarix)?
Before your child takes this vaccine, tell the doctor or pharmacist if your child is allergic to it; or if he/she has any other allergies. This product may contain inactive ingredients (such as latex found in the packaging of some products), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this vaccine, tell your doctor or pharmacist your child's medical history, especially of: current fever/illness, current vomiting/diarrhea, stomach/intestinal problems (such as blockage, intussusception), not gaining weight/growing as expected, blood cancer (such as leukemia, lymphoma), blood disorders (such as hemophilia), immune system problems (such as HIV/AIDS, SCID).
Family or household members with cancer or weakened...
Last reviewed on RxList: 9/26/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Rotarix Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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