Rotarix

DRUG DESCRIPTION

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[8] type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 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. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent 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 (rotavirus vaccine, live, oral suspension) contains no preservatives.

The tip cap and the rubber plunger of the oral applicator contain dry natural latex rubber. The vial stopper and transfer adapter are latex-free.

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 your child receives another vaccine in the future, you will need to tell the doctor if the first dose caused any side effects. Getting rotavirus disease is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects. 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;...

Read All Potential Side Effects and See Pictures of Rotarix

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 to latex (which may be found in the packaging of some brands); or if he/she has any other allergies. This product may contain inactive ingredients, 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/abdominal problems, 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 immune systems may rarely become...

Read All Potential Precautions of Rotarix


Rotarix Consumer (continued)

SIDE EFFECTS: Mild fever/diarrhea/vomiting may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor immediately if any of these unlikely but serious side effects occur: sudden abdominal pain (persistent crying, especially when abdomen is touched), bloody stools, persistent/high fever greater than 102 degrees F.

A very serious allergic reaction to this vaccine is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before your child takes this vaccine, tell the doctor or pharmacist if your child is allergic to it; or to latex (which may be found in the packaging of some brands); or if he/she has any other allergies. This product may contain inactive ingredients, 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/abdominal problems, 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 immune systems may rarely become infected with this virus if they have regular close contact with a child who takes this vaccine. People in close contact with your child should practice good hygiene such as washing hands thoroughly after diaper changes and feedings. Consult the doctor for more details.

This vaccine is not used in adults. Therefore, it is unlikely to be used during pregnancy or by a mother while breast-feeding. Consult the doctor if you have any questions about this vaccine.


Rotarix Patient Information Including Side Effects

Brand Names: Rotarix, RotaTeq

Generic Name: rotavirus oral vaccine, live (oral) (Pronunciation: ROE ta vye ris VAX een)

  • What is rotavirus oral vaccine (Rotarix)?
  • What are the possible side effects of rotavirus oral vaccine (Rotarix)?
  • What is the most important information I should know about rotavirus oral vaccine (Rotarix)?
  • What should I discuss with my health care provider before receiving rotavirus oral vaccine (Rotarix)?
  • How is rotavirus oral vaccine given (Rotarix)?
  • What happens if I miss a dose (Rotarix)?
  • What happens if I overdose (Rotarix)?
  • What should I avoid while taking rotavirus oral vaccine (Rotarix)?
  • What other drugs will affect rotavirus oral vaccine (Rotarix)?
  • Where can I get more information?

What is rotavirus oral vaccine (Rotarix)?

Rotavirus oral vaccine contains up to five strains of rotavirus. It is made from both human and animal sources.

Infection with rotavirus can affect the digestive system of babies and young children, causing severe stomach or intestinal illness.

The rotavirus oral vaccine is used to help prevent this disease in children.

This vaccine works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Rotavirus oral vaccine is for use in children between the ages of 6 weeks and 32 weeks old.

Like any vaccine, the rotavirus oral vaccine may not provide protection from disease in every person.

What are the possible side effects of rotavirus oral vaccine (Rotarix)?

Keep track of any and all side effects your child has after receiving this vaccine. When your child receives another vaccine in the future, you will need to tell the doctor if the first dose caused any side effects. Getting rotavirus disease is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects. 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 face, lips, tongue, or throat.

Call your doctor at once if your child has any of these serious side effects:

  • seizure (black-out or convulsions);
  • high fever, redness of the skin or eyes, swollen hands, peeling skin rash, chapped or cracked lips;
  • cough, wheezing or shortness of breath, chest or stomach pain, weakness, loss of appetite, vomiting, diarrhea;
  • runny or stuffy nose, mild cough, other cold symptoms; or
  • painful or difficult urination.

Other less serious side effects are more likely to occur, such as crying or mild irritability.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rotavirus oral vaccine (Rotarix)?

Keep track of any and all side effects your child has after receiving this vaccine. When your child receives another vaccine in the future, you will need to tell the doctor if the first dose caused any side effects.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Before your child receives this vaccine, tell the doctor if your child has recently had a fever. Also tell the doctor if anyone living with or caring for the child has cancer or a weak immune system, or is receiving treatments that can weaken the immune system (such as radiation, chemotherapy, or steroids).

Always wash your hands after handling the diapers of a child who has been given the rotavirus oral vaccine. Small amounts of the virus may be passed in the child's stool and could possibly infect others who come into contact with the child's stool.

Be sure your child receives all recommended doses of this vaccine. Your child may not be protected from rotavirus if the doses aren't given within 4 to 10 weeks of each other, or if the child does not receive the full series of vaccines.

Avoid receiving the doses of this vaccine in different clinics or from different doctors. Your child should receive the same brand of rotavirus oral vaccine for all doses given. Different brands of this vaccine may not have the same dosing or booster schedule.

Call your doctor as soon as possible if your child (after receiving a rotavirus oral vaccine) has stomach pain or bloating, vomiting (especially if it is golden-brown to green in color), bloody stools, grunting or excessive crying, and eventually weakness and shallow breathing.

Becoming infected with rotavirus is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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  • Rotarix
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