Botulism immune globulin is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection caused by botulism toxin type A and B.

Botulism immune globulin is used to treat infant botulism caused by toxin type A or B. botulism immune globulin is used in children who are younger than 1 year old.

Botulism immune globulin may also be used for purposes not listed in this medication guide.

Your baby should not receive botulism immune globulin if he or she has immune globulin A (IgA) deficiency with antibody to IgA.

Your baby should not receive a "live" vaccine (measles, mumps, rubella, polio, rotavirus, yellow fever, varicella) for at least 3 months after receiving botulism immune globulin.

To best participate in the care of your baby while he or she is being treated with botulism immune globulin, carefully follow all instructions provided by your baby's caregivers.

Botulism immune globulin is given as an infusion into a vein. Your baby will receive this infusion in a clinic or hospital setting.

Botulism immune globulin is usually given as a one-time treatment.

Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during the infusion.

To be sure botulism immune globulin is not causing harmful effects, your baby may need follow-up blood tests.

Your baby should not receive botulism immune globulin if he or she has ever had an allergic reaction to an immune globulin, or if the child has immune globulin A (IgA) deficiency with antibody to IgA.

Tell the doctor if your baby has ever had:

• kidney disease;

• diabetes;

• a vaccine;

• dehydration; or

• treatment with any medicines that weaken the immune system.

Botulism immune globulin is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Since botulism immune globulin is used as a single dose, it does not have a daily dosing schedule.

Since botulism immune globulin is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Your baby should not receive a "live" vaccine for at least 3 months after receiving botulism immune globulin. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, or varicella (chickenpox). The vaccine may not work as well during this time, and may not fully protect your baby from disease.

Your baby will remain under constant supervision during treatment with botulism immune globulin.

Get emergency medical help if your baby has signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the baby has:

• tenderness, redness, warmth, cold feeling, or blue/purple appearance in the arms or legs;

• fussiness, trouble breathing, blue lips, pale skin;

• little or no urinating, fewer wet diapers than usual;

• yellowed skin, dark colored urine;

• low levels of sodium in the body--confusion, severe weakness, vomiting, loss of coordination or motor skills; or

• swelling around the brain or spinal cord--fever, neck stiffness, sensitivity to light, weakness, sleepiness, vomiting.

Common side effects of botulism immune globulin may include:

• mild skin rash or redness on the baby's face, chest, back, or stomach;

• chills, body aches;

• wheezing; or

• vomiting.

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.

Other drugs may affect botulism immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.