"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Proquad Consumer (continued)
Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.
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 children using this medication do not have serious side effects.
Tell the doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, joint pain/stiffness, seizures with fever.
A very serious allergic reaction to this drug 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 the 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 call Health Canada at 1-866-234-2345.
Read the Proquad (measles mumps rubella varicella vaccine live) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before your child receives this product, tell the doctor or pharmacist if your child is allergic to it; or to eggs; or if your child has any other allergies. This product may contain inactive ingredients (such as neomycin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before receiving this product, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness (such as untreated tuberculosis), bleeding/blood clotting problems (such as hemophilia, low platelets), blood cancer (such as leukemia, lymphoma), immune system problems (such as HIV infection), scheduled organ transplant, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.
There is a small risk that your child may expose others to infection with chickenpox for up to 6 weeks after your child has been vaccinated. If possible, your child should avoid being in the same room with newborn babies (especially if born prematurely), pregnant women who have not had chickenpox, and people with immune system problems.
This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy for at least 3 months after vaccination.
This medication may pass into breast milk. However, it is unlikely to harm a nursing infant. Consult the doctor before breast-feeding.
Additional Proquad 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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