"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"...
Prolastin Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.
This medication is made from human blood. There is a very small chance that you may get infections from this medication (including viral infections such as hepatitis, parvovirus B19), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of hepatitis or other infection, including persistent fever, persistent sore throat, stuffy nose, unusual tiredness, unusual drowsiness, joint pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine.
A very serious allergic reaction to this drug is rare. However, stop receiving the drug and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: hives, rash, itching/swelling (especially of the face/tongue/throat), chest tightness, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Prolastin (alpha) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using alpha-1-proteinase inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have 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 medication, tell your doctor or pharmacist your medical history, especially of: selective IgA deficiency with antibodies to IgA, liver disease, heart problems (such as heart failure).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Since this medication is made from human blood, there is a very small chance that you may get infections from it (such as viral infections like hepatitis). It is recommended that you get the appropriate vaccinations (such as for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent virus infections. Consult your doctor for more details.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Prolastin Information
Prolastin - User Reviews
Prolastin User Reviews
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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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