"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"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
FACTOR IX, HUMAN - INJECTION
COMMON BRAND NAME(S): Alphanine SD, Konyne, Proplex T
USES: This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause.
This medication should not be used to reverse the effects of "blood thinners" (e.g., warfarin). Most types of this medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII). If you are using this medication for one of these conditions, consult your doctor or pharmacist to make sure that you are using the right product.
HOW TO USE: This medication is given by injection into a vein as directed by your doctor. Dosage is based on your medical condition (e.g., amount and location of bleeding), weight, and response to treatment.
Gently swirl the medication to mix. Do not shake. Some forms of this medication must be completely mixed into the liquid so that the liquid contains no particles. In these cases, do not use the liquid if it contains particles. Other forms of this medication may occasionally contain a few small particles in the vial, even if the medication is mixed correctly. In these cases, the particles will not affect how well the medication works and will be removed by the filter. If you have questions about whether your form of this medication may be used if it contains particles, or if you have other questions about the use of this medication, consult the doctor or pharmacist.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Learn how to store and discard medical supplies safely.
The medication in the vial and the supplies that come with the medication should be used only once. Do not reuse.
Tell your doctor if your condition persists or worsens.
Additional Proplex-T 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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