"The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
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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 VIIA, RECOMBINANT - INJECTION
COMMON BRAND NAME(S): Novoseven
USES: This medication is used to treat and prevent bleeding in people with certain conditions (hemophilia type A or B patients with antibodies/inhibitors that reduce the activity of clotting factors VIII or IX). It may also be used to treat and prevent bleeding episodes in people born with low levels of factor VII. People with these conditions are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIIa, which is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding.
HOW TO USE: This medication is given by injection into a vein usually over several minutes. The dose is usually repeated every 2 to 6 hours or as directed by your doctor. The dosage is based on your medical condition, weight, and response to treatment.
Do not inject the mixing solution (sterile water for injection) directly into the medication powder because this may cause the medication to become ineffective. Aim the syringe so that the water flows gently down the side of the vial. Do not shake the vial. Gently swirl the mixture until all the powder has dissolved. Do not mix this medication with any other drugs. Use immediately.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
Tell your doctor if your condition does not improve or if it worsens.
Additional Novoseven 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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