Monograph Details
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Hematology
> Bleeding disorders
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PROFILNINE SD |
| Manufacturer |
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Grifols Biologicals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Clotting factor. |
| Generic Name |
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Coagulation Factor IX complex (human) 500 IU, 1000 IU, 1500 IU; per vial; lyophilized concentrate for IV infusion after reconstitution; contains Factor X, Factor II, Factor VII; preservative-free. |
| Indications |
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Prevention and control of bleeding in Hemophilia B. |
| Children |
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See literature. |
| Adults |
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See prescribing note for dosing equation. Individualize. Max infusion rate: 10mL/min. Mild to moderate hemorrhage: give single dose to increase Factor IX 20–30%. Serious hemorrhage: give daily infusions to increase Factor IX 30–50%. Surgery: increase Factor IX by 30–50% for at least 1 week post-op. Dental extraction: increase Factor IX to 50% immediately prior to procedure; may give additional doses if bleeding recurs. |
| Precautions |
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Not for treating Factor VII deficiency. Contains human plasma; monitor for possible infection transmission. Liver disease, prolonged treatment duration or if undergoing surgery: increased risk of disseminated intravascular coagulation (DIC) and thrombosis. Pregnancy (Cat.C). |
| Adverse Reactions |
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Urticaria, fever, chills, GI upset, headache, somnolence, lethargy, flushing, tingling; hypersensitivity reactions, thrombosis, DIC. |
| Extra Text |
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Note: Report all infections suspected to be transmitted by Profilnine SD to (888) 675-2762. |
| How Supplied |
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Single-use vials—1 (w. diluent, supplies) |
| Additional Resources |
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• Related Prescribing Note |
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