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PROFILNINE SD
Bleeding disorders
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Drug Name:

PROFILNINE SD Rx

Generic Name and Formulations:
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.

Company:
Grifols Biologicals, Inc.

Therapeutic Use:

Indications for PROFILNINE SD:

Prevention and control of bleeding in Hemophilia B.

Adult:

Dosage Required (IU) = Body Weight (kg) × Desired Factor IX increase × 1 IU/kg. 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.

Children:

See literature.

Warnings/Precautions:

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).

Pharmacological Class:

Coagulation factor complex.

Adverse Reactions:

Urticaria, fever, chills, GI upset, headache, somnolence, lethargy, flushing, tingling; hypersensitivity reactions, thrombosis, DIC.

Note:

Report all infections suspected to be transmitted by Profilnine SD to (888) 675-2762.

How Supplied:

Single-use vials—1 (w. diluent, supplies)

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