FACTOR 500 I.U. (KOATE – DVI) (HUMAN) 1 VIAL 5 ML

* Koate-DVI 5 mL. Antihemophilic Factor (Human). NDC 13533-665-30.
* Double Viral Inactivation – Solvent/Detergent Treated – Heat-Treated at 80 degrees C.
* No Preservative. For Intravenous (IV) Administration Only. Sterile – Nonpyrogenic.
* Warning: This product is prepared from large pools of human plasma which may contain the causative agents
& & of hepatitis and other viral diseases. See package insert warnings.
& & Hepatitis Danger: The risk of transmission of hepatitis is present.
& & The patient and physician should discuss the risks and benefits of this product.
* Dosage and Administration: Read enclosed package insert.
* Store at 2-8 degrees C (36-46 degrees F). Do not freeze.
* Reconstitute with 5 mL Sterile Water for Injection, USP. Administer within 3 hours after reconstitution.
* This product when reconstituted contains not more than (NMT) 1500 mcg/mL polyethylene glycol (PEG),
& & NMT 0.05 M glycine, NMT 25 mcg/mL polysorbate 80, NMT 5 mcg/g tri-n-butyl phosphate (TNBP),
& & NMT 3 mM calcium, NMT 1 mcg/mL aluminum, NMT 0.06 M histidine, and NMT 10 mg/mL Albumin (Human).
* If the shrink band is absent or shows any sign of tampering, do not use the product and notify Talecris
& & Biotherapeutics, Inc. immediately.
* Rx only: Caution: U.S. federal law prohibits dispensing without prescription.
* Contents: One bottle of Koate-DVI + 5 mL Sterile Water for Injection, USP + One sterile filter needle +
& & One sterile administration set.
* Talecris Biotherapeutics, Inc. – USA. Imported by: BIOLINX.
* Solvent:
& & – Sterile Water for Injection, USP 5 ml. Provided as a solvent or diluent for injectables. Rx Only.
& & – Not for Multiple Dose Use.
& & – Not suitable for I.V. injection without first being made isotonic.
& & – Sterile – Nonpyrogenic.
& & – Warning: Because there is no preservative present, unused amount should be discarded immediately
& & following withdrawal of any portions of contents.
* Manufactured by: Luitpold Pharmaceuticals, Inc. – USA. Distributed by: Talecris Biotherapeutics, Inc. – USA.