Country: United States
Language: English
Source: NLM (National Library of Medicine)
PLASMA PROTEIN FRACTION (HUMAN) (UNII: 6D53G0FD0Z) (PLASMA PROTEIN FRACTION (HUMAN) - UNII:6D53G0FD0Z)
Octapharma USA Inc
PLASMA PROTEIN FRACTION - UNII:6D53G0FD0Z)
PLASMA PROTEIN FRACTION (HUMAN) 11.5 g in 200 mL
INTRAVENOUS
Octaplas is a solvent / detergent (S/D) treated, pooled human plasma indicated for: - Replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP) Do not use Octaplas in patients with: - IgA deficiency - Severe deficiency of Protein S - History of hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein - History of hypersensitivity reaction to Octaplas Risk Summary Animal reproduction studies have not been conducted with Octaplas. It is not known whether Octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Octaplas should be given to a pregnant woman only if clearly needed. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background
Octaplas is supplied in polyvinyl chloride blood bags containing 200 mL frozen solution and has a slightly yellow appearance. Storage and Handling
Biologic Licensing Application
OCTAPLAS- HUMAN PLASMA PROTEINS SOLUTION OCTAPHARMA USA INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OCTAPLAS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OCTAPLAS. OCTAPLAS, POOLED PLASMA (HUMAN), SOLVENT/DETERGENT TREATED SOLUTION FOR INTRAVENOUS INFUSION INITIAL U.S. APPROVAL: 2013 INDICATIONS AND USAGE Octaplas is a solvent/detergent (S/D) treated, pooled human plasma indicated for (2) • Replacement of multiple coagulation factors in patients with acquired deficiencies (2) • due to liver disease (2) • undergoing cardiac surgery or liver transplantation (2) • Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP) (2) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE ONLY. (3) Administer Octaplas based on AB0-blood group compatibility. (3) Indication Dosage Replacement of multiple coagulation factors in patients with acquired deficiencies 10 to 15 milliliters per kg, Adjust the dose based on the desired clinical response Plasma exchange in patients with TTP 1 to 1.5 plasma volumes (40 to 60 milliliters per kg) DOSAGE FORMS AND STRENGTHS Solution for infusion containing 45 to 70 mg human plasma protein per mL in a 200 mL volume. ( 3 ) CONTRAINDICATIONS • IgA deficiency (5) • Severe deficiency of Protein S (5) • History of hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein (5) • History of hypersensitivity reaction to Octaplas (5) WARNINGS AND PRECAUTIONS • Transfusion reactions can occur with ABO blood group mismatch ( 5.1 ) • High infusion rates can induce hypervolemia with consequent pulmonary edema or heart failure ( 5.2 ) • Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha 2-antiplasmin ( 5.3 ) • Thrombosis can occur due to low levels of Protein S ( 5.4 ) • Citrate toxicity can occur with volumes exceeding one milliliter of Octaplas per kg per minute ( 5.5 ) • Octaplas is made from human blood Read the complete document