OCTAPLAS- human plasma proteins solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

PLASMA PROTEIN FRACTION (HUMAN) (UNII: 6D53G0FD0Z) (PLASMA PROTEIN FRACTION (HUMAN) - UNII:6D53G0FD0Z)

Διαθέσιμο από:

Octapharma USA Inc

INN (Διεθνής Όνομα):

PLASMA PROTEIN FRACTION - UNII:6D53G0FD0Z)

Σύνθεση:

PLASMA PROTEIN FRACTION (HUMAN) 11.5 g in 200 mL

Οδός χορήγησης:

INTRAVENOUS

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Octaplas is supplied in polyvinyl chloride blood bags containing 200 mL frozen solution and has a slightly yellow appearance. Storage and Handling

Καθεστώς αδειοδότησης:

Biologic Licensing Application

Αρχείο Π.Χ.Π.

OCTAPLAS- HUMAN PLASMA PROTEINS SOLUTION
OCTAPHARMA USA INC
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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