Usual Adult Dose for Shock

Replacement of coagulation factors in patients with acquired deficiencies:

• Initially infuse of 10 to 15 mL/kg; this should increase the patient's plasma coagulation factor levels by approximately 15% to 25%; if hemostasis is not achieved, use higher doses
• Adjust dose based on desired response.

Plasma exchange in patients with TTP:

• Completely replace plasma volume removed during plasmapheresis; generally, 1 to 1.5 plasma volumes correspond to 40 to 60 mL/kg

Comments:

• Administer this drug based on ABO-blood group compatibility.
• Dose should be based on the individual patient and response to therapy.
• Rate should be adjusted or slowed according to clinical response and rising blood pressure.

Uses: Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease, undergoing cardiac surgery and liver transplantation, or plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)

Usual Pediatric Dose for Shock

Replacement of coagulation factors in patients with acquired deficiencies:

• Initially infuse of 10 to 15 mL/kg; this should increase the patient's plasma coagulation factor levels by approximately 15% to 25%; if hemostasis is not achieved, use higher doses
• Adjust dose based on desired response.

Plasma exchange in patients with TTP:

• Completely replace plasma volume removed during plasmapheresis; generally, 1 to 1.5 plasma volumes correspond to 40 to 60 mL/kg

Comments:

• Administer this drug based on ABO-blood group compatibility.
• Dose should be based on the individual patient and response to therapy.
• Rate should be adjusted or slowed according to clinical response and rising blood pressure.

Uses: Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease, undergoing cardiac surgery and liver transplantation, or plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein
• IgA deficiency
• Severe deficiency of Protein S (5)

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer this drug based on ABO-blood group compatibility.
• Administer this drug after thawing using an infusion set with a filter.
• This drug should be administered by IV infusion after thawing.
• After thawing the solution is clear to slightly opalescent and free of solid or gelatinous particles.
• Citrate toxicity can occur when more than 0.02 to 0.025 mmol citrate per kg per minute is administered; therefore, the infusion rate should not exceed 1 mL/min.
• Toxic effects of citrate can be minimized by giving calcium gluconate iv into another vein.

Storage requirements:

• Store at -18C (-0.4F) for 3 years from the date of manufacture.
• Protect from light.

Reconstitution/preparation techniques:

• Thaw product according to instructions in the manufacturer product information.
• Use thawed product within 24 hours.
• Do not refreeze thawed product.
• The manufacturer product information should be consulted.

General:

• Solutions that are turbid should not be used.
• Solutions that have been frozen should not be used.
• Administration should not begin more than 4 hours after the container has been entered.
• Partially used or previous entered vials should be discarded.