Usual Adult Dose for Shock

Initial dose: 20 mL/kg IV during the first 24 hours
Maintenance dose: 10 mL/kg IV per day
Maximum dose: 20 mL/kg IV per day
Duration of therapy: Should therapy continue beyond 24 hours, subsequent doses should not exceed 10 mL/kg IV per day and therapy should not continue beyond 5 days.

Comments:

• The first 10 mL/kg IV may be infused as rapidly as necessary to result in improvement.
• Monitor central venous pressure frequently during the initial infusion.

Use: For use in the adjunctive treatment of shock or impending shock due to hemorrhage, burns, surgery, or other trauma (this drug is not indicated as a replacement for whole blood or blood components if they are available and it should not replace other forms of therapy known to be of value in the treatment of shock)

Usual Adult Dose for Deep Vein Thrombosis

Initial dose: 10 to 20 mL of a 10% solution (1 to 2 g) per kg are added to the perfusion circuit
Maximum dose: 2 g/kg IV

Comments:

• The dose of this drug will vary with the volume of the pump oxygenator.
• This drug can serve as a sole primer or as an additive to other priming fluids.

Use: For use as a priming fluid, either as a sole prime or as an additive, in pump oxygenators during extracorporeal circulation

Usual Adult Dose for Pulmonary Thromboembolism

Initial dose: 10 to 20 mL of a 10% solution (1 to 2 g) per kg are added to the perfusion circuit
Maximum dose: 2 g/kg IV

Comments:

• The dose of this drug will vary with the volume of the pump oxygenator.
• This drug can serve as a sole primer or as an additive to other priming fluids.

Use: For use as a priming fluid, either as a sole prime or as an additive, in pump oxygenators during extracorporeal circulation

Usual Adult Dose for Venous Thromboembolism

Initial dose: 500 to 1000 mL (approximately 10 mL/kg) IV administered on the day of operation
Maintenance dose: 500 mL daily IV for an additional 2 to 3 days, then according to the risk of complications, 500 mL IV may be given every second or third day during the period of risk
Duration of therapy: Up to 2 weeks

Comment:

• The dose of this drug should be chosen according to the risk of thromboembolic complications.

Use: For use in prophylaxis of venous thrombosis and pulmonary embolism in patients undergoing procedures known to be associated with a high incidence of thromboembolic complications (e.g., hip surgery)

Usual Pediatric Dose for Shock

1 month to less than 12 months:
5 mL/kg IV

1 year to adolescent:
10 mL/kg IV

Adolescents:
Initial dose: 20 mL/kg IV during the first 24 hours
Maintenance dose: 10 mL/kg IV per day
Maximum dose: 20 mL/kg IV per day
Duration of therapy: Should therapy continue beyond 24 hours, subsequent doses should not exceed 10 mL/kg per day and therapy should not continue beyond 5 days.

Comments:

• The first 10 mL/kg IV may be infused as rapidly as necessary to result in improvement.
• Monitor central venous pressure frequently during the initial infusion.

Use: For use in the adjunctive treatment of shock or impending shock due to hemorrhage, burns, surgery, or other trauma (this drug is not indicated as a replacement for whole blood or blood components if they are available and it should not replace other forms of therapy known to be of value in the treatment of shock)

Usual Pediatric Dose for Deep Vein Thrombosis

1 month to less than 12 months:
5 mL/kg IV

1 year to adolescent:
10 mL/kg IV

Adolescents:
Initial dose: 10 to 20 mL of a 10% solution (1 to 2 g) per kg are added to the perfusion circuit
Maximum dose: 2 g/kg IV

Comments:

• The dose of this drug will vary with the volume of the pump oxygenator.
• This drug can serve as a sole primer or as an additive to other priming fluids.

Use: For use as a priming fluid, either as a sole prime or as an additive, in pump oxygenators during extracorporeal circulation

Usual Pediatric Dose for Pulmonary Embolism

1 month to less than 12 months:
5 mL/kg IV

1 year to adolescent:
10 mL/kg IV

Adolescents:
Initial dose: 10 to 20 mL of a 10% solution (1 to 2 g) per kg are added to the perfusion circuit
Maximum dose: 2 g/kg IV

Comments:

• The dose of this drug will vary with the volume of the pump oxygenator.
• This drug can serve as a sole primer or as an additive to other priming fluids.

Use: For use as a priming fluid, either as a sole prime or as an additive, in pump oxygenators during extracorporeal circulation

Usual Pediatric Dose for Venous Thromboembolism

1 month to less than 12 months:
5 mL/kg IV

1 year to adolescent:
10 mL/kg IV

Initial dose: 500 to 1000 mL (approximately 10 mL/kg) IV administered on the day of operation
Maintenance dose: 500 mL daily IV for an additional 2 to 3 days, then according to the risk of complications, 500 mL IV may be given every second or third day during the period of risk
Duration of therapy: Up to 2 weeks

Comment:

• The dose of this drug should be chosen according to the risk of thromboembolic complications.

Use: For use in prophylaxis of venous thrombosis and pulmonary embolism in patients undergoing procedures known to be associated with a high incidence of thromboembolic complications (e.g., hip surgery)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• In patients with marked hemostatic defects of all types (e.g., thrombocytopenia, hypofibrinogenemia) including those caused by drugs (e.g., heparin, warfarin)
• Marked cardiac decompensation
• Renal disease with severe oliguria or anuria

Safety and efficacy have not been established in patients younger than 1 month.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer by intravenous (IV) infusion only
• Administration set should include a filter
• Do not use if crystallization has occurred

Storage requirements:

• Store at 20C to 25C (68F to 77F).
• Protect from freezing.

Reconstitution/preparation techniques:

• To open tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect solution quality or safety. The opacity will diminish gradually.
• Use aseptic technique:

1) Close flow control clamp of administration set.
2) Remove cover from outlet port at bottom of container.
3) Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. Note: See full directions on administration set carton.
4) Suspend container from hanger.
5) Squeeze and release drip chamber to establish proper fluid level in drip chamber.
6) Open flow control clamp and clear air from set. Close clamp.
7) Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
8) Regulate rate of administration with flow control clamp.

• WARNING: Do not use flexible container in series connections.