Protein C Concentrate (Human)

• It is used to treat very bad protein C deficiency.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

30 minutes

Time to Peak

Plasma: Tmax: 0.5 hours; range: 0.17 to 1.33 hours

Half-Life Elimination

Median: 9.8 hours; range: 4.9 to 14.7 hours

Severe congenital protein C deficiency: Prevention and treatment of venous thrombosis and purpura fulminans in adults and pediatric patients with severe congenital protein C deficiency.

There are no contraindications listed in the manufacturer’s labeling.

At maximum daily doses, product formulation contains sodium >200 mg.

As with all drugs which may affect hemostasis, bleeding may be associated with protein C administration. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables, including the concurrent use of multiple agents that alter hemostasis and patient susceptibility. Frequency not defined.

Central nervous system: Dizziness

Hematologic & oncologic: Hemorrhage

Hypersensitivity: Hypersensitivity reaction (pruritus and rash)

<1% (Limited to important or life-threatening): Fever, hemothorax, hypotension, hyperhidrosis, restlessness