tPa-
simultaneous administration of protein C concentrate and tPA  may further increase the risk of
bleeding from tPA.

Severe congenital protein C deficiency

Most serious and common adverse reactions- 
 hypersensitivity ,    allergic reactions (itching and rash ),  lightheadedness

Special precautions-

Transmission of infectious agents-   Protein C concentrate  is made from human plasma. Products
made from human plasma may contain infectious agents, such as virus, that can cause disease.
The risk that such products will transmit an infectious agent has been reduced by screening plasma
donors for prior exposure to certain virus and by carrying out the required testing process.

The  symptoms of infections may include low grade fever, nausea, vomiting and abdominal pain.
Dark urine and yellowed complexation are also common symptoms. Encourage patients to consult
their health care provider if such symptoms appear.

Bleeding episodes- several bleeding episodes have been observed. Concurrent anticoagulant
medication may have been responsible for bleeding episodes. Concurrent admin of protein
C concentrate  may also further contribute to the bleeding events.

Heparin-induced thrombocytopenia HIT - protein C concentrate contain trace amount of heparin
that may lead to HIT. Determine the platelet count immediately  and consider discontinuation
of  protein C concentrate

Low -sodium diet- inform patients on a  low-sodium diet that the quantities of sodium in the maximum
daily dose of protein C conentrate  exceeds 200mg. Closely monitor patients with renal function
impairment for sodium overload.

Hypersensitivity reactions- if symptoms of hypersensitivity/ allergic  reactions occur, discontinue
the injection/infusion. In case of anaphylactic shock, the current medical standards for treatment
are to be observed. 

Pregnancy-  protein C concentrate has not been studied for use in pregnancy. It is not known
whether protein C concentrate can affect reproduction capacity. Observe caution.

Labor and delivery-  protein  C concentrate has not been studied for use during labor and delivery.
However, there has been one report of protein C concentrate exposure  during labor and delivery
with no adverse effects.

Lactation- protein C concentrate has not not been studied for use in breast feeding mothers.

Children- neonatal and pediatric subjects were included in several retrospective and prospective
studies evaluating the safety and efficacy of protein C concentrate. Subjects were enrolled from
as early as 2 days of age throughout adolescence.

Monitoring- closely monitor patients with renal function impairment for sodium overload.

Indication-
Severe congenital protein C deficiency

Dosage-
An initial dosage of 100 to 120 units/kg for determination of recovery and half-life is recommended
for acute episodes and short term prophylaxis.

Subsequently the dose should be adjusted  to maintain a target peak protein C  activity of 100%.
After resolution of the acute episode continue the patient on the same dose to maintain through
protein C activity level above 25% for the duration of the treatment

1. Inform  patients of the early signs of hypersensitivity reactions, including hives, generalized
    urticaria , tightness of the chest, wheezing, hypotension, and anaphylaxis, because the risk of
    allergic type hypersensitivity reactions cannot be exclded.

2. If symptoms of hypersensitivity reactions occur patients should immediately discontinue the
   injection/infusion  and inform their health care as soonas possible,

3. Prior to reconstitution , protect protein C concentrate from light.

4. Reconstitute the lyophillzed protein C concentrate powder with the diluent suppled using the sterile
    transfer needle. Gently swirl the vial until all of the powder is dissolved 

5. The reconstituted solution concentrate does not contain any presrvative. All unused solution ,
    empty vials, and used needle must be discarded appropiately.

Pharmacology-
Protein c concentrate is the prcursor of  a Vitamin K-dependent  anticoagulant glycoprotein
( serine protease ) that is synthesised in the liver.

It is converted by the thrombin/throbomodulin -complex and the endothrlial cell surface to activated
protein c (APC) . APC is a serine protease with potent anticoagulant effects.  

Pregnancy- 
Protein C concentrate has not been studied for use in pregnancy. It is not known
whether protein C concentrate can affect reproduction capacity. Observe caution.

Labor and delivery- 
Protein  C concentrate has not been studied for use during labor and delivery.
However, there has been one report of protein C concentrate exposure  during labor and delivery
with no adverse effects.

Lactation-
Protein C concentrate has not not been studied for use in breast feeding mothers.

Children-
Neonatal and pediatric subjects were included in several retrospective and prospective
studies evaluating the safety and efficacy of protein C concentrate. Subjects were enrolled from
as early as 2 days of age throughout adolescence.