Prolastin-C Dosage

Dose

• The recommended dose of PROLASTIN-C LIQUID is 60 mg/kg body weight administered intravenously once weekly.
  
  
• Dose ranging studies using efficacy endpoints have not been performed with any Alpha1-PI product.
  
  
• The carton and the label on each vial of PROLASTIN-C LIQUID show the actual amount of functionally active Alpha1-PI in milligrams (as determined by the capacity to neutralize porcine pancreatic elastase).

Preparation and Handling

1. Allow unopened PROLASTIN-C LIQUID to warm up to room temperature before administration.
   
2. Remove the plastic flip top from the vial.
   
3. Swab the exposed stopper surface with alcohol and allow to dry.
   
4. Inspect the PROLASTIN-C LIQUID visually for particulate matter and discoloration prior to pooling. The product may contain a few protein particles. The solution is clear, colorless or pale yellow or pale green. Do not use if the product is discolored or cloudy.
   
5. Pool PROLASTIN-C LIQUID from several vials to achieve the intended mg/kg body weight dose into an empty, sterile intravenous solution container using aseptic technique.
   
6. Keep pooled solution at room temperature for administration within three hours.

Administration

• Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. The product may contain a few protein particles. Do not use if discolored or cloudy.
• Filter the solution during administration using an intravenous administration set with a suitable 5 to 15 micron infusion filter (not supplied).
• Infuse PROLASTIN-C LIQUID separately, without mixing with other agents or diluting solutions.
• Infuse PROLASTIN-C LIQUID intravenously at 0.08 mL/kg/min as determined by patient response and comfort. The recommended dosage of 60 mg/kg takes approximately 15 minutes to infuse.