Prolastin-C Dosage

Generic name: alpha-1-proteinase inhibitor human

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For intravenous use only.

The recommended dose of PROLASTIN-C is 60 mg/kg body weight administered once weekly. Dose ranging studies using efficacy endpoints have not been performed with any alpha1-proteinase inhibitor product. Each vial of PROLASTIN-C contains the labeled amount of functionally active Alpha1-PI in milligrams (as determined by the capacity to neutralize porcine pancreatic elastase) as stated on the label.

PROLASTIN-C should be given intravenously at a rate of approximately 0.08 mL/kg/min as determined by the response and comfort of the patient. The recommended dosage of 60 mg/kg takes approximately 15 minutes to infuse.

Preparation and Handling

  • Do not freeze. Breakage of the diluent bottle may occur.
  • PROLASTIN-C and diluent should be at room temperature before reconstitution.
  • Inspect reconstituted PROLASTIN-C visually for particulate matter and discoloration prior to pooling and use.
  • PROLASTIN-C should be kept at room temperature after reconstitution and should be administered within 3 hours.
  • PROLASTIN-C should be given alone, without mixing with other agents or diluting solutions.
  • Reconstituted product from several vials may be pooled into an empty, sterile IV solution container by using aseptic technique.
  • Do not use after expiration date.

Administration

Each product package contains one PROLASTIN-C single use vial, one 20 mL vial of Sterile Water for Injection (diluent), one color-coded sterile transfer needle, and one sterile filter needle. Administer within three hours after reconstitution.

Reconstitution

Use aseptic technique.

  1. PROLASTIN-C and diluent should be at room temperature before reconstitution.
  2. Remove the plastic flip tops from each vial.
  3. Swab the exposed stopper surfaces with alcohol and allow surface to dry.
  4. Remove the plastic cover from the short end of the transfer needle. Insert the exposed end of the needle through the center of the stopper in the DILUENT vial.
  5. Remove the cover at the other end of the transfer needle by twisting it carefully.
  6. Invert the DILUENT vial and insert the attached needle into the PRODUCT vial at a 45° angle (Figure A below). This will direct the stream of diluent against the wall of the product vial and minimize foaming. The vacuum will draw the diluent into the PRODUCT vial.
  7. Remove the DILUENT bottle and transfer needle.
  8. Immediately after adding the diluent, swirl vigorously for 10-15 seconds to thoroughly break up cake then swirl continuously until the powder is completely dissolved (Figure B below). Some foaming will occur, but does not affect the quality of the product.
  9. Inspect the vial visually for particulate matter and discoloration prior to pooling and administration. A few small particles may occasionally remain after reconstitution. If particles are visible, remove by passage through a sterile filter (e.g., 15 micron filter) used for administering blood products (not supplied).
  10. Reconstituted product from several vials may be pooled into an empty, sterile IV solution container by using aseptic technique. A sterile filter needle is provided for this purpose.

Described here is one acceptable method of reconstitution.  The product could also be reconstituted with other appropriate devices according to the manufacturer’s accepted procedure. 

PROLASTIN-C Reconstitution Method

Shelf Life

PROLASTIN-C should be stored at temperatures not to exceed 25°C (77°F) for the period indicated by the expiration date on its label.

Special Precautions for Storage

Freezing should be avoided as breakage of the diluent bottle might occur.

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