BERIPLEX P/N 500 POWDER FOR SOLUTION FOR INJECTION

Manufacturer
CSL Behring GmbH(GERMANY)

Registraction Number
MAL20041197ARZ

Contents:

• Active Ingredients: Human Prothrombin Complex (PCC) containing:
  • Factor II: 400 – 960 IU
  • Factor VII: 200 – 500 IU
  • Factor IX: 400 – 620 IU
  • Factor X: 440 – 1200 IU
  • Protein C: 300 – 900 IU
  • Protein S: 240 – 760 IU
• Other Ingredients: Heparin, human albumin, human antithrombin III, sodium chloride, sodium citrate, HCl or NaOH (for pH adjustment), water for injections

1. Reconstitution: Reconstitute the powder with the provided solvent (20 mL of water for injections) to achieve the required concentration.
2. Administration: Administer the reconstituted solution intravenously. The dose and rate of administration should be determined by a healthcare professional based on the patient's condition and response to treatment.
3. Precautions: Do not use if you are allergic to any of the ingredients. Monitor for adverse reactions during and after administration.
4. Storage: Store below 25°C, do not freeze. Keep the vial in its outer carton to protect from light. The reconstituted product should be used immediately, and any unused solution must be discarded appropriately.