Mô tả
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
Indication:
BERIPLEX P/N 500 is used for the treatment of bleeding episodes in patients with hemophilia B (congenital Factor IX deficiency) and for the prevention of bleeding in surgical interventions or other situations where bleeding risk is increased.
Instructions:
- Reconstitution: Reconstitute the powder with the provided solvent (20 mL of water for injections) to achieve the required concentration.
- 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.
- Precautions: Do not use if you are allergic to any of the ingredients. Monitor for adverse reactions during and after administration.
- 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.
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