DRIED FACTOR VIII FRACTION I.P.

What is Dried Factor VIII Fraction I.P.?

Dried Factor VIII Fraction I.P. is a lyophilized (freeze-dried) blood coagulation factor derived from human plasma. It contains Factor VIII, an essential protein involved in blood clotting. This product is used for replacement therapy in patients who are deficient in Factor VIII, especially those with Hemophilia A.

It is supplied as a sterile powder for intravenous (IV) administration after reconstitution with a suitable diluent.

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What is the Use of Dried Factor VIII Fraction I.P.?

Dried Factor VIII Fraction I.P. is primarily used in the treatment and prevention of bleeding episodes in individuals with:

• Hemophilia A (Factor VIII deficiency)

• Congenital or acquired Factor VIII deficiency

• Bleeding during or after surgery in patients with Hemophilia A

• Prophylaxis to prevent or reduce the frequency of bleeding episodes

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Benefits of Dried Factor VIII Fraction I.P.

• Effective Bleeding Control: Quickly restores Factor VIII levels to stop or prevent bleeding.

• Prophylactic Use: Can be administered regularly to prevent spontaneous bleeding in severe Hemophilia A.

• Surgical Safety: Provides necessary clotting support during surgical procedures.

• Improved Quality of Life: Reduces frequency and severity of bleeding, allowing for a more active lifestyle.

• Trusted Plasma-Derived Product: Subjected to viral inactivation steps and strict quality control to ensure safety.

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Side Effects of Dried Factor VIII Fraction I.P.

While generally safe and well-tolerated, some patients may experience side effects:

Common Side Effects:

• Mild fever

• Chills

• Injection site reactions (pain, redness, swelling)

Serious but Rare Side Effects:

• Allergic reactions (rash, itching, swelling, difficulty breathing)

• Development of inhibitors (antibodies) against Factor VIII, which can reduce treatment effectiveness

• Thromboembolic events (in very rare cases)

Always report any unusual symptoms or signs of allergic reaction to a healthcare provider immediately.

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Precautions and Warnings

• Should only be administered under the supervision of a trained healthcare professional.

• Patients should be monitored for the development of inhibitors through regular blood tests.

• Not to be used in individuals with known hypersensitivity to human plasma proteins.

• Use with caution in patients with a history of cardiovascular disease due to potential risk of thrombosis.

1. What is Dried Factor VIII Fraction I.P.?
   It is a sterile, freeze-dried preparation of human coagulation Factor VIII used to treat and prevent bleeding episodes in patients with Hemophilia A.

2. Who needs Dried Factor VIII Fraction I.P.?
   It is primarily used by individuals with Hemophilia A, a genetic disorder where the body lacks or has low levels of Factor VIII, leading to difficulty in blood clotting.

3. How is Dried Factor VIII Fraction I.P. administered?
   It is given by intravenous (IV) injection after being reconstituted with a sterile diluent.

4. How often should it be administered?
   The dosing and frequency depend on the severity of bleeding, type of surgery, or prophylactic needs, and must be determined by a physician.

5. Can it be used for all types of Hemophilia?
   No. It is specifically for Hemophilia A (Factor VIII deficiency). It is not effective in Hemophilia B (Factor IX deficiency).

6. What are the benefits of using Dried Factor VIII Fraction I.P.?
   It helps in rapid control of bleeding, prevention of bleeding episodes, and allows patients to lead more active lives.

7. What are the side effects of Dried Factor VIII Fraction I.P.?
   Side effects may include mild fever, allergic reactions, injection site discomfort, and rarely, the development of inhibitors (antibodies).

8. What are inhibitors in Hemophilia treatment?
   Inhibitors are antibodies that neutralize the activity of Factor VIII, making the treatment less effective or ineffective.

9. Can allergic reactions occur?
   Yes, although rare, allergic or anaphylactic reactions may occur. Symptoms include rash, itching, swelling, or breathing difficulty.

10. Is it safe for children?
    Yes. Dried Factor VIII Fraction I.P. is commonly used in pediatric patients with Hemophilia A under medical supervision.

11. Is the product derived from human blood?
    Yes. It is plasma-derived, meaning it is extracted from human blood and undergoes strict screening and viral inactivation processes.

12. Does it prevent bleeding during surgery?
    Yes, it is used before, during, and after surgery in Hemophilia A patients to ensure adequate clotting and prevent excessive bleeding.

13. Can it be self-administered at home?
    With proper training and under a doctor’s guidance, some patients may self-administer it at home, especially for prophylactic use.

14. How should it be stored?
    Store in a refrigerator (2°C–8°C). Do not freeze. Follow storage instructions provided by the manufacturer and reconstitute only before use.

15. Can Dried Factor VIII Fraction I.P. be used during infections or illness?
    Yes, but consult your doctor. The dose may be adjusted depending on the condition and severity of bleeding.