Details

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Manufacturer
OCTAPHARMA AB(SWEDEN)

Registraction Number
MAL20026054AZ

Content:
Nuwiq 500 IU Powder for Solution for Injection contains Simoctocog Alfa (recombinant human coagulation factor VIII). Each vial nominally contains 500 IU of factor VIII.
Indications:

• Hemophilia A: Used for the treatment and prevention of bleeding episodes in adults and children with Hemophilia A.
• On-demand treatment: Controls bleeding episodes as they occur.
• Perioperative management: Manages bleeding during and after surgery.
• Routine prophylaxis: Reduces the frequency of bleeding episodes by regular administration.

Instructions:
Dosage:

• On-demand treatment: The dose is determined based on body weight and the severity of the bleeding episode. Your doctor will provide specific instructions.
• Prophylaxis: Typical dose is 30-40 IU/kg every other day for adults and adolescents, and 30-50 IU/kg every other day or three times per week for children.

Administrations:

1. Reconstitution:
   • Use the provided solvent to dissolve the powder in the vial.
   • Gently swirl the vial until the powder is fully dissolved. Do not shake.
2. Injection:
   • Draw the solution into the syringe provided.
   • Administer intravenously (IV) over several minutes, as directed by your healthcare provider.
   • Rotate injection sites to prevent complications.