Jivi Sheet Product

Listing Results Jivi Sheet Product

Frequently Asked Questions

• What is Jivi used to treat?

  Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A.

• What is Jivi made of?

  Jivi [antihemophilic factor (recombinant), PEGylated-aucl] is a sterile, nonpyrogenic, preservative-free, white to slightly yellow lyophilized powder for reconstitution with sterile Water for Injection (sWFI) as diluent for intravenous (IV) administration.

• How do I contact the FDA about Jivi antihemophilic factor?

  Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Jivi antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:

• What is the shelf life of Jivi?

  Store Jivi at +2°C to +8°C (36°F to 46°F) for up to 24 months from the date of manufacture. Within this period, Jivi may be stored for a period of up to 6 months at temperatures up to +25°C or 77°F. Record the starting date of room temperature storage clearly on the unopened product carton.

• What is Jivi used to treat?

  Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A.

• Is Jivi approved in the EU?

  The European Medicines Agency decided that Jivi’s benefits are greater than its risks and it can be authorised for use in the EU. Studies show that Jivi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products.

• What company makes Jivi?

  Developed by Bayer, it is given as an infusion into the bloodstream and also can be used on-demand in response to a bleed. How does Jivi work? Hemophilia type A is an inherited condition that results due to a mutation in the coagulation factor 8, or F8 gene.

• What is Jivi antihemophilic factor?

  Jivi antihemophilic factor (previously BAY 94-9027) is an approved prophylactic or preventive treatment for hemophilia type A patients, ages 12 or older. Developed by Bayer, it is given as an infusion into the bloodstream and also can be used on-demand in response to a bleed.