Wednesday, July 4, 2007

New 2000 IU Vial Size For Kogenate FS Treatments

IU Vial Size

Bayer HealthCare announces availability of a new 2000 IU (international unit) vial size for hemophilia A patients.

The patients are treated with Kogenate FS, Antihemophilic Factor (Recombinant), and Kogenate FS Antihemophilic

Factor (Recombinant), with BIO-SET, a Needleless Reconstitution System.

The 2000 IU vial size reduces reconstitution time by eliminating the need to mix and pool multiple vials for some patients requiring higher doses. The increased vial size also includes a new one-cut stopper and vial designed to simplify handling of reconstituted Kogenate FS.

"By reducing reconstitution time, the new 2000 IU vial size aims to make it easier for patients to be compliant with their prescribed treatment," says Terry Tenbrunsel, Vice President, Sales and Marketing, Bayer HealthCare. "The 2000 IU vial size of Kogenate FS demonstrates Bayer HealthCare's commitment to developing product enhancements that allow people living with hemophilia A to lead a better life."

To further enhance the ease and convenience of treatment for hemophilia A patients, Bayer HealthCare also introduced Grab & Go packaging for Kogenate FS with BIO-SET. The new packaging contains all the elements necessary for safe and fast rFVIII infusion in a very small box: BIO-SETreconstitution system integrated with Kogenate FS, prefilled diluent syringe, BD Safety-Lok (TM) butterfly infusion set, plus alcohol swabs, cotton pad and latex-free bandage. Grab & Go packaging will debut with the 2000 IU vial size, and soon will be available for 250, 500, and 1000 IU vial sizes of Kogenate FS with BIO-SET. The Grab & Go packaging is part of Bayer HealthCare's commitment to improve patient convenience and encourage treatment compliance.

Patients interested in trying Kogenate FS with the new 2000 IU vial size can enjoy immediate access by signing up for the Kogenate FS with BIO-SET Free Trial Program. The program gives individuals with hemophilia A in the United States* a one-time opportunity to experience treatment with Kogenate FS with BIO-SET, now featuring the 2000 IU vial size. Program enrollees receive a maximum of six free infusions of Kogenate FS with BIO-SET and the accompanying support programs and services available through Bayer HealthCare.

The Kogenate FS line of products includes the following via sizes: 250, 500, 1000 and 2000 IU. All but the 2000 IU vial sizes are provided with 2.5 mL of diluent; the 2000 IU vial size of Kogenate FS is reconstituted with 5 mL of diluent.

Kogenate FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the treatment of hemophilia A. The most frequently reported adverse events were local injection site reactions, dizziness and rash. Known intolerance or allergic reactions to constituents of the preparation is a contraindication to the use of Kogenate FS. Known hypersensitivity to mouse or hamster protein may be a contraindication to the use of Kogenate FS.

Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A, the most common type of hemophilia, is caused by deficient or defective blood coagulation proteins, known as factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately one in 5,000 males born in the United States has hemophilia.
source:www.emaxhealth.com

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