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Bioclate Drug Description
BIOCLATE™
ANTIHEMOPHILIC FACTOR (RECOMBINANT)
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), BioclateTM is a glyco-protein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix prepared by immobilization of a monoclonal antibody directed to factor VIII is utilized to selectively isolate the rAHF in the medium. The rAHF produced has the same biological effects as Antihemophilic Factor (Human) [AHF(Human)] and structurally has a similar combination of heterogeneous heavy and light chains as found in AHF (Human).
BioclateTM is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant AHF for intravenous injection and is available in single-dose bottles which contain nominally 250, 500 and 1000 International Units per bottle. When reconstituted with the appropriate volume of diluent, it contains the following stabilizers in maximum amounts: 12.5 mg/mL Albumin (Human), 1.5 mg/mL polyethylene glycol (3350),180 mEq/L sodium, 55 mM histidine, 1.5 pg/AHF International Unit (IU) polysorbate-80 and 0.20 mg/mL calcium. Von Willebrand Factor (vWF) is coexpressed with the Antihemophilic Factor (Recombinant) and helps to stabilize it. The final product contains not more than 2 ng vWF/IU rAHF which will not have any clinically relevant effect in patients with von Willebrands disease. The product contains no preservative.
Manufacturing of BioclateTM is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. Genetics Institute produces Antihemophilic Factor Concentrate (Recombinant) (For Further Manufacturing Use) which is then formulated and packaged at Baxter Healthcare Corporation, Hyland Division.
Each bottle of BioclateTM is labeled with the AHF activity expressed in IU per bottle. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.Last reviewed on RxList: 12/8/2004




Bioclate Drug Description
BIOCLATE™
ANTIHEMOPHILIC FACTOR (RECOMBINANT)
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), BioclateTM is a glyco-protein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix prepared by immobilization of a monoclonal antibody directed to factor VIII is utilized to selectively isolate the rAHF in the medium. The rAHF produced has the same biological effects as Antihemophilic Factor (Human) [AHF(Human)] and structurally has a similar combination of heterogeneous heavy and light chains as found in AHF (Human).
BioclateTM is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant AHF for intravenous injection and is available in single-dose bottles which contain nominally 250, 500 and 1000 International Units per bottle. When reconstituted with the appropriate volume of diluent, it contains the following stabilizers in maximum amounts: 12.5 mg/mL Albumin (Human), 1.5 mg/mL polyethylene glycol (3350),180 mEq/L sodium, 55 mM histidine, 1.5 pg/AHF International Unit (IU) polysorbate-80 and 0.20 mg/mL calcium. Von Willebrand Factor (vWF) is coexpressed with the Antihemophilic Factor (Recombinant) and helps to stabilize it. The final product contains not more than 2 ng vWF/IU rAHF which will not have any clinically relevant effect in patients with von Willebrands disease. The product contains no preservative.
Manufacturing of BioclateTM is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. Genetics Institute produces Antihemophilic Factor Concentrate (Recombinant) (For Further Manufacturing Use) which is then formulated and packaged at Baxter Healthcare Corporation, Hyland Division.
Each bottle of BioclateTM is labeled with the AHF activity expressed in IU per bottle. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.Last reviewed on RxList: 12/8/2004




Bioclate Drug Description
BIOCLATE™
ANTIHEMOPHILIC FACTOR (RECOMBINANT)
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), BioclateTM is a glyco-protein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix prepared by immobilization of a monoclonal antibody directed to factor VIII is utilized to selectively isolate the rAHF in the medium. The rAHF produced has the same biological effects as Antihemophilic Factor (Human) [AHF(Human)] and structurally has a similar combination of heterogeneous heavy and light chains as found in AHF (Human).
BioclateTM is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant AHF for intravenous injection and is available in single-dose bottles which contain nominally 250, 500 and 1000 International Units per bottle. When reconstituted with the appropriate volume of diluent, it contains the following stabilizers in maximum amounts: 12.5 mg/mL Albumin (Human), 1.5 mg/mL polyethylene glycol (3350),180 mEq/L sodium, 55 mM histidine, 1.5 pg/AHF International Unit (IU) polysorbate-80 and 0.20 mg/mL calcium. Von Willebrand Factor (vWF) is coexpressed with the Antihemophilic Factor (Recombinant) and helps to stabilize it. The final product contains not more than 2 ng vWF/IU rAHF which will not have any clinically relevant effect in patients with von Willebrands disease. The product contains no preservative.
Manufacturing of BioclateTM is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. Genetics Institute produces Antihemophilic Factor Concentrate (Recombinant) (For Further Manufacturing Use) which is then formulated and packaged at Baxter Healthcare Corporation, Hyland Division.
Each bottle of BioclateTM is labeled with the AHF activity expressed in IU per bottle. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.Last reviewed on RxList: 12/8/2004




Bioclate Drug Description
BIOCLATE™
ANTIHEMOPHILIC FACTOR (RECOMBINANT)
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), BioclateTM is a glyco-protein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix prepared by immobilization of a monoclonal antibody directed to factor VIII is utilized to selectively isolate the rAHF in the medium. The rAHF produced has the same biological effects as Antihemophilic Factor (Human) [AHF(Human)] and structurally has a similar combination of heterogeneous heavy and light chains as found in AHF (Human).
BioclateTM is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant AHF for intravenous injection and is available in single-dose bottles which contain nominally 250, 500 and 1000 International Units per bottle. When reconstituted with the appropriate volume of diluent, it contains the following stabilizers in maximum amounts: 12.5 mg/mL Albumin (Human), 1.5 mg/mL polyethylene glycol (3350),180 mEq/L sodium, 55 mM histidine, 1.5 pg/AHF International Unit (IU) polysorbate-80 and 0.20 mg/mL calcium. Von Willebrand Factor (vWF) is coexpressed with the Antihemophilic Factor (Recombinant) and helps to stabilize it. The final product contains not more than 2 ng vWF/IU rAHF which will not have any clinically relevant effect in patients with von Willebrands disease. The product contains no preservative.
Manufacturing of BioclateTM is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. Genetics Institute produces Antihemophilic Factor Concentrate (Recombinant) (For Further Manufacturing Use) which is then formulated and packaged at Baxter Healthcare Corporation, Hyland Division.
Each bottle of BioclateTM is labeled with the AHF activity expressed in IU per bottle. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.Last reviewed on RxList: 12/8/2004




Bioclate Drug Description
BIOCLATE™
ANTIHEMOPHILIC FACTOR (RECOMBINANT)
DRUG DESCRIPTION
Antihemophilic Factor (Recombinant), BioclateTM is a glyco-protein synthesized by a genetically engineered Chinese Hamster Ovary (CHO) cell line. In culture the CHO cell line secretes recombinant antihemophilic factor (rAHF) into the cell culture medium. The rAHF is purified from the culture medium utilizing a series of chromatography columns. A key step in the purification process is an immunoaffinity chromatography methodology in which a purification matrix prepared by immobilization of a monoclonal antibody directed to factor VIII is utilized to selectively isolate the rAHF in the medium. The rAHF produced has the same biological effects as Antihemophilic Factor (Human) [AHF(Human)] and structurally has a similar combination of heterogeneous heavy and light chains as found in AHF (Human).
BioclateTM is formulated as a sterile, nonpyrogenic, off-white to faint yellow, lyophilized powder preparation of concentrated recombinant AHF for intravenous injection and is available in single-dose bottles which contain nominally 250, 500 and 1000 International Units per bottle. When reconstituted with the appropriate volume of diluent, it contains the following stabilizers in maximum amounts: 12.5 mg/mL Albumin (Human), 1.5 mg/mL polyethylene glycol (3350),180 mEq/L sodium, 55 mM histidine, 1.5 pg/AHF International Unit (IU) polysorbate-80 and 0.20 mg/mL calcium. Von Willebrand Factor (vWF) is coexpressed with the Antihemophilic Factor (Recombinant) and helps to stabilize it. The final product contains not more than 2 ng vWF/IU rAHF which will not have any clinically relevant effect in patients with von Willebrands disease. The product contains no preservative.
Manufacturing of BioclateTM is shared by Baxter Healthcare Corporation, Hyland Division and Genetics Institute, Inc. Genetics Institute produces Antihemophilic Factor Concentrate (Recombinant) (For Further Manufacturing Use) which is then formulated and packaged at Baxter Healthcare Corporation, Hyland Division.
Each bottle of BioclateTM is labeled with the AHF activity expressed in IU per bottle. Biological potency is determined by an in vitro assay which is referenced to the World Health Organization (WHO) International Standard for Factor VIII:C Concentrate.Last reviewed on RxList: 12/8/2004





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Learn about the prescription medication Bioclate (Antihemophilic Factor), drug uses, dosage, side effects, drug interactions, warnings, and patient labeling. Bioclate (Antihemophilic Factor) Drug Information: Uses, Side ...


What is Bioclate (Antihemophilic Factor)? Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is ... Bioclate - Drugs & Treatments - Revolution Health


Bioclate Information, Learn About Bioclate, Bioclate Forums, How to Take Bioclate, Bioclate Side Effects, Bioclate Interactions, Discussion Threads, Medication Warnings ... Bioclate - The People's Medicine Community


Review of Bioclate - drugs for hemophilia and blood clots. Bioclate - drug review, buy Bioclate or equivalent


Find patient medical information for Bioclate IV on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Bioclate IV : Uses, Side Effects, Interactions, Pictures, Warnings ...


Read doctor-produced health and medical information written for you to make informed decisions about your health concerns. ANTIHEMOPHILIC FACTOR, RECOMBINANT - INJECTION (Bioclate, Helixate ...


Important Note: The Following Information Is Intended To Supplement, Not Substitute For, The Expertise And Judgment Of Your Physician, Pharmacist Or Other Healthcare Professional. BIOCLATE Patient Assistance Program


Antihemophilic factor is a protein in the blood necessary in forming clots to stop bleeding Bioclate Used To Temporarily Prevent Or Control Bleeding Episodes ...


Bioclate Read Experiences, Ask Questions and Exchange Thoughts on Bioclate - 100% Free. 100% Helpful. Bioclate - Ask Your Questions on Bioclate - Healthsofa.com


Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A. This medication ... Bioclate - User ratings & reviews - Revolution Health





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