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RX ITEM-Bebulin 609 IU Vial by Baxalta Healthcare

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopASD Specialty Healthcare-Special OrderNDC No. 64193-0445-02 UPC/GTIN No. 3-64193-44502-5  MPN 42710 Only Physician,Pharmac Bebulin 609 IU  Vial by Baxalta Healthcare Item No. 3322995 NDC No. 64193044502 UPC No.364193-445025 364193445025  Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Image 5 of RX ITEM-Bebulin 609 IU Vial by Baxalta Healthcare

RX ITEM-Bebulin 609 IU Vial by Baxalta Healthcare

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NDC No. 64193-0445-02 UPC/GTIN No. 3-64193-44502-5 MPN 42710 Only Physician,Pharmac Bebulin 609 IU Vial by Baxalta Healthcare Item No. 3322995 NDC No. 64193044502 UPC No.364193-445025 364193445025 Other Name Bebulin Therapeutic Code 202816 Therapeutic Class Antihemophilic? Factor (Recombinant Item Class Non Controlled Rx. Case Qnty: 0 Therapeutic Code 202816 Antihemophilic? Factor (Recombinant Info Coagulation Factor Ix Human Common Grou

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BEBULIN- coagulation factor ix human
Baxalta US Inc.

DESCRIPTION

BEBULIN (Factor IX Complex), Nanofiltered and Vapor Heated is a purified, sterile, freeze-dried concentrate of the Coagulation Factor IX (Christmas Factor) as well as Factor II (Prothrombin) and Factor X (Stuart-Prower Factor) and low amounts of Factor VII. In addition, the product contains small amounts of heparin (≤ 0.15 IU heparin per IU Factor IX).

BEBULIN is standardized in terms of Factor IX content and each vial is labeled for the Factor IX content indicated in International Units (IU). One International Unit of Factor IX (according to the current International Standard for Human Blood Coagulation Factors II, IX, and X in concentrates) corresponds to the activity of Factor IX in 1 mL of fresh normal human plasma.

BEBULIN is manufactured from large plasma pools of human plasma. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of BEBULIN is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative. Validated virus removal/inactivation steps have been integrated into the manufacturing process, namely 35 nm nanofiltration1 and a vapor heat treatment process2 [10 hours at 60°C and subsequent 1 hour at 80°C under the condition of 7-8% (w/v) residual moisture]. In addition DEAE-Sephadex adsorption contributes to the virus safety profile of BEBULIN. Despite these measures, this product can still potentially transmit disease3 [see Warnings].

In vitro spiking studies have been used to validate the capability of the manufacturing process to remove and inactivate viruses. To establish virus clearance capacity of the manufacturing process, these virus clearance studies were performed in accordance with good laboratory practices under extreme conditions (e.g. at minimum incubation times and temperatures below specifications for vapor-heat treatment).

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Bebulin 700 (+ ) Vial by ASD Healthcare
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

ASD Specialty Healthcare-Special Order
AmericanPharmaWholesale.com
ASD Specialty Healthcare-Special Order

NDC No. 64193-0445-02 UPC/GTIN No. 3-64193-44502-5  MPN 42710 Only Physician,Pharmac Bebulin 609 IU  Vial by Baxalta Healthcare Item No. 3322995 NDC No. 64193044502 UPC No.364193-445025 364193445025
Bebulin 609 IU Vial by Baxalta Healthcar
NDC No. 64193-0445-02 UPC/GTIN No. 3-64193-44502-5 MPN 42710 Only Physician,Pharmac Bebulin 609 IU Vial by Baxalta Healthcare Item No. 3322995 NDC No. 64193044502 UPC No.364193-445025 364193445025

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.