Search Results for "ivig"



Grifols Introduces New 40-g IVIG Vial Size for GAMUNEX-C

RTP, NC (November 6, 2014) — Grifols, a leading provider of plasma-derived therapies, announced today that the 40-g (400 mL) vial size for GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) became available on November 3. With the addition of the new 40-g vial, GAMUNEX-C now comes in 6 different vial sizes, including 1 g […]


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Enrollment for the Medicare IVIG Demonstration Project Is Still Open

Enrollment for the Medicare IVIG Demonstration Project is still open! New applications for participation in the Medicare IVIG Demonstration Project will be accepted on a rolling basis until the project reaches the statutory limit on funding and/or enrollment. For complete details and how to enroll, go to www.medicarenhic.com. The Centers for Medicare & Medicaid Services […]


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Enrollment for Medicare IVIG Demonstration Project Begins August 8, 2014

Three year demonstration project for Medicare Part B recipients will study the impact of paying for intravenous immunoglobulin (IVIG) home infusions Towson, MD, August 6, 2014 – The Immune Deficiency Foundation (IDF) is pleased to announce that the enrollment for the Medicare IVIG Demonstration Project will begin on August 08, 2014. The enrollment period will […]


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Voluntary recall of several 100 mL BIVIGAM® lots

02/20/2014 Product: BIVIGAM® Immune Globulin Intravenous (Human), 10% Liquid NDC Number (USA): 59730-6503-1 Lot Numbers: 130009, 130011,130013,130019, 130021, 130023, 130029, 130033, 130035, 130037, 130039, 130041, 130043, 130137 Size: 100ml / 10g Packaging: Vial Biotest Pharmaceuticals Corporation (BPC) has initiated a voluntary recall of the above listed lots of BIVIGAM due to the potential for a very […]


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Update: Medicare IVIG Demonstration Project Implementation Delayed

The Medicare IVIG Access Act that was signed into law in January 2013 instructed the Centers for Medicare and Medicaid Services (CMS) to create a three-year demonstration project that would reimburse for the items and services needed to do home infusions of IVIG for patients on Medicare. Prior to this demonstration project, the items and […]


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AAAAI IVIG Toolkit

Patients with primary immunodeficiency diseases have rights, especially in terms of treatment and standards of care. (Click here for IDF’s Bill of Rights for Patients with PI.) To help patients protect those rights and educate healthcare providers and/or insurance companies, the American Academy of Allergy, Asthma & Immunology (AAAAI) Primary Immunodeficiency Diseases (PID) Committee created […]


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Urgent – Drug Recall – BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid, 100 mL sterile vial

During a routine annual reserve inspection, visible particles were observed in the above lot number of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid. In the interest of patient safety, Biotest is voluntarily recalling this lot from the market. Date recall initiated:  April 2, 2013 Product:  BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid, 100 mL sterile […]


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BIVIGAM™ is the First New IVIG Product Approved with a Validated and FDA Approved Thrombin Generation Assay (TGA) Test

Biotest Pharmaceuticals Corporation (BPC), a wholly owned U.S. subsidiary of Biotest AG, recently announced the U.S. Food and Drug Administration’s (FDA) approval of BIVIGAM™, its new intravenous immune globulin, for the treatment of patients with Primary Humoral Immunodeficiency (PI). BIVIGAM is the first new intravenous immune globulin (IVIG) to be approved by the FDA with […]


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President Obama Signs Medicare IVIG Access Act in Law

IT’S DONE!!!  After the overwhelming support of both chambers of Congress, President Obama signed HR 1845, the Medicare IVIG Access Act, into law on Thursday January 10, 2013.  It has taken patients with primary immunodeficiency diseases and their families five years of working with Congress to successfully pass the bill. During that time, 361 patients, […]


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President Obama Signs into Law Medicare IVIG Access Act

IDF is proud to announce that the Medicare IVIG Access Act (HR 1845) was signed into law today, January 10, 2013, by President Obama. HR 1845 provides for a demonstration project to examine the benefits of providing coverage and payment for items and services necessary to administer intravenous immunoglobulin (IVIG) in the home for patients […]


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