Gammagard liquid immune globulin intravenous human 10%. Immune globulin intravenous human liquid preparation. Serious side effects associated with farydak include diarrhea, heart problems, and bleeding. Thrombosis may occur with immune globulin products, including privigen. This label reflects clinical trials for lupron depot in prostate cancer in which the majority of the subjects studied were at least 65 years of age. Cuvitru is a readytouse liquid medicine that is given under the skin subcutaneously to treat primary immunodeficiency pi in people. Treatment is based on a persons symptoms and level of platelets. Immunoglobulin therapy is used in a variety of conditions, many of which involve decreased or abolished antibody production capabilities, which range from a complete absence of multiple types of antibodies, to igg subclass deficiencies usually involving igg2 or igg3, to other disorders in which antibodies are within a normal quantitative range, but lacking in quality unable. Highlights of prescribing information hyperglycemia. If well tolerated, the rate of administration may gradually be increased to a maximum of 0. Oct 01, 2019 flebogamma 5% dif is a purified at least 97% igg, unmodified, human igg. Gammagard liquid immune globulin intravenous human. Csl behring immune globulin intravenous human, carimune.
Gamunexc immune globulin injection official site for. Flebogamma 5% dif is a liquid preparation containing 5% igg 50 mg per ml. Aliqopa copanlisib for injection, for intravenous use. Jun 21, 2019 flebogamma 10% dif is a human immune globulin intravenous igiv that is indicated for the treatment of primary immune deficiency pi including the humoral immune defect in common variable immunodeficiency, xlinked agammaglobulinemia, severe combined immunodeficiency, and wiskottaldrich syndrome. Flebogamma 5% dif is also available, for the treatment of pi in adults and pediatric patients 2 years of age and older.
Breo ellipta fluticasone furoate and vilanterol inhalation. Sign up to receive more information about flebogamma dif. Find patient medical information for flebogamma intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Fda prescribing information for flebogamma 10% dif. The product should be brought to room or body temperature before use. The distribution of the four igg subclasses is approximately 66. Thrombosis, renal dysfunction, or acute renal failure 18thrombosis may occur with immune globulin products, including carimune nf. Gammaked is an immune globulin ig injection approved to treat chronic inflammatory demyelinating polyneuropathy cidp in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse, primary humoral immunodeficiency pi in patients 2 years of age and older, and idiopathic thrombocytopenic purpura itp in adults and children to raise platelet.
The product is manufactured by the cohnoncley cold ethanol. Flebogamma 10% dif immune globulin intravenous human dose. These highlights do not include all the information needed to use flebogamma 10% dif safely and effectively. Highlights of prescribing information hyperglycemia and. Immune globulin intravenous human liquid preparation octagam. Dosage and directions for administration, see package insert. Flebogamma dif fda prescribing information, side effects. Flebogamma 5% dif contains trace amounts of iga typically less than 50. If you do not have adobe reader, download it from the adobe website. Gammaplex 10% immune globulin intravenous human, 10% liquid. Csl behring immune globulin intravenous human, carimune nf. Information for the user venofer 20 mg iron ml solution for injection or concentrate for solution for infusion iron sucrose this medicine is subject to additional monitoring. Immune globulin intravenous human flebogamma 5% rx only description.
Flebogamma 5% dif should be infused intravenously at an initial rate of 0. Csl behring immune globulin intravenous human, carimune nf, nanofiltered lyophilized preparation only warning. Mar 02, 2018 persons with disabilities having problems accessing any of these files may call cbers consumer affairs branch 3018271800 for assistance. Igg and iggcomplexes are broken down in cells of the reticuloendothelial system. Farydak can cause serious side effects in some people. Flebogamma dif is convenient for you and your patients.
Principal display panel vial label ndc 6195300047 immune globulin intravenous human flebogamma 5% dif 2. Protect from freezing store below 77 degrees f privigen. Indications, dose, contraindications, sideeffects, interactions, cautions, warnings and other safety information for flebogamma dif. On this page about flebogamma 5% dif you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme pbs as well as other useful information. Package insert flebogamma dif 5% pdf 210kb package insert flebogamma dif 10% pdf. Gammagard liquid immune globulin intravenous human 10% description gammagard liquid immune globulin intravenous human, 10% is a readyforuse sterile, liquid preparation of highly puri. Flebogamma 10% dif flebogamma dif 100 mgml highly purified, human immunoglobulin 10% solution ready for intravenous use. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 4 version 10. These highlights do not include all the information needed to use gammaked safely and effectively. Immune globulin intravenous human flebogamma 5% 10 g.
See the information for patients insert for detailed instructions on the handling and injection of kineret. Your doctor will do regular tests before and during treatment to check the levels of fluid and electrolytes in your blood, platelet counts, and an electrocardiogram ecg. This halflife may vary from patient to patient, in particular in primary immunodeficiency. This document is provided in portable document format pdf. Nov 19, 2019 principal display panel vial label ndc 6195300047 immune globulin intravenous human flebogamma 5% dif 2. Flebogamma 10% dif immune globulin intravenous human new. Highlights of prescribing information these highlights do not. Gammaplex 10% immune globulin intravenous human, 10% liquid is indicated for replacement therapy in primary humoral immunodeficiency pi in adults and pediatric patients 2 years of age and older. See full prescribing information for flebogamma 10% dif flebogamma 10% dif immune globulin intravenous human, solution for intravenous administration initial u.
Flebogamma dif contains a broad spectrum of antibodies. Immune globulin intravenous human, flebogamma 5% igiv is a sterile, clear or slightly opalescent and colorless to pale yellow, liquid, pasteurized preparation of highly purified immunoglobulin igg. Gamunex c immune globulin injection human, 10% caprylatechromatography purified is indicated for the treatment of primary humoral immunodeficiency disease pidd in patients 2 years of age and older, idiopathic thrombocytopenic purpura itp in adults and children, and chronic inflammatory demyelinating polyneuropathy cidp in adults. Flebogamma dif 50 mg ml has a halflife of about 30 32 days. Package insert flebogamma dif 5% pdf 210kb package insert flebogamma dif 10% pdf 194kb. What is the most important information i need to know about cuvitru. Nov 19, 2019 these highlights do not include all the information needed to use flebogamma 10% dif safely and effectively. Flebogamma dif primary immunodeficiency and autoimmune. Dailymed flebogamma dif immune globulin intravenous human. Highlights of prescribing information these highlights do. Flebogamma dif 50mgml summary of product characteristics. Varying concentrations and vial sizes of flebogamma dif make it easy to personalize dosing. Flebogamma 10% dif for intravenous use only rx only brief summary consult package insert for full prescribing information indications and usage flebogamma 10% dif is a human immune globulin intravenous igiv that is indicated for the treatment of primary. Flebogamma 10% dif immune globulin intravenous human.
Gammaked, immune globulin injection human, 10% caprylatechromatography purified initial u. The solution should be clear or slightly opalescent. See full prescribing information for flebogamma 10% dif flebogamma 10% dif immune globulin intravenous human, solution for. Flebogamma dif imm glob g iggsorbiga 050 this medication is used to strengthen the bodys natural defense system immune system to lower the risk of infection in persons with a weakened immune system. You can help by reporting any side effects you may get. Aug 22, 2019 package label principal display panel 200 ml vial. Patient risk factors and certain clinical conditions should be considered when selecting which concentration of ivig to use. Replacement therapy in primary inherited humoral immune deficiency disorders. Solution for intravenous injection containing 10% igg 100. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. Flebogamma 5% dif is a purified at least 97% igg, unmodified, human igg. Flebogamma immune globulin human intravenous solution. Solution for intravenous injection containing 10% igg 100 mg.
See the lupron depot ped package insert for the use of leuprolide acetate in children with central precocious puberty. Discard product if it contains particulate matter, is cloudy, or discolored discard unused portion. Dailymed flebogamma dif immune globulin human injection. Inflectra infliximab dyyb this product information is intended only for residents of the united states. Visually inspect the solution for particulate matter and discoloration before administration. Do not use kineret beyond the expiration date shown on the carton. Dailymed flebogamma dif immune globulin intravenous. Persons with disabilities having problems accessing any of these files may call cbers consumer affairs branch 3018271800 for assistance. Discontinue aliqopa if lifethreatening aliqoparelated toxicity occurs. The bleeding results from unusually low levels of platelets.
This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, xlinked agammaglobulinemia, congenital. Itp is a disorder that can lead to easy or excessive bruising and bleeding. Flebogamma 5% dual inactivation and filtration dif, a new 5% liquid intravenous immunoglobulin with a stability of 2 years when stored at temperatures between 2 and 30c, has been developed. Flebogamma fda prescribing information, side effects and uses. Immune globulin intravenous human, 10% liquid privigen. If side effects occur, the infusion should be slowed or stopped until the symptoms subside.
Flebogamma dif imm glob g iggsorbiga 050 this medication is used to strengthen the bodys natural defense system immune system to lower the risk of infection in persons with. This will allow quick identification of new safety information. Buy flebogamma dif imm glob g igg sorb iga 0 50 online. See package insert for detailed storage information polygam sd. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Immune globulin intravenous human solvent detergent treated description gammagard sd, immune globulin intravenous human igiv is a solventdetergent treated, sterile, freezedried preparation of highly purified immunoglobulin g igg derived from large pools of human plasma. In order to view pdf documents, you must have adobe reader software installed on your computer. Do not freeze protect from light store at room temperature up to 77 degrees f. Hizentra, immune globulin subcutaneous human package insert. Thrombosis may occur with immune globulin intravenous igiv products, including octagam 5% and 10% liquid preparations. Ivig intravenous immunoglobulin asceniv, bivigam, flebogamma, gammagard, gammagard sd, gammaked, gammaplex, gamunexc, octagam, panzyga, privigen.
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