Each ml contains the equivalent of 50 mg of elemental iron as an iron dextran complex, approximately 0. Csl behring immune globulin intravenous human, 10%. Are you an adult living with primary immunodeficiency pi. See package insert for detailed storage information polygam sd. Gammagard liquid package insert, westlake village, ca. Visually inspect the solution for particulate matter and discoloration before administration. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents esas to target a. Dailymed carimune nanofiltered human immunoglobulin g. Cuvitru is a readytouse liquid medicine that is given under the skin subcutaneously to treat primary immunodeficiency pi in people. Gamunexc immune globulin injection official site for. Csl behring full prescribing information privigen, immune globulin intravenous human, 10% liquid warning. Refer to each products package insert for special considerations for each product. Highlights of prescribing information varivax safely and. This will direct the stream of diluent against the.
Cerezyme is the only ert enzyme replacement therapy that has shown longterm efficacy and safety in multiple studies over 10 years and has been prescribed for over 20 years learn more about cerezyme and talk to your doctor to see if cerezyme is right for you. Aredia, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Tell your caregiver if you feel dizzy, nauseated, lightheaded, sweaty, or have a headache, pounding in your neck or ears, fever, chills, chest tightness, or warmth or redness in. Carimune nf fda prescribing information, side effects. Insert the exposed needle into the diluent vial to the hub fig. Gammaked, immune globulin injection human, 10% caprylatechromatography purified initial u. This document is provided in portable document format pdf. Carimune nf is available as a white lyophilized powder in 3, 6 and 12 g size vials.
Gammagard liquid immune globulin intravenous human 10%. Gamunexc is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. Ivig intravenous immunoglobulin asceniv, bivigam, flebogamma, gammagard, gammagard sd, gammaked, gammaplex, gamunexc, octagam, panzyga, privigen. Carimune nf is prepared from plasma consists of fractionation and purification steps that comprise filtrations in the presence of filter aids. In order to view pdf documents, you must have adobe reader software installed on your computer. Each product presentation includes a package insert. This binding is independent of concentration and is not affected by the presence of phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, heparin, or aspirin. Please see full important safety information for privigen and carimune nf on. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Updated dosing instructions for immune globulin human. The manufacturing process by which carimune nf is prepared from plasma consists of fractionation and purification steps that comprise filtrations in the presence of filter aids. Thrombosis, renal dysfunction and acute renal failure measles exposurethrombosis may occur with immune globulin products, including. The only diluents which may be used to reconstitute the product are sterile 0.
Thrombosis may occur with immune globulin products, including privigen. There is no maximum dosage of gamastan sd for hepatitis a prophylaxis 1. Ensure adequate hydration in patients before administration. Do not use kineret beyond the expiration date shown on the carton. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 4 version 10. Immune globulin acute intravenous human carimune nf.
Get emergency medical help if you have signs of an allergic reaction. Feb 10, 2020 carimune nf, nanofiltered, immune globulin intravenous human, is a sterile, highly purified polyvalent antibody product containing in concentrated form all the igg antibodies which regularly occur in the donor population. In children with chronic itp, carimune therapy resulted in a mean rise in. Csl behring immune globulin intravenous human, carimune. Each product presentation includes a package insert and the following components. Cough increased, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis. Discard product if it contains particulate matter, is cloudy, or discolored discard unused portion. If side effects occur, the infusion should be slowed or stopped until the symptoms subside. Csl behring immune globulin intravenous human, 10% liquid. Navelbine vinorelbine tartrate injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Gammagard liquid immune globulin infusion human 10%. Find patient medical information for carimune nf nanofiltered intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Do not freeze protect from light store at room temperature up to 77 degrees f. Bivigam, carimune, flebogamma, gammagard sd, gammaplex, octagam, panzyga, privigen.
To reconstitute carimune nf from the individual vial package, or when using other diluents or higher concentrations, table 4 indicates the volume of sterile diluent required. See the information for patients insert for detailed instructions on the handling and injection of kineret. What is the most important information i need to know about cuvitru. Know your ivig options for primary immunodeficiency privigen.
Each product presentation includes a package insert and the following. Carimune nf fda prescribing information, side effects and uses. Thrombosis may occur with immune globulin intravenous igiv products, including octagam 5% and 10% liquid preparations. Carimune nf immune globulin intravenous human dose. If you do not have adobe reader, download it from the adobe website. Carimune nf contains a broad spectrum of antibody specificities against bacterial, viral, parasitic, and mycoplasma antigens, that are capable of both opsonization and neutralization of microbes and toxins.
Csl behring immune globulin intravenous human, carimune nf. Invert the diluent vial and insert the attached needle into the thrombate iii vial at a 45 angle fig. Gammagard liquid immune globulin intravenous human 10% description gammagard liquid immune globulin intravenous human, 10% is a readyforuse sterile, liquid preparation of highly puri. Cerezyme is the only ert enzyme replacement therapy that. Immune globulin intravenous human, 10% liquid privigen. 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. Cerezyme imiglucerase for injection is indicated for. It is contraindicated in igadeficient patients with antibodies against iga and history of hypersensitivity.
Carimune nf is indicated for the maintenance treatment of patients with primary immunodeficiencies pi, such as common variable immunodeficiency, xlinked. In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents esas to target a hemoglobin levelof greater than 11 gdl5. Carimune nf is indicated for the maintenance treatment of patients with primary immunodeficiencies pid, e. The recommended dosing schedule is 3 mgkg administered intravenously over a 90minute period every 3 weeks for a total of 4 doses1 assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including lfts and thyroid function tests at baseline and before each dose. See the prescribing information for each agent for more information about aes.
Patients like you are maximizing their time between infusions with hyqvia, a liquid pi treatment given under the skin, once a month. Contraindications warnings fluorouracil warnings see boxed. Gamastan sd is the only ig product approved by the food and drug administration for. Part of the fractionation may be performed by another us. Immune globulin intravenous human liquid preparation. See full prescribing information for complete boxed warning. Immune globulin intravenous human liquid preparation octagam.
Thrombosis, renal dysfunction and acute renal failure measles exposurethrombosis may occur with immune globulin products, including privigen. Highlights of prescribing information these highlights do not. These highlights do not include all the information needed to use gammaked safely and effectively. Carimune nf is made suitable for intravenous use by treatment at acid ph in the presence of trace amounts of pepsin 2, 3. Gammagard liquid is a readytouse liquid medicine that is given in a vein intravenously or under the skin subcutaneously to treat primary immunodeficiency pi in people 2 years and older and given in a vein to treat multifocal motor neuropathy mmn in adults. Diagnoses addressed in this policy asthma severe, persistent, high. Neupogen is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresissee clinical studies 14. Please see full important safety information for privigen and carimune nf on following pages and full prescribing information, including boxed warning. Find patient medical information for carimune intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Observing aseptic technique, this volume should be drawn into a sterile hypodermic syringe and needle. Protect from freezing store below 77 degrees f privigen.
Bivigam, carimune nf, flebogamma dif, gammagard liquid, gammagard sd. Immune globulin intravenous human carimune nf, nanofiltered. Pamidronate disodium is designated chemically as phosphonic acid 3amino1hydroxypropylidene bis, disodium salt, pentahydrate, apd, and its structural formula is insert structure. 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. Infed iron dextran injection usp is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use.
In addition to its use in pidd, exogenous immune globulin product has been fda. The effect of ig preparations on the response to certain livevirus vaccines is unknown, but antibodies in gamastan sd might interfere with livevirus vaccines such as measles, mumps, and rubella mmr. Gammagard liquid immune globulin intravenous human. Carefully grip the sheath of the other end of the transfer needle and twist to remove it. This immunoglobulin preparation is produced by cold alcohol fractionation from the plasma of us donors. The duration of neupogen therapy needed to attenuate chemotherapyinduced neutropenia may be. Having a better understanding of your condition is an. Issued 102000 4 novantrone package insert 016609 mitoxantrone is 78% bound to plasma proteins in the observed concentration range of 26455 ngml. Immune globulin intravenous human igiv, carimune nf, nanofiltered, is a sterile, highly purified polyvalent antibody product containing in concentrated form all the igg antibodies which regularly occur in the donor population 1. Dosing and administration for cinvanti, a syntheticsurfactantfree aprepitant formulation1 use cinvanti prior to hec or mec in combination with other antiemetics to prevent nausea and vomiting. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Carimune nf, nanofiltered, immune globulin intravenous human, is a sterile, highly purified polyvalent antibody product containing in concentrated form all the igg antibodies which regularly occur in the donor population. Intrathecal administration of other vinca alkaloids has resulted in death.
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