Percentage of adjusted incat responders who completed the initial treatment period without crossing over and maintained srlqwwkurxjkzhhn. Packaging and storage gamunexc immune globulin injection. Cidp dosing and administration gamunexc immune globulin. Flush heparin lock heplock through which gamunex was administered with 5% dextrose in water d5w or 0. Recommended diluent bacteriostatic water contains benzyl alcohol as a preservative. The time to infuse is based on the maximal infusion rate.
Gamunex c may be stored for 36 months at 28c 3646f, and product may be stored at temperatures not to exceed 25c 77f for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded. Ivig intravenous immunoglobulin asceniv, bivigam, flebogamma, gammagard, gammagard sd, gammaked, gammaplex, gamunex c, octagam, panzyga, privigen. If you have questions about how to store gamunex c immune globulin injection subcutaneous or iv, talk with your pharmacist. After iv administration, three metabolites of ciprofloxacin have been identified in human urine which together account for approximately 10% of the intravenous dose. Replacement therapy in primary immunodeficiency pi diseases. Replacement therapy for primary immunodeficiency pi this includes, but is not. Gammagard liquid immune globulin intravenous human 10%. June 10, 2020 page 3 of 7 o used for reinitiation of maintenance therapy after experiencing a relapse and requiring re. Please see adjacent page for brief summary of gamunex c full prescribing information.
Hizentra immune globulin subcutaneous human igsc, 20% liquid full prescribing information warning. Highlights of prescribing information procrit epoetin alfa. Gamunex c can be administered as ivig or sub q in the treatment of pidd. If dilution is required, gamunex c may be diluted with 5% dextrose in water d5w. Gammagard liquid immune globulin intravenous human 10% description gammagard liquid immune globulin intravenous human, 10% is a readyforuse sterile, liquid. Characteristics of immunoglobulin products used to treat. The gamunex c infusion line can be flushed with 5% dextrose in water d5w or 0. Please read the full prescribing information pi for privigen immune globulin intravenous human, 10% liquid in the treatment of pi, cidp, and chronic itp. Gamunexc thrombotic events have occurred in patients. Drug therapy guidelines immune globulins intravenous.
Check product label for storage temperatures, which vary among immunoglobulin products. Gamunex c immune globulin injection human, 10% caprylatechromatography purified. Insert needle and inject all the liquid subcutaneously. Or o prolonged distal motor latency in at least 2 motor nerves. Use the table provided in the productspecific package insert to. January 1, 2019 page 3 of 6 o reduced conduction velocity in at least 2 motor nerves.
Gamunexc 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. In the presence of such factors and particularly in the presence of renal failure when high serum concentrations can be attained, central nervous. Grasp the skin between two fingers and insert the needle into t. Gamunex c is an immune globulin injection human 10% liquid that is indicated for the treatment of. The louisiana uniform prescription drug prior authorization form should be utilized to request clinical authorization for the use of immune globulin human agents. See accompanying insert in pocket for the rate of administration by patient weight. Refer to package insert for dosage and administration and compatibility with other solutions. Immune globulin asceniv, bivigam, cutaquig, cuvitru. Novaplus primacor milrinone lactate injection 200 mcgml in 5% dextrose injection description primacor, brand of milrinone lactate injection, is a member of a class of bipyridine. The recommended dose of gammaplex 10% for patients with pi is 300 to 800 mgkg 3 to 8 mlkg, administered every 3 to 4 weeks. Gamunex is indicated for the treatment of cidp to improve. 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.
Immune globulin intravenous ivig a57187 links in pdf documents are not guaranteed to work. Information for each of the products listed above has been provided directly to. Highlights of prescribing information contraindications these. Thrombosis thrombosis may occur with immune globulin products, including hizentra. Insert needle only once, within the stopper area delineated by the raised ring for penetration. Thrombosis thrombosis may occur with immune globulin products, including. Remove the second blunt needle venting needle from package. Pidd dosing and administration gamunexc immune globulin. Csl behring immune globulin intravenous human, 10% liquid. Learn about standards for the dosing and known adverse reactions. Infuse gamunex c using a separate line by itself, without mixing with other intravenous fluids or medications the subject might be receiving. Penetrate the stopper perpendicular to its plane and within the ring.
Solumedrol methylprednisolone sodium succinate for. Supporting documents older than three years gamunex c. Diagnoses addressed in this policy asthma severe, persistent, highdose steroiddependent autoimmune bullous diseases autoimmune uveitis bone. Check package insert for detailed prescribing information. Tilt vial up and ensure syringe needle tip is in the scig product. Insert syringe needle into center of rubber stopper at a 90 degree angle.
Gammagard liquid immune globulin intravenous human. Up to 6 months at any time during 36month shelf life. There have been reports of noncardiogenic pulmonary edema transfusionrelated acute lung injury trali in patients administered igiv 33. Sep 03, 2017 package insert pdf 279 kb october 2008. Dec 04, 2020 read the package insert that comes with gamunex c immune globulin injection subcutaneous or iv. Avoid simultaneous administration of gamunex and heparin through a single lumen delivery device due to gamunex, heparin incompatibilities.
Information for each of the products listed above has been provided directly to idf by the manufacturer of that product. Gamunex c significantly improved cidp in 24 weeks disability scores, incat gamunex c package insert. Human normal immunoglobulin ivig read all of this leaflet carefully before you start using this medicine because it contains important information for you. This product is exclusively distributed within the u. The proof is in gamunexc the journal of immunology. For immune globulin intravenous ivig including gamunexc, gammaked and. Insert the venting needle on a 45 angle into the side of the rubber stopper so needle tip is into an air pocket. These highlights do not include all the information needed to use gammaplex safely and effectively. Immune globulin human, 10% caprylatechromatography purified revised 920 gammaked 30364293036430. This includes, but is not limited to, congenital agamma. Gamunex c, gammagard liquid, gammaked, or xembify or o the member has been receiving intravenous immune globulin at regular intervals for at least 3 months if using hizentra and o the member has a deficiency in producing antibodies i. June 10, 2020 page 3 of 7 patients disease course is progressive or relapsing and remitting for 2 months or longer. Gamunexc immune globulin injection official site for.
The pfizer biontech covid19 vaccine has not been approved or licensed by the u. Enterococcus faecalis vancomycin susceptible isolates only staphylococcus aureus methicillinsusceptible isolates only staphylococcus epidermidis. Or o absent f wave in at least two motor nerves plus one other demyelination criterion listed here in at least 1 other nerve. Package insert gamastan sd supporting documents new recommendations to increase the dose of gamastan sd immune globulin human when used for prophylaxis for hepatitis a. Diagnoses addressed in this policy asthma severe, persistent, highdose steroiddependent autoimmune bullous diseases autoimmune uveitis bone marrow transplantation bmt chronic inflammatory demyelinating polyneuropathy. In the presence of such factors and particularly in the presence. Food and drug administration fda, but has been authorized for emergency use by fda under an emergency use authorization eua to prevent coronavirus disease 2019 covid19 for use in individuals 16 years of.
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