Patients should be encouraged to consult their physician if such symptoms appear. Patients like you are maximizing their time between infusions with hyqvia, a liquid pi treatment given under the skin, once a month. Baxter healthcare corporation, westlake village, ca 962 usa. Contraindications hypersensitivity reaction to immune globulins. The recommended dose of gammagard sd for patients with chronic itp is 1 gkg. Gammagard liquid is a purified igg liquid biologic product at 10% wv. A doctor or other trained health professional will give you this medicine in a medical facility. Gammagard immune globulin is a sterilized solution made from human plasma. The distribution of the igg subclasses is similar to that of normal plasma.
Gammaked, immune globulin injection human, 10% caprylatechromatography purified. Package insert and label information page 5 of 5 16 how suppliedstorage and handling. Nov 14, 2018 baxalta us inc gammagard sd is an immune globulin intravenous human indicated for. Place thumb and index finger on the outside of the package, on top of the ends. In order to view pdf documents, you must have adobe reader software installed on your computer. Jun 21, 2019 gammagard liquid is an aqueous solution containing 10% igg 100 mgml. Package insert gammagard sd pdf 473kb supporting documents. Gammagard liquid can cause the following serious reactions. If you have questions about how to store gammagard immune globulin injection subcutaneous or iv, talk with your pharmacist. Refer to package insert for dosage and administration and compatibility with other solutions. Pull back on plunger of the syringe to fill it with air, which should equal the amount of liquid you will be taking from the vial. Mar 02, 2020 read the package insert that comes with gammagard immune globulin injection subcutaneous or iv.
Dailymed gammagard liquid immune globulin infusion human. Lcysteine hydrochloride hydrate 10 mg, sodium bisul. Cuvitru is a readytouse liquid medicine that is given under the skin subcutaneously to treat primary immunodeficiency pi in people. Thrombosis may occur with immune globulin intravenous igiv products, including octagam 5% and 10% liquid preparations.
Gammagard liquid is an immune globulin infusion human indicated as replacement therapy for primary humoral immunodeficiency pi in adult and pediatric patients two years of age or older. Gammagard liquid fda prescribing information, side effects. 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. Sep 26, 20 provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the us food and drug administration. A 62 kg patient is to receive 60g of gammagard liquid. Gammagard liquid immune globulin intravenous human. Gammagard liquid and rhuph20 in pid full text view. Please read it carefully before using this medicine. This document is provided in portable document format pdf. Treatment of primary immunodeficiency pi in adults and pediatric patients two years of age or older. Highlights of prescribing information administer concomitant. Gammagard liquid myigcopaycard program terms and conditions. Gammagard is used to treat primary immunodeficiency diseases pi in adults and children two years of age or older gammagard is also used as maintenance therapy to improve muscle strength and.
If side effects occur, the infusion should be slowed or stopped until the symptoms subside. The following summarizes important information about gammagard liquid. Components used in the packaging of this product are latexfree. Gamunexc immune globulin injection official site for. The gammagard liquid manufacturing process employs a modified cohnoncley cold. Feb 07, 2020 gammagard is also used as maintenance therapy to improve muscle strength and disability in adult patients with multifocal motor neuropathy mmn. Gammagard liquid is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin. Mmn is a rare disease that causes muscle weakness that worsens over time. Gammagard liquid and rhuph20 in pid the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The indication for treatment of acyclovir resistant hsv infections in immunocompromised patients with hiv infections is based primarily on the results of one open label comparative study. Each bag contains the following inactive ingredients. Are you an adult living with primary immunodeficiency pi.
However, since cmv usually causes latent infections and since foscarnet, like. Immune globulin intravenous human, 10% liquid privigen. Supporting documents older than three years gammagard sd. Penetrate the stopper perpendicular to its plane and within the ring. This section provides information on the proper use of a number of products that contain immune globulin. The need for additional doses can be determined by clinical response and platelet count. The product is filled into containers of type i glass, which are closed with bromobutyl rubber stoppers. Package insert gammagard liquid pdf 583kb supporting documents. Pull the solid white rod from the package and put it back in the package laying it carefully alongside the insertion tube, making sure the distal end of the rod remains sterile. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e. Gammagard liquid immune globulin infusion human 10%. Highlights of prescribing information these highlights do not include all the information needed to use gamunexc safely and effectively. Gammaked, immune globulin injection human, 10% caprylatechromatography purified initial u.
Gammagard sd is supplied in single use bottles containing the labeled amount of functionally active igg. These highlights do not include all the information needed to use gammaked safely and effectively. Immune globulin im mune glob yoo lin helps to prevent or reduce the severity of certain infections in patients who are at risk. Mar 01, 2018 package insert gammagard liquid pdf 583kb supporting documents. Insert the needle choose the correct needle length to assure that gammagard liquid is delivered into the subcutaneous space. Thrombosis may occur with immune globulin products, including privigen. Fill syringe from gammagard liquid vials remove sterile syringe from package and attach to a sterile needle.
Gammagard sd, immune globulin intravenous human, contains a broad spectrum of igg antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the us national institutes of health andor the fda. Treatment of primary immunodeficiency pi in adults and pediatric patients two. What is the most important information i need to know about cuvitru. Gammagard liquid, immune globulin infusion human, 10%. This manufacturers coupon program is not valid for prescriptions reimbursed, in whole or in part, by medicaid, medicare, medigap, va, dod, tricare, or any other federal or state healthcare programs, including state pharmaceutical assistance programs, and where prohibited by the health insurance provider or by law. Thrombosis may occur with immune globulin products, including gammagard sd. Insert needle only once, within the stopper area delineated by the raised ring for penetration. Patient information for gammagard sd 10g powder and solvent for solution for infusion including dosage instructions and possible side effects. Gammagard liquid is indicated as replacement therapy for primary humoral immunodeficiency pi in adult and pediatric patients. This medicine is collected from the pooled blood of many donors. Antepartum fetalmaternal hemorrhage suspected or proven as a result of placenta previa, amniocentesis, chorionic villus sampling, percutaneous. If you do not have adobe reader, download it from the adobe website. Listing a study does not mean it has been evaluated by the u.
Up to three separate doses may be given on alternate days if required. Csl behring immune globulin intravenous human, 10% liquid privigen us package insert july 2007 page 4. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. The patients vital signs should be observed and monitored carefully throughout the infusion. Treatment of primary immunodeficiency pi in adults and pediatric. Hypersensitivity to any component of paragard including.
Gammagard sd immune globulin intravenous human solvent. Like all medicines, gammagard sd can cause side effects, although not everybody gets them. Read the package insert that comes with gammagard immune globulin injection subcutaneous or iv. 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. Gamunexc, immune globulin injection human, 10% caprylatechromatography purified initial u. Insert needle at a 90degree angle with a darting motion into the subcutaneous tissue. Gammaked should only be administered intravenously for patients with itp and cidp. Fill out and submit the gammagard liquid start form to initiate treatment for your patients. Gammagard sd 10gm 5% low iga ivig vial immune globulin intravenous human iga less than. Gammagard liquid immune globulin intravenous human 10%. This solution is readytouse and may be administered directly to the patient without further preparation. See full prescribing information for contraindications to gammagard sd with iga.
Baxalta us inc gammagard sd is an immune globulin intravenous human indicated for. Rhod immune globulin human ultrafiltered plus 300 g. Gammagard liquid immune globulin intravenous human, 10% is a readyforuse sterile, liquid preparation of highly puri. Gammagard liquid immune globulin infusion human 10% primaryimmunodeficiencypatient. Grasp the skin and pinch at least one inch of skin between two fingers. Drugs az pill identifier supplements symptom checker diseases dictionary media. Dailymed gammagard liquid immune globulin infusion. The following side effects may generally occur after treatment. Supporting documents older than three years gammagard liquid.
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