Gamma Globulin Intravenosa Pdf File

Gamma globulin intravenosa pdf file

Immunoglobulin therapy , also known as normal human immunoglobulin NHIG , is the use of a mixture of antibodies immunoglobulins to treat a number of health conditions.

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Common side effects include pain at the site of injection, muscle pain, and allergic reactions. Human immunoglobulin therapy first occurred in the s and a formulation for injection into a vein was approved for medical use in the United States in 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 to respond to antigens as they normally should — resulting in an increased rate or increased severity of infections.

Immunoglobulin therapy is also used for a number of other conditions, including in many autoimmune disorders such as dermatomyositis in an attempt to decrease the severity of symptoms.

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Immunoglobulin therapy is also used in some treatment protocols for secondary immunodeficiencies such as human immunodeficiency virus HIV , some autoimmune disorders such as immune thrombocytopenia and Kawasaki disease , some neurological diseases multifocal motor neuropathy , stiff person syndrome , multiple sclerosis and myasthenia gravis some acute infections and some complications of organ transplantation. Different national bodies and medical associations have established varying standards for the use of immunoglobulin therapy.

The United Kingdom 's National Health Service recommends the routine use of immunoglobulin for a variety of conditions including primary immunodeficiencies and a number of other conditions, but recommends against the use of immunoglobulin in sepsis unless a specific toxin has been identified , multiple sclerosis, neonatal sepsis, and pediatric HIV. The American Academy of Allergy, Asthma, and Immunology most strongly supports the use of immunoglobulin for primary immunodeficiencies, while noting that such usage actually accounts for a minority of usage and acknowledging that immunoglobulin supplementation can be appropriately used for a number of other conditions, [10] including neonatal sepsis citing a sixfold decrease in mortality , considered in cases of HIV including pediatric HIV , considered as a second line treatment in relapsing-remitting multiple sclerosis, but recommending against its use in such conditions as chronic fatigue syndrome , PANDAS pediatric autoimmune neuropsychiatric disorders associated with streptococcal infection until further evidence to support its use is found though noting that it may be useful in PANDAS patients with an autoimmune component , cystic fibrosis, and a number of other conditions.

The National Advisory Committee on Blood and Blood Products of Canada NAC and Canadian Blood Services have also developed their own separate set of guidelines for the appropriate use of immunoglobulin therapy, which strongly support the use of immunoglobulin therapy in primary immunodeficiencies and some complications of HIV, while remaining silent on the issues of sepsis, multiple sclerosis, and chronic fatigue syndrome.

The Australian Red Cross Blood Service developed their own guidelines for the appropriate use of immunoglobulin therapy in Subcutaneous immunoglobulin access programs have been developed to facilitate hospital based programs.

Although immunoglobulin is frequently used for long periods of time and is generally considered safe, immunoglobulin therapy can have severe adverse effects, both localized and systemic. Subcutaneous administration of immunoglobulin is associated with a lower risk of both systemic and localized risk when compared to intravenous administration hyaluronidase-assisted subcutaneous administration is associated with a greater frequency of adverse effects than traditional subcutaneous administration but still a lower frequency of adverse effects when compared to intravenous administration.

Patients who are receiving immunoglobulin and experience adverse events are sometimes recommended to take acetaminophen and diphenhydramine before their infusions to reduce the rate of adverse effects.

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Additional premedication may be required in some instances especially when first getting accustomed to a new dosage , prednisone or another oral steroid. Local side effects of immunoglobulin infusions most frequently include an injection site reaction reddening of the skin around the injection site , itching, rash, and hives.

Gamma globulin intravenosa pdf file

Serious side effects of immunoglobulin infusions include chest discomfort or pain, myocardial infarction , tachycardia hyponatremia, hemolysis, hemolytic anemia, thrombosis, hepatitis, anaphylaxis, backache, aseptic meningitis, acute renal failure, hypokalemic nephropathy, pulmonary embolism, and transfusion related lung injury. In the case of less serious side effects, a patient's infusion rate can be adjusted downwards until the side effects become tolerable, while in the case of more serious side effects, emergency medical attention should be sought.

Immunoglobulin therapy also interferes with the ability of the body to produce a normal immune response to an attenuated live virus vaccine for up to a year, [16] can result in falsely elevated blood glucose levels, [16] and can interfere with many of the IgG-based assays often used to diagnose a patient with a particular infection.

After immunoglobulin therapy's discovery and description in Pediatrics in , weekly intramuscular injections of immunoglobulin IMIG were the norm until intravenous formulations IVIG began to be introduced in the s. Intramuscular injections were extremely poorly tolerated due to their extreme pain and poor efficacy — rarely could intramuscular injections alone raise plasma immunoglobulin levels enough to make a clinically meaningful difference.

Intravenous formulations began to be approved in the s, which represented a significant improvement over intramuscular objections, as they allowed for a sufficient amount of immunoglobulin to be injected to reach clinical efficacy, although they still had a fairly high rate of adverse effects though the addition of stabilizing agents reduced this further.

The first description of a subcutaneous route of administration for immunoglobulin therapy dates back to , but for many years subcutaneous administration was considered to be a secondary choice, only to be considered when peripheral venous access was no longer possible or tolerable. During the late s and early s, it became obvious that for at least a subset of patients the systemic adverse events associated with intravenous therapy were still not easily tolerable, and more doctors began to experiment with subcutaneous immunoglobulin administration, culminating in an ad hoc clinical trial in Sweden of subcutaneous injections administered to 25 adult patients most of whom had previously experienced systemic adverse effects with IMIG or IVIG , where no infusion in the ad hoc trial resulted in a severe systemic adverse reaction, and most subcutaneous injections were able to be administered in non-hospital settings, allowing for considerably more freedom for the patients involved.

In the later s, large-scale trials began in Europe to test the feasibility of subcutaneous immunoglobulin administration, although it was not until that the first subcutaneous-specific preparation of immunoglobulin was approved by a major regulatory agency Vivaglobin , which was voluntarily discontinued in Although intravenous was the preferred route for immunoglobulin therapy for many years, in the FDA approved the first preparation of immunoglobulin that was designed exclusively for subcutaneous use.

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The precise mechanism by which immunoglobulin therapy suppresses harmful inflammation is likely multifactorial. For example, it has been reported that immunoglobulin therapy can block Fas-mediated cell death. Perhaps a more popular theory is that the immunosuppressive effects of immunoglobulin therapy are mediated through IgG's Fc glycosylation. There are several other proposed mechanisms of action and the actual primary targets of immunoglobulin therapy in autoimmune disease are still being elucidated.

Some believe that immunoglobulin therapy may work via a multi-step model where the injected immunoglobulin first forms a type of immune complex in the patient.

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Other proposed mechanisms include the possibility that donor antibodies may bind directly with the abnormal host antibodies, stimulating their removal; the possibility that IgG stimulates the host's complement system , leading to enhanced removal of all antibodies, including the harmful ones; and the ability of immunoglobulin to block the antibody receptors on immune cells macrophages , leading to decreased damage by these cells, or regulation of macrophage phagocytosis.

Indeed, it is becoming more clear that immunoglobulin can bind to a number of membrane receptors on T cells , B cells , and monocytes that are pertinent to autoreactivity and induction of tolerance to self. A recent report stated that immunoglobulin application to activated T cells leads to their decreased ability to engage microglia.

Gamma globulin intravenosa pdf file

As a result of immunoglobulin treatment of T cells, the findings showed reduced levels of tumor necrosis factor-alpha and interleukin in T cell-microglia co-culture.

The results add to the understanding of how immunoglobulin may affect inflammation of the central nervous system in autoimmune inflammatory diseases. As biologicals , various trade names of immunoglobulin products are not necessarily interchangeable, and care must be exercised when changing between them.

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In Australia, blood donation is voluntary and therefore to cope with increasing demand and to reduce the shortages of locally produced immunoglobulin, several programs have been undertaken including adopting plasma for first time blood donors, better processes for donation, plasma donor centres and encouraging current blood donors to consider plasma only donation.

Experimental results from a small clinical trial in humans suggested protection against the progression of Alzheimer's Disease , but no such benefit was found in a subsequent phase III clinical trial.

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