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ATGAM PACKAGE INSERT PDF

ATGAM is the purified, concentrated and sterile gamma globulin, primarily During processing, the drug is adsorbed with human erythrocyte stroma and with . Globulin [Equine] Sterile Solution. Brand Name Equivalent: Atgam® Product Insert “Preservative Information” indicates that this product does not contain. Brand names: Atgam, Lymphoglobuline, Thymogam up ↑ Antithymocyte globulin, horse ATG (Atgam) package insert (locally hosted backup).

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Effects of antithymocyte globulin on cytomegalovirus infection in renal transplant recipients. Cardiac failure congestive Vascular disorders: Study 2 was a randomized controlled trial conducted at five different transplant centers.

ATGAM is used with concomitant immunosuppressants. Also, skin testing done as described above will not predict for later development of serum sickness. The predictive value of this test has not been proven clinically. A randomized double-blind, placebo prospective, controlled study was conducted to compare the safety and efficacy of ATGAM and androgen oxymetholone; OXY immunosuppressive therapy with the combination of ATGAM, androgen OXY and an infusion of HLA mismatched bone marrow in patients with severe aplastic anemia who were not candidates for bone marrow transplantation.

Adverse reactions in both groups were comparable and included rash, chills, gastrointestinal disturbances, and joint pain during ATGAM infusion, as well as symptoms of serum sickness in all patients. Antithymocyte globulins can cause anaphylaxis when injected intravenously.

A systemic reaction such as a generalized rash, tachycardia, dyspnea, hypotension, or anaphylaxis precludes any additional administration of ATGAM. Infusion site erythema, Infusion site swelling, Pain. ATGAM is a transparent to slightly opalescent aqueous protein solution.

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If the subject does not show a wheal ten minutes after pricking, proceed to intradermal testing with 0. There was no difference in the patient survival rate between the two treatment groups.

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Serum insedt occurred in all patients within 6 to 18 days of ATGAM initiation and was well-controlled with standard therapy. Abdominal pain, Gastrointestinal atgxm, Gastrointestinal perforation, Oral pain Skin and subcutaneous tissue disorders: Start dosing at the low end of the dosage range. General disorders and administration site conditions: The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.

Transplantation ; 28 4: Gently rotate or swirl the diluted solution to effect thorough mixing.

Therefore, this toxicity is not considered relevant to human fetal development. Pediatric Nephrol ; 5: Confusional state, Disorientation Nervous system disorders: Previously masked reactions to ATGAM may appear when the dose of corticosteroids and other immunosuppressants is being reduced.

However, because ATGAM afgam a gamma globulin product, it can be transparent to slightly opalescent, colorless to faintly pink or brown, and may develop inser slight granular or flaky deposit during storage. Apnea, Cough, Epistaxis, Oropharyngeal pain Gastrointestinal disorders: For full prescribing information, please visit www.

HIGHLIGHTS OF PRESCRIBING INFORMATION

ATGAM is appropriately administered into a vascular shunt, arterial venous fistula, or a high-flow central vein using an in-line filter with a pore size of 0. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing neonates and infants from ATGAM, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

The maximum tolerated dose of ATGAM Sterile Solution would be expected to vary from patient to patient due to the biological nature of the product. The dose for an elderly patient should be selected with caution, starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or packag drug therapy in this age group.

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This product’s label may have been updated. ATGAM treatment was not associated with male or female hormonal or copulation behavior changes. The range for half-life was 1. Always keep appropriate resuscitation equipment at the patient’s bedside while ATGAM is being administered.

Surgery ; 80 2: Do not administer live vaccines to patients about to receive, receiving, or after treatment with Packagr. Experience with children has been limited.

In addition, immunosuppression may be mediated by the binding of antibodies to lymphocytes which results in partial activation and induction of T lymphocyte anergy. Atfam the in-line filter with all infusions of ATGAM to prevent the administration of any insoluble material that may develop in the product during storage. Inform patients that ATGAM may cause serious allergic reactions, infection or abnormal liver or renal function.

The risk to benefit ratio must be weighed. A total of 42 patients, ages 1 to 69 years were treated. The usefulness of ATGAM has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary pac,age neoplastic disease, storage disease, myelofibrosis, Fanconi’s syndrome, or in patients known to have been exposed to myelotoxic agents or radiation.

To identify those at greatest risk imsert systemic anaphylaxis, skin testing potential recipients is strongly recommended before commencing treatment. It is the purified, concentrated, and sterile gamma globulin, primarily inswrt IgG, from hyperimmune serum of horses immunized with human thymus lymphocytes.