October 13, 2020

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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The incidence of toxicologic manifestations did not increase with any of these regimens; however, close monitoring of the patient innsert recommended. The effectiveness of ATGAM for reversal of acute renal allograft rejection was also demonstrated in other controlled studies performed in various medical centers.

ATGAM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Monitor patients for concurrent infection.

If therapy with ATGAM is deemed appropriate following a locally positive skin test, treatment should be administered in a setting where intensive life support facilities are immediately available and a physician familiar with the treatment of potentially life threatening allergic reactions is in attendance. Hepatitis viral, Localized infection, Systemic infection.

Flank pain, Muscle rigidity, Myalgia, Pain in extremity. While the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of ATGAM to a monkey red blood antigen. The maximum tolerated dose pacckage ATGAM Sterile Solution would be expected to vary from patient to patient due to the biological nature of the product. In this study, ATGAM was at least effective as standard therapy for treatment of acute allograft rejection.

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Flank pain, Muscle rigidity, Myalgia, Pain in extremity Renal and urinary disorders: Blood and lymphatic system disorders: Kidney enlargement, Kidney rupture, Renal failure acute.

The maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Pfizer, Inc.

Before release for clinical use, each lot of ATGAM is tested to assure its ability to inhibit rosette formation between human peripheral lymphocytes and sheep red blood cells in vitro. Due to the small sample size, the difference between the ATGAM group and the control group in functional graft survival rate did not achieve statistical significance.

The effect of ATGAM when administered in conjunction with standard therapy at the time of diagnosis of the first rejection episode was studied under two different protocols with cadaveric and living related renal transplant patients. Hyperhidrosis Musculoskeletal and connective tissue disorders: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Pediatric Nephrol ; 5: Use of antithymocyte globulin for reversal of acute allograft rejection. Observe the patient continuously for possible allergic reactions throughout the infusions [see Warnings and Precautions 5. In this patient, the administration of ATGAM was not associated with any signs of acute intoxication or late sequelae. Indication Dosage Renal transplant rejection. Use only lackage the potential benefit justifies the risk.

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Some renal transplant patients have received up to 50 doses in 4 months, and others have received day courses of 21 doses followed by as inesrt as 3 more courses for the treatment of acute rejection. 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 other drug therapy in this age group. Allocation to treatment group was based on the availability of mismatched bone marrow donors.

Always keep appropriate resuscitation equipment at the patient’s bedside while ATGAM is being administered.

Serum sickness occurred in all patients within 6 to 18 days of ATGAM initiation and was well-controlled with standard therapy. Infusion site erythema, Infusion site swelling, Pain. ATGAM is a transparent to slightly opalescent aqueous protein solution. Dyskinesia, Syncope, Tremor Cardiac disorders: Renal and ibsert disorders: Use of ATG in treatment of steroid-resistant rejection. Do not administer live vaccines to patients about to receive, receiving, or after treatment with ATGAM.

Also, skin testing done as described above will not predict for later development of serum sickness. Packabe objective of this study was to determine the efficacy of ATGAM as a single agent, in restoring hematopoiesis in patients with moderate to severe aplastic anemia.