Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
.ALPHA.1-PROTEINASE INHIBITOR HUMAN (UNII: F43I396OIS) (.ALPHA.1-PROTEINASE INHIBITOR HUMAN - UNII:F43I396OIS)
Takeda Pharmaceuticals America, Inc.
.ALPHA.1-PROTEINASE INHIBITOR HUMAN
.ALPHA.1-PROTEINASE INHIBITOR HUMAN 1 g in 50 mL
INTRAVENOUS
GLASSIA is an Alpha1 -Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1 -PI, also known as alpha1 -antitrypsin (AAT) deficiency. Limitations of Use : - The effect of augmentation therapy with GLASSIA or any Alpha1 -PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1 -PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. - Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available. - GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1 -PI deficiency has not been established. GLASSIA is contraindicated in: - immunoglobulin A (IgA) deficient patients with antibodies against IgA. - individuals with a history of anaphylaxis or other severe systemic reaction to Alpha1 -PI products. Risk Summar
Each carton of GLASSIA contains a single-dose vial containing approximately 1 gram of functional Alpha1 -PI in 50 mL of solution (NDC 0944-2884-01).
Biologic Licensing Application
GLASSIA- .ALPHA.1-PROTEINASE INHIBITOR HUMAN INJECTION, SOLUTION TAKEDA PHARMACEUTICALS AMERICA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GLASSIA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLASSIA. GLASSIA (ALPHA -PROTEINASE INHIBITOR (HUMAN)) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2010 RECENT MAJOR CHANGES Indications and Usage, Increase serum levels of Alpha -PI (1) 9/2023 INDICATIONS AND USAGE GLASSIA is an Alpha -Proteinase Inhibitor (Human) (Alpha -PI) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha -PI (alpha -antitrypsin deficiency). (1) Limitations of Use: The effect of augmentation therapy with any Alpha -PI, including GLASSIA, on pulmonary exacerbations and on the progression of emphysema in alpha -antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. (1) Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available. (1) GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha -PI deficiency has not been established. (1) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE ONLY. (2) Dose = 60 mg/kg body weight intravenously once weekly. (2.1) Administer at a rate not to exceed 0.2 mL/kg body weight per minute, depending on patient response and comfort. (2.3) Dose ranging studies using efficacy endpoints have not been performed. (2.1) Always use a 5 micron in-line filter (minimum filter diameter of 32 mm to ensure optimal performance, not supplied) during infusion. (2.3) If adverse events occur, reduce the rate or interrupt the infusion until the symptoms subside. Resume the infusion at a rate tolerated by the patient. (2.3) DOSAGE FORMS AND STRENGTHS For injection: Approximately 1 gram of functional Alpha -PI in 50 mL of ready to use solution Կարդացեք ամբողջական փաստաթուղթը