Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)
Pfizer Laboratories Div Pfizer Inc
Intravenous
PANZYGA is indicated for treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. PANZYGA is indicated for the treatment of adult patients with ITP to raise platelet counts to control or prevent bleeding. PANZYGA is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment. - PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. - PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity . Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted
PANZYGA is supplied in 1 g, 2.5 g, 5 g, 10 g, 20 g, and 30 g single-use bottles. The table below shows the details of available presentations of PANZYGA. PANZYGA is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose a filter size of 0.2-200 microns. Components used in the packaging of PANZYGA are not made with natural rubber latex. Store PANZYGA for 36 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within its shelf-life, the product may be stored at ≤ +25°C (77°F) for up to 12 months. After storage at ≤ +25°C (77°F), either use immediately or discard the product. Do not use after expiration date. Do not freeze. Do not use frozen product. PANZYGA contains no preservatives. The PANZYGA bottle is for single use only. Use promptly any bottle that has been entered or opened, and discard partially used bottles. Dispose of any unused product or waste material in accordance with local requirements.
Biologic Licensing Application
PANZYGA- IMMUNE GLOBULIN INTRAVENOUS (HUMAN) SOLUTION PFIZER LABORATORIES DIV PFIZER INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PANZYGA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PANZYGA. PANZYGA, (IMMUNE GLOBULIN INTRAVENOUS, HUMAN - IFAS) 10% LIQUID PREPARATION INITIAL U.S. APPROVAL: 2018 WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ - THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN INTRAVENOUS (IGIV) PRODUCTS, INCLUDING PANZYGA. RISK FACTORS MAY INCLUDE: ADVANCED AGE, PROLONGED IMMOBILIZATION, HYPERCOAGULABLE CONDITIONS, HISTORY OF VENOUS OR ARTERIAL THROMBOSIS, USE OF ESTROGENS, INDWELLING VASCULAR CATHETERS, HYPERVISCOSITY, AND CARDIOVASCULAR RISK FACTORS. - RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROPATHY, AND DEATH MAY OCCUR WITH THE ADMINISTRATION OF IGIV PRODUCTS IN PREDISPOSED PATIENTS. RENAL DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY IN PATIENTS RECEIVING IGIV PRODUCTS CONTAINING SUCROSE. PANZYGA DOES NOT CONTAIN SUCROSE. -FOR PATIENTS AT RISK OF THROMBOSIS, RENAL DYSFUNCTION, OR RENAL FAILURE, ADMINISTER PANZYGA AT THE MINIMUM INFUSION RATE PRACTICABLE. ENSURE ADEQUATE HYDRATION IN PATIENTS BEFORE ADMINISTRATION. MONITOR FOR SIGNS AND SYMPTOMS OF THROMBOSIS AND ASSESS BLOOD VISCOSITY IN PATIENTS AT RISK FOR HYPERVISCOSITY. RECENT MAJOR CHANGES Indications and Usage (1) 01/2021 Dosage and Administration, Dose (2.1) 01/2021 INDICATIONS AND USAGE PANZYGA is an immune globulin intravenous (human) - ifas 10% liquid preparation indicated for the treatment of: • Primary humoral immunodeficiency (PI) in patients 2 years of age and older ( 1.1 ). • Chronic immune thrombocytopenia (ITP) in adults ( 1.2 ). • Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults (1.3) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE ONLY ( 2 ). INDICATION DOSE INITIAL INFUSION RATE MAXIMUM INFUSION RATE (AS TOLERATED) PI 300- Прочетете целия документ