البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
ALBUMIN HUMAN (UNII: ZIF514RVZR) (ALBUMIN HUMAN - UNII:ZIF514RVZR)
Baxalta US Inc.
ALBUMIN HUMAN
ALBUMIN HUMAN 0.25 g in 1 mL
Biologic Licensing Application
BUMINATE- ALBUMIN HUMAN INJECTION, SOLUTION BAXALTA US INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUMINATE 25% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUMINATE 25%. BUMINATE 25% ALBUMIN (HUMAN), USP, 25% SOLUTION FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1954 INDICATIONS AND USAGE BUMINATE 25%, Albumin (Human) Solution is indicated for: Hypovolemia (1.1) Hypoalbuminemia: Burns, Adult Respiratory Distress Syndrome (ARDS) and Nephrosis (1.2) Cardiopulmonary Bypass Surgery (1.3) Hemolytic Disease of the Newborn (HDN) (1.4) Limitations of Use: Albumin is not indicated as an intravenous nutrient.(1.5) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE ONLY Adjust dose and rate of infusion based on the patient's clinical status. (2.1) Do not exceed 2 g of albumin per kg body weight for the daily dose. (2.1) Do not exceed 1 mL/min for patients with normal blood volume. (2.1) Do not dilute with Sterile Water for Injection. (2.2) INDIC ATIO N DO SE Hypovolemic Shock Infants and young children: 2.5 to 5 mL per kg body weight. Older children and adults: initial dose 100 to 200 mL. Repeat after 15 to 30 minutes if the response is not adequate. Hypoalbumine mia Calculate the body albumin compartment to be 80 to 100 mL per kg body weight. Do not exceed a daily dose of 2 g of albumin per kg of body weight. Burns: The dosage should be determined according to the patient's condition and response to treatment after the first 24 hours. Hemolytic Disease of the Newborn 1 g per kg body weight prior to or during exchange transfusion. DOSAGE FORMS AND STRENGTHS BUMINATE 25% is a solution containing 25 g of albumin per each 100 mL. (3) CONTRAINDICATIONS History of hypersensitivity reaction to albumin preparations or to any of the excipients (N-acetyltryptophan and sodium caprylate). (4) Severe anemia or cardiac failure with normal or increased intravascular volume. (4) Do not administer to patients with chronic renal insufficiencies due to the اقرأ الوثيقة كاملة