Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ALBUMIN HUMAN (UNII: ZIF514RVZR) (ALBUMIN HUMAN - UNII:ZIF514RVZR)
Octapharma USA Inc
ALBUMIN - UNII:ZIF514RVZR)
ALBUMIN (HUMAN) 200 g in 1000 mL
Intravenous
ALBUMIN (HUMAN) 20% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [ 1 , 2 ] When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [ 1 ] For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, ALBUMIN (HUMAN) 20% infusions may be indicated. [ 3 ] When albumin deficit is the result of excessive protein loss, the effect of administration of ALBUMIN (HUMAN) 20% will be temporary unless the underlying disorder is reversed. ALBUMIN (HUMAN) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic f
ALBUMIN (HUMAN) 20% is supplied in 10 g in 50 mL or 20 g in 100 mL single use bottles. ALBUMIN (HUMAN) 20% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store protected from light. Do not freeze. Do not use after expiration date. Do not use if turbid.
Biologic Licensing Application
ALBUMIN (HUMAN)- ALBUMIN HUMAN SOLUTION OCTAPHARMA USA INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALBUMIN (HUMAN) 20% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUMIN (HUMAN) 20%. ALBUMIN (HUMAN) 20% FOR INFUSION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2006 INDICATIONS AND USAGE ALBUMIN (HUMAN) 20% is indicated for the restoration and maintenance of circulating blood volume for: • Hypovolemia. ( 1.1 ) • Hypoalbuminemia. ( 1.2 ) • Prevention of central volume depletion after paracentesis due to cirrhotic ascites. ( 1.3 ) • Ovarian hyperstimulation syndrome (OHSS). ( 1.4 ) • Adult respiratory distress syndrome (ARDS). ( 1.5 ) • Acute nephrosis. ( 1.6 ) • Hemolytic Disease of the Newborn (HDN). ( 1.7 ) DOSAGE AND ADMINISTRATION • Intravenous use only. • Daily dose should not exceed 2 g per kg body weight. ( 2.1 ) INDIC ATIO N DO SE Hypovole mia Adults: 25 g (2.1) Children (less than 13 years): 2.5 to 1.25 g (2.1) Hypoalbumine mia Adults: 50 to 75 g (2.1) Prevention of volume depletion after parace nte sis Adults: 8 g for every 1,000 mL of ascitic fluid removed (2.1) Ovarian hyperstimulation syndrome Adults: 50 to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary (2.1) Adult respiratory distress syndrome Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary (2.1) Acute nephrosis Adults: 25 g together with diuretic once a day for 7-10 days (2.1) Hemolytic Disease of the Newborn 1 g per kilogram body weight prior or during exchange transfusion (2.1) • Do not dilute with sterile water for injection as this may cause hemolysis in recipients. ( 5.6 ) • Store protected from light. ( 16 ) • Do not freeze. ( 16 ) • If large volumes (> 1500 ml) are administered, warm the product to room temperature before use. ( 2.2 ) • Bottles are for single use only. ( 2.2 ) DOSAGE FORMS AND STRENGTHS • 10 g in 50 mL infusion bottle ( 3 ) • 20 g in 100 mL infusion bottl Baca dokumen lengkap