Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)
GRIFOLS USA, LLC
Albumin Human
Albumin Human 12.5 g in 250 mL
INTRAVENOUS
For restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 Acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. ALBUTEIN 5% can be used in such cases.1 ALBUTEIN 5% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 Preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. Albumin also may be used in the priming fluid.4,5,6 ALBUTEIN 5% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. When albumin deficit is the result of excessive protein loss, the effect of ALBUTEIN 5% administration will be temporary unless the underlying disorder is reversed.7,8,9 Septic patients and patients undergoing major surgery may
ALBUTEIN 5% is supplied in single-use, individually laser etched vials. The following vial sizes of ALBUTEIN 5% are available: NDC Number Fill Size Grams Protein 68516-5214-5 50 mL 2.5 g 68516-5214-1 250 mL 12.5 g 68516-5214-2 500 mL 25 g Each vial size label incorporates integrated hangers. Each label has a peel-off strip showing the product name and lot number. ALBUTEIN 5% is stable for three years provided the storage temperature does not exceed 30 °C. Protect from freezing.
Biologic Licensing Application
ALBUTEIN- ALBUMIN (HUMAN) INJECTION, SOLUTION GRIFOLS USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALBUTEIN 5% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALBUTEIN 5%. ALBUTEIN 5% (ALBUMIN [HUMAN] U.S.P.) 5% SOLUTION INITIAL U.S. APPROVAL: 1978 INDICATIONS AND USAGE ALBUTEIN 5% is an albumin solution indicated for: Hypovolemia. (1.1) Cardiopulmonary bypass procedures. (1.2) Hypoalbuminemia. (1.3) Plasma exchange. (1.4) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE ONLY Dosage and infusion rate should be adjusted to the patient's individual requirements. INDICATION DOSE Hypovolemia Adults: Initial dose of 20 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g. (2.1) Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. (2.1) Hypoalbuminemia Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For burn therapy after the first 24 h: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g. (2.1) Plasma exchange The dose required depends on the volume of plasma removed during the procedure. Do not dilute with sterile water for injection as this may cause hemolysis in recipients. (5.6) DOSAGE FORMS AND STRENGTHS ALBUTEIN 5% is a solution containing 50 g per L of total protein of which at least 95% is human albumin. (3) CONTRAINDICATIONS Hypersensitivity to albumin preparations or to any of the excipients. Severe anemia or cardiac failure with normal or increased intravascular volume. (4) WARNINGS AND PRECAUTIONS Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment. (5.1) Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient's volume status. Use with caution in conditions where hypervolemia and its consequences or h Prečítajte si celý dokument