ALBUMINEX- albumin human solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)

Disponible desde:

BPL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolemia following shock due to trauma or sepsis, in surgical patients and in other similar conditions with volume deficiency when restoration and maintenance of circulating blood volume is required in both adult and pediatric patients. In pediatric patients to reverse hypovolemia and achieve normal capillary refill time. 1, 2, 3, 4, 5, 6, 7, 8 ALBUMINEX 25% is indicated for prevention of central volume depletion and maintenance of cardiovascular function after large volume parencentesis in patients with liver cirrhosis or other chronic liver disease in adults and children. 9, 10, 11, 12 ALBUMINEX 25% infusion plus administration of vasoactive drugs is indicated in the treatment of type I hepatorenal syndrome. 6 For patients with spontaneous bacterial peritonitis, ALBUMINEX 25% is indicated as adjuvant treatment to antibiotic therapy.

Resumen del producto:

How ALBUMINEX 25% is supplied ALBUMINEX 25%, 25 g/dL in clear Type II glass vials. Not all pack sizes may be marketed. Storage and handling Do not store above 30°C (86°F). Keep the vial stored in the outer carton in order to protect from light. Do not freeze. Do not use ALBUMINEX 25% after the expiration date which is stated on the carton and label after "EXP." The expiration date refers to the last day of that month. ALBUMINEX 25% should be inspected visually for particulate matter and discoloration prior to administration. U.S. federal law prohibits dispensing without prescription.

Estado de Autorización:

Biologic Licensing Application

Ficha técnica

ALBUMINEX- ALBUMIN HUMAN SOLUTION
BPL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALBUMINEX 25%
ALBUMIN (HUMAN) - KJDA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ALBUMINEX 25%.
ALBUMINEX 25% (HUMAN ALBUMIN) SOLUTION FOR INJECTION. INITIAL U.S.
APPROVAL: [2018]
INDICATIONS AND USAGE
ALBUMINEX 25% is a 25% albumin solution indicated for adults and
children:
Hypovolemia (1.1)
Ascites (1.2)
Hypoalbuminemia including from burns (1.3)
Acute Nephrosis (1.4)
Acute Respiratory Distress Syndrome (ARDS) (1.5)
Cardiopulmonary Bypass (1.6)
INDICATION
DOSE
Hypovolemia
Adults: Initial dose of 25 g (including renal dialysis).
For acute liver failure: initial dose of 12 to 25 g. (2.1)
Prevention of central volume depletion after
paracentesis due to cirrhotic ascites
Adults: 8 g for every 1000 mL of ascitic fluid removed.
(2.1)
Hypoalbuminemia including from burns
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)
Acute nephrosis
Adults: 25 g together with diuretic once a day for 7-10
days. (2.1)
Adult respiratory distress syndrome (ARDS)
Adults: 25 g over 30 minutes and repeated at 8 hours for
3 days, if necessary. (2.1)
Cardiopulmonary bypass procedures
Adults: Initial dose of 25 g. (2.1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY. (2)
ALBUMINEX 25% may be diluted with 0.9% saline or 5% dextrose
(glucose). Dosage and infusion rate
should be adjusted to the patient's individual requirements. (2)
DOSAGE FORMS AND STRENGTHS
ALBUMINEX 25% is a solution for infusion: (3)
ALBUMINEX 25% contains 25 g per dL of human albumin 50 mL (12.5 g) and
100 mL (25 g) glass vials
CONTRAINDICATIONS
Hypersensitivity to human albumin or the excipients
Severe anemia or cardiac failure with normal or increased
intrav