ALBUMINEX- albumin human solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

BPL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

ALBUMINEX 5% 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 5% 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 5% infusion plus administration of vasoactive drugs is indicated in the treatment of type I hepatorenal syndrome. 6 For patients with spontaneous bacterial peritonitis, ALBUMINEX 5% is indicated as adjuvant treatment to antibiotic therapy. 9,

Přehled produktů:

How ALBUMINEX 5% is supplied ALBUMINEX 5%, 5 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 5% 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 5% should be inspected visually for particulate matter and discoloration prior to administration. U.S. federal law prohibits dispensing without prescription.

Stav Autorizace:

Biologic Licensing Application

Charakteristika produktu

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 5% ALBUMIN
(HUMAN) - KJDA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ALBUMINEX 5%.
ALBUMINEX 5% (HUMAN ALBUMIN) SOLUTION FOR INJECTION.
INITIAL U.S. APPROVAL: [2018]
INDICATIONS AND USAGE
ALBUMINEX 5% is a 5% 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)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
ALBUMINEX 5% may be diluted with 0.9% saline or 5% dextrose (glucose).
Dosage and infusion rate should be adjusted to the patient's
individual requirements.
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 FORMS AND STRENGTHS
ALBUMINEX 5% is a solution for infusion: (3)
ALBUMINEX 5% contains 5 g per dL of human albumin in 250 mL (12.5 g)
and 500 mL (25 g) glass vials
CONTRAINDICATIONS
Hypersensitivity to human albumin or the excipients
Severe anemia or cardiac failure with normal or increased
intravascular volum