KEDBUMIN (albumin- human injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

ALBUMIN HUMAN (UNII: ZIF514RVZR) (ALBUMIN HUMAN - UNII:ZIF514RVZR)

Saadav alates:

Kedrion S.p.A

INN (Rahvusvaheline Nimetus):

ALBUMIN - UNII:ZIF514RVZR)

Koostis:

ALBUMIN (HUMAN) 12.5 g in 50 mL

Manustamisviis:

INTRAVENOUS

Näidustused:

For restoration and maintenance of circulating blood volume where volume deficiency is demonstrated and colloid use is appropriate. KEDBUMIN® is indicated for severe albumin deficiency caused by illness or active bleeding. When albumin deficiency results from excessive protein loss, the effect of albumin administration will be temporary unless the underlying disorder is reversed. KEDBUMIN® is indicated for maintenance of cardiovascular function following the removal of large volumes of ascitic fluid due to cirrhosis [1, 2]. KEDBUMIN® is indicated as a plasma expander in the fluid management of severe forms of ovarian hyperstimulation syndrome (OHSS) [3, 4]. KEDBUMIN® is indicated in conjunction with diuretics to correct fluid volume overload associated with ARDS [5]. KEDBUMIN® is indicated after > 24 hours post burn in patients experiencing severe albumin depletion in order to favor edema re-absorption [6]. KEDBUMIN® is indicated in patients undergoing long term dialysis or for those patients who are fl

Toote kokkuvõte:

KEDBUMIN® is supplied as a sterile, aqueous solution for single dose intravenous administration containing 0.25 g per mL human albumin. It is available in the following glass vial size: 50 mL vial 25% (NDC 76179-025-01) is packaged in one carton (NDC 76179-025-02) 100 mL vial 25% (NDC 76179-025-03) is packaged in one carton (NDC 76179-025-04) Storage Do not use KEDBUMIN® 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. 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.

Volitamisolek:

Biologic Licensing Application

Toote omadused

KEDBUMIN- ALBUMIN (HUMAN) INJECTION, SOLUTION
KEDRION S.P.A
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KEDBUMIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KEDBUMIN [ALBUMIN
(HUMAN) U.S.P.]
STERILE, AQUEOUS SOLUTION FOR SINGLE DOSE INTRAVENOUS ADMINISTRATION
INITIAL U.S. APPROVAL: JUNE, 2011.
INDICATIONS AND USAGE
KEDBUMIN is a 25% albumin solution indicated for:
Hypovolemia (1.1) and 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)
Burns (1.6)
Hemodialysis patients undergoing long term dialysis (1.7)
Patients who cannot tolerate substantial volumes of salt solution
(1.7)
Priming as part of a cardiopulmonary bypass fluids (1.8)
DOSAGE AND ADMINISTRATION
Intravenous Administration Only. KEDBUMIN may be diluted with 5%
glucose or 0.9% sodium chloride.
Concentration, dosage, and infusion-rate should be adjusted to the
patient's individual requirements and
indication (2.1). Daily dosage should not exceed 2g per kg body
weight.
INDICATION: DOSE
HYPOVOLEMIA:
Adults: Initial dose 25 g is suggested.
HYPOALBUMINEMIA:
50-75 g
PREVENTION OF CENTRAL
VOLUME DEPLETION AFTER
PARACENTESIS DUE TO
CIRRHOTIC ASCITES:
Adults: 6-8 g for every 1000 mL of ascitic fluid removed
OHSS:
Adults: 50 to 100 g over 4 hours and repeated at 4-12 hour intervals
as
necessary. 10-50 g; single infusion
ARDS:
Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days if
necessary
BURNS:
Determined by direct observation of vital sign or measurement of
either
plasma oncotic pressure or protein content
HEMODIALYSIS:
100 mL
CARDIOPULMONARY BYPASS:
Estimated from the difference between the desired and actual total
serum
protein concentration times the estimated plasma volume (approx 40mL
per kg) times 2
DOSAGE FORMS AND STRENGTHS
KEDBUMIN is a sterile, single dose solution containing 0.25 g per mL
human albu