ALBUTEIN (albumin- human injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

GRIFOLS USA, LLC

DCI (Dénomination commune internationale):

Albumin Human

Composition:

Albumin Human 12.5 g in 250 mL

Mode d'administration:

INTRAVENOUS

indications thérapeutiques:

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

Descriptif du produit:

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.

Statut de autorisation:

Biologic Licensing Application

Résumé des caractéristiques du produit

ALBUTEIN- ALBUMIN (HUMAN) INJECTION, SOLUTION
GRIFOLS USA, LLC
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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