PROLASTIN-C (alpha-1-proteinase inhibitor- human kit PROLASTIN-C (alpha-1-proteinase inhibitor- human kit

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

.alpha.1-proteinase Inhibitor Human (UNII: F43I396OIS) (.alpha.1-proteinase Inhibitor Human - UNII:F43I396OIS)

Disponibbli minn:

GRIFOLS USA, LLC

INN (Isem Internazzjonali):

.alpha.1-proteinase Inhibitor Human

Kompożizzjoni:

.alpha.1-proteinase Inhibitor Human 1000 mg in 20 mL

Indikazzjonijiet terapewtiċi:

PROLASTIN-C is an Alpha1 -Proteinase Inhibitor (Human) (Alpha1 -PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha1 -PI (alpha1 -antitrypsin deficiency). PROLASTIN-C increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1 -PI. Limitations of Use - The effect of augmentation therapy with any Alpha1 -PI, including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in Alpha1 -PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. - Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available. - PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe Alpha1 -PI deficiency has not been established. PROLASTIN-C is contraindicated in: - IgA deficient patients w

L-istatus ta 'awtorizzazzjoni:

Biologic Licensing Application

Karatteristiċi tal-prodott

PROLASTIN-C - ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
PROLASTIN-C- ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
GRIFOLS USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROLASTIN -C SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROLASTIN-C.
PROLASTIN -C (ALPHA -PROTEINASE INHIBITOR [HUMAN])
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
PROLASTIN-C is an Alpha -Proteinase Inhibitor (Human) (Alpha -PI)
indicated for chronic augmentation and
maintenance therapy in adults with clinical evidence of emphysema due
to severe hereditary deficiency of
Alpha -PI (alpha -antitrypsin deficiency). (1)
PROLASTIN-C increases antigenic and functional (anti-neutrophil
elastase capacity, ANEC) serum levels
and antigenic lung epithelial lining fluid levels of Alpha -PI.
Limitations of Use:
The effect of augmentation therapy with any Alpha -PI, including
PROLASTIN-C, on pulmonary
exacerbations and on the progression of emphysema in Alpha -PI
deficiency has not been conclusively
demonstrated in randomized, controlled clinical trials.
Clinical data demonstrating the long-term effects of chronic
augmentation or maintenance therapy with
PROLASTIN-C are not available.
PROLASTIN-C is not indicated as therapy for lung disease in patients
in whom severe Alpha -PI
deficiency has not been established.
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
Dose: 60 mg/kg body weight intravenously once per week.
Administration: 0.08 mL/kg/min as determined by patient response and
comfort.
If small particles are visible after reconstitution, remove them by
passage through a sterile filter, such as a
15 micron filter used for administering blood products (not supplied).
Dose ranging studies using efficacy endpoints have not been performed
with any Alpha -PI product,
including PROLASTIN-C. (2)
DOSAGE FORMS AND STRENGTHS
For injection: approximately 1,000 mg as lyophilized powder in a
single-u