PROLASTIN-C LIQUID (alpha1-proteinase inhibitor- human injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

GRIFOLS USA, LLC

INN (Միջազգային անվանումը):

.alpha.1-proteinase Inhibitor Human

Կազմը:

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

Կառավարման երթուղին:

INTRAVENOUS

Թերապեւտիկ ցուցումներ:

PROLASTIN® -C LIQUID 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). Limitations of Use - The effect of augmentation therapy with any Alpha1 -PI, including PROLASTIN-C LIQUID, 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 LIQUID are not available. - PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe Alpha1 -PI deficiency has not been established. PROLASTIN-C LIQUID is contraindicated in: - IgA deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity. - Patients with a history of anaphylaxis or other sever

Լիազորման կարգավիճակը:

Biologic Licensing Application

Ապրանքի հատկությունները

PROLASTIN-C LIQUID- ALPHA1-PROTEINASE INHIBITOR (HUMAN) INJECTION,
SOLUTION
GRIFOLS USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROLASTIN-C LIQUID
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PROLASTIN-C LIQUID.
PROLASTIN-C LIQUID (ALPHA -PROTEINASE INHIBITOR [HUMAN])
SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
PROLASTIN -C LIQUID 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)
Limitations of Use:
The effect of augmentation therapy with any Alpha -PI, including
PROLASTIN-C LIQUID, 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 LIQUID are not available.
PROLASTIN-C LIQUID 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 ONLY. (2)
Dose: 60 mg/kg body weight intravenously once per week. (2.1)
Dose ranging studies using efficacy endpoints have not been performed
with any Alpha -PI product,
including PROLASTIN-C LIQUID. (2.1)
Administration: 0.08 mL/kg/min as determined by patient response and
comfort. (2.3)
DOSAGE FORMS AND STRENGTHS
For injection: approximately 500 mg (10 mL), 1,000 mg (20 mL) and
4,000 mg (80 mL) of a solution for
injection in single-dose vials. (3)
CONTRAINDICATIONS
Immunoglobulin A (IgA) deficient patients with antibodies against IgA.
(4)
History of anaphylaxis or other severe systemic reaction to Alpha -PI.
(4)
WARNINGS AND PRECAUTIONS
Severe hypersensitivity and anaphylactic reactions may occur in IgA
deficient patients w