ARALAST NP (alpha-1-proteinase inhibitor- human kit

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

.ALPHA.1-PROTEINASE INHIBITOR HUMAN (UNII: F43I396OIS) (.ALPHA.1-PROTEINASE INHIBITOR HUMAN - UNII:F43I396OIS)

Доступна с:

Takeda Pharmaceuticals America, Inc.

ИНН (Международная Имя):

.ALPHA.1-PROTEINASE INHIBITOR HUMAN

состав:

.ALPHA.1-PROTEINASE INHIBITOR HUMAN 16 mg in 1 mL

Терапевтические показания :

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

Обзор продуктов:

How Supplied ARALAST NP is available in the following kits: Each kit contains a suitable volume of Sterile Water for Injection, USP diluent (25 mL for 0.5 gram vial; 50 mL for 1 gram vial), one sterile double-ended transfer needle, one sterile 20 micron filter needle and one package insert. Storage and Handling

Статус Авторизация:

Biologic Licensing Application

Характеристики продукта

ARALAST NP- ALPHA-1-PROTEINASE INHIBITOR (HUMAN)
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARALAST NP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARALAST NP.
ARALAST NP (ALPHA -PROTEINASE INHIBITOR (HUMAN))
FOR INTRAVENOUS USE. LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Dosage and Administration, Reconstitution (2.2)
12/2022
Dosage and Administration, Administration (2.3)
12/2022
INDICATIONS AND USAGE
ARALAST NP is an Alpha -Proteinase Inhibitor (Human) (Alpha -PI)
indicated for chronic augmentation
therapy in adults with clinically evident emphysema due to severe
congenital deficiency of Alpha -PI
(alpha -antitrypsin deficiency). ARALAST NP increases antigenic and
functional (anti-neutrophil elastase
capacity, ANEC) serum levels and antigenic lung epithelial lining
fluid levels of Alpha -PI. (1)
The effect of augmentation therapy with any Alpha -PI, including
ARALAST NP, on pulmonary
exacerbations and on the progression of emphysema in alpha
-antitrypsin deficiency has not been
conclusively demonstrated in randomized, controlled clinical trials.
(1)
Clinical data demonstrating the long-term effects of chronic
augmentation and maintenance therapy of
individuals with ARALAST NP or ARALAST are not available. (1)
ARALAST NP is not indicated as therapy for lung disease in patients in
whom severe Alpha -PI deficiency
has not been established. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
Recommended dosage is 60 mg/kg body weight administered once weekly by
intravenous infusion.
(2.1)
Administer at a rate not to exceed 0.2 mL/kg body weight/minute, and
as determined by the response
and comfort of the patient. (2.3)
DOSAGE FORMS AND STRENGTHS
Available as a lyophilized powder in single dose vials containing 0.5
gram or 1 gram of functional Alpha -PI.
(3)
CONTRAINDICATIONS
Immunoglobulin A (IgA) deficient patients with antibodies again