BERINERT- human c1-esterase inhibitor kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

HUMAN C1-ESTERASE INHIBITOR (UNII: 6KIC4BB60G) (HUMAN C1-ESTERASE INHIBITOR - UNII:6KIC4BB60G)

Commercializzato da:

CSL Behring GmbH

INN (Nome Internazionale):

HUMAN C1-ESTERASE INHIBITOR

Composizione:

HUMAN C1-ESTERASE INHIBITOR 500 [iU] in 10 mL

Indicazioni terapeutiche:

BERINERT is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adult and pediatric patients. The safety and efficacy of BERINERT for prophylactic therapy have not been established. BERINERT is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations. Risk Summary Background risk (general population) A review of available data suggests that major birth defects occur in 2-4% of the U.S. general population and that miscarriage occurs in 15-20% of clinically recognized pregnancies, regardless of drug exposure. Data Risk in BERINERT patients In a retrospective case collection study, 20 pregnant women ranging in age from 20 to 35 years received BERINERT with repeated doses up to 3,500 IU per HAE attack; these women reported no complications during delivery and no harmful effects on their 34 neonates

Dettagli prodotto:

Each product presentation includes a package insert and the following components: Storage and Handling

Stato dell'autorizzazione:

Biologic Licensing Application

Scheda tecnica

BERINERT- HUMAN C1-ESTERASE INHIBITOR
CSL BEHRING GMBH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BERINERT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BERINERT.
BERINERT [C1 ESTERASE INHIBITOR (HUMAN)]
FOR INTRAVENOUS USE. FREEZE-DRIED POWDER FOR RECONSTITUTION.
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
09/2021
INDICATIONS AND USAGE
BERINERT is a plasma-derived C1 Esterase Inhibitor (Human) indicated
for the treatment of acute
abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in
adult and pediatric patients. (1)
The safety and efficacy of BERINERT for prophylactic therapy have not
been established. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
Store the vial in the original carton in order to protect from light.
Store at 2-30°C (36-86°F). Do not
freeze. (2)
Administer 20 International Units per kg body weight. (2)
Reconstitute BERINERT prior to use using the Sterile Water for
Injection, USP provided. (2.1)
Use the silicone-free syringe provided for administration of BERINERT.
(2.1)
Administer at room temperature within 8 hours of reconstitution. (2.1)
Inject at a rate of approximately 4 mL per minute. (2.2)
Do not mix BERINERT with other medicinal products or solutions. (2.2)
Appropriately trained patients may self-administer upon recognition of
an HAE attack. (2.2)
DOSAGE FORMS AND STRENGTHS
500 International Units lyophilized concentrate in a single-dose vial
for reconstitution with 10 mL of Sterile
Water for Injection, USP. (3)
CONTRAINDICATIONS
Do not use in patients with a history of life-threatening immediate
hypersensitivity reactions, including
anaphylaxis, to C1 esterase inhibitor preparations. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions may occur. Epinephrine should be
immediately available to treat any acute
severe hypersensitivity reactions following discontinuation of
administration. (5.1)
Serious arterial and venous thromboembolic (