RIASTAP- fibrinogen human injection, powder, lyophilized, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K)

Tilgængelig fra:

CSL Behring GmbH

INN (International Name):

FIBRINOGEN HUMAN

Sammensætning:

FIBRINOGEN HUMAN 1300 mg in 50 mL

Indgivelsesvej:

INTRAVENOUS

Terapeutiske indikationer:

RIASTAP® , Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Limitation of Use RIASTAP is not indicated for dysfibrinogenemia. RIASTAP is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products. Risk Summary There are no studies of RIASTAP use in pregnant women. Animal reproduction studies have not been conducted with RIASTAP. It is not known whether RIASTAP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is no information regarding the presence of RIASTAP in human milk, its effects on the breastfed infant, or its effects on mi

Produkt oversigt:

The product presentation includes a package insert and the following component:

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

RIASTAP- FIBRINOGEN HUMAN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CSL BEHRING GMBH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIASTAP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RIASTAP.
RIASTAP, FIBRINOGEN CONCENTRATE (HUMAN)
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Indications and Usage (1)
06/2021
Dosage and Administration (2.2)
07/2020
INDICATIONS AND USAGE
RIASTAP, Fibrinogen Concentrate (Human) is a human blood coagulation
factor indicated for the
treatment of acute bleeding episodes in pediatric and adult patients
with congenital fibrinogen deficiency,
including afibrinogenemia and hypofibrinogenemia. (1)
RIASTAP is not indicated for dysfibrinogenemia.
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
Dose (mg/kg body weight) =
[Target level (mg/dL) - measured level (mg/dL)]
1.7 (mg/dL per mg/kg body weight)
Dose when fibrinogen level is unknown: 70 mg/kg body weight. (2.1)
Monitoring of patient's fibrinogen level is recommended during
treatment. A target fibrinogen level of
100 mg/dL should be maintained until hemostasis is obtained. (2.1)
Injection rate should not exceed 5 mL per minute. (2.3)
DOSAGE FORMS AND STRENGTHS
RIASTAP is available as a single-dose vial containing 900 mg to 1300
mg lyophilized fibrinogen
concentrate powder for reconstitution. (3)
The actual fibrinogen potency for each lot is printed on the vial
label and carton. (3)
CONTRAINDICATIONS
Known anaphylactic or severe systemic reactions to human
plasma-derived products (4)
WARNINGS AND PRECAUTIONS
Monitor patients for early signs of anaphylaxis or hypersensitivity
reactions and if necessary,
discontinue administration and institute appropriate treatment. (5.1)
Thrombotic events have been reported in patients receiving RIASTAP.
Weigh the benefits of
administration versus the risks of thrombosis. (5.2)
Because RIASTAP is made from human blood, it may carry a risk of
transmittin