MONONINE- coagulation factor ix human kit

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

coagulation factor IX human (UNII: 6U90Y1795T) (coagulation factor IX human - UNII:6U90Y1795T)

Prieinama:

CSL Behring LLC

INN (Tarptautinis Pavadinimas):

coagulation factor IX human

Sudėtis:

coagulation factor IX human 500 [iU] in 5 mL

Terapinės indikacijos:

MONONINE is indicated for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease. MONONINE is not indicated in the treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII. MONONINE contains non-detectable levels of Factors II, VII and X (<0.0025 IU per Factor IX unit using standard coagulation assays) and is, therefore, not indicated for replacement therapy of these clotting factors. MONONINE is also not indicated in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors. Known hypersensitivity to mouse protein is a contraindication to MONONINE.

Produkto santrauka:

MONONINE is supplied in a single dose vial with Sterile Water for Injection, USP, and a Mix2Vial filter transfer set for reconstitution and withdrawal. Factor IX activity in IU is stated on the carton and vial label. Each product package consists of the following:

Autorizacija statusas:

Biologic Licensing Application

Prekės savybės

MONONINE- COAGULATION FACTOR IX HUMAN
CSL BEHRING LLC
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COAGULATION FACTOR IX (HUMAN)
MONONINE
MONOCLONAL ANTIBODY PURIFIED
R ONLY
DESCRIPTION
Coagulation Factor IX (Human), MONONINE is a sterile, stable,
lyophilized concentrate of Factor IX
prepared from pooled human plasma and is intended for use in therapy
of Factor IX deficiency, known
as Hemophilia B or Christmas disease. MONONINE is purified of
extraneous plasma-derived proteins,
including Factors II, VII and X, by use of immunoaffinity
chromatography. A murine monoclonal
antibody to Factor IX is used as an affinity ligand to isolate Factor
IX from the source material. Factor
IX is then dissociated from the monoclonal antibody, recovered,
purified further, formulated and
provided as a sterile, lyophilized powder. The immunoaffinity protocol
utilized results in a highly pure
Factor IX preparation. It shows predominantly a single component by
SDS polyacrylamide
electrophoretic evaluation and has a specific activity of not less
than 190 Factor IX units per mg total
protein.
All Source Plasma used in the manufacture of this product was tested
by FDA-licensed Nucleic Acid
Testing (NAT) for HBV, HCV, and HIV-1 and found to be nonreactive
(negative).
This concentrate has been processed by monoclonal antibody
immunoaffinity chromatography during its
manufacture, which has been shown to be capable of reducing the risk
of viral transmission.
Additionally, a chemical treatment protocol and nanofiltration used in
its manufacture have also been
shown to be capable of significant virus reductions. However, no
procedure has been shown to be
totally effective in removing the risk of viral infectivity from
coagulation factor concentrates (see
CLINICAL PHARMACOLOGY and WARNINGS).
MONONINE is a purified preparation of Factor IX. When stored as
directed, it will maintain its labeled
potency for the period indicated on the container label.
Each vial contains the labeled amount of Factor IX activity expressed
in International Units (IU). One IU
represents the activity o