ALPHANINE SD (coagulation factor ix- human kit

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

COAGULATION FACTOR IX HUMAN (UNII: 6U90Y1795T) (COAGULATION FACTOR IX HUMAN - UNII:6U90Y1795T)

Dostupné s:

GRIFOLS USA, LLC

INN (Mezinárodní Name):

COAGULATION FACTOR IX HUMAN

Složení:

COAGULATION FACTOR IX HUMAN 500 [iU] in 10 mL

Podání:

INTRAVENOUS

Terapeutické indikace:

AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII. None known.

Přehled produktů:

AlphaNine SD is supplied in sterile, lyophilized form in single dose vials accompanied by 10 mL diluent (Sterile Water for Injection, USP). Factor IX activity, expressed in International Units (IU) which is referenced to WHO International Standard, is stated on the label of each concentrate vial. AlphaNine SD is packaged with a Mix2Vial filter transfer set for use in administration. It is available in the following potencies, and the product is also color coded based upon assay on the carton and vial label as follows: AlphaNine SD is stable for three years, up to the expiration date printed on its label, provided that the storage temperature is between 2 and 8 °C (36 and 46 °F). Do not freeze to prevent damage to diluent vial. May be stored at room temperature not to exceed 30 °C for 1 month. When removed from refrigeration, record the date removed on the space provided on the carton. Rx only

Stav Autorizace:

Biologic Licensing Application

Charakteristika produktu

ALPHANINE SD- COAGULATION FACTOR IX (HUMAN)
GRIFOLS USA, LLC
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COAGULATION FACTOR IX (HUMAN), ALPHANINE SD
SOLVENT DETERGENT TREATED/VIRUS FILTERED
DESCRIPTION
Coagulation Factor IX (Human), AlphaNine SD, is a purified, solvent
detergent treated,
virus filtered preparation of Factor IX derived from human plasma.
It contains a
minimum of 150 IU Factor IX/mg protein; levels of Factor VII
(proconvertin), Factor II
(prothrombin) and Factor X (Stuart-Prower Factor) which are below the
limit of detection
(less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and
less than 0.05 Factor X
unit per IU Factor IX). AlphaNine SD is a sterile, lyophilized
preparation intended for
intravenous administration only. Each vial is a single dose container.
AlphaNine SD is labeled with the Factor IX potency expressed in
International Units (IU).
AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT
0.2 mg of
dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.10 μg tri(n-butyl)
phosphate/IU of
Factor IX. Contains no preservatives.
CLINICAL PHARMACOLOGY
AlphaNine SD is a purified formulation of Factor IX containing not
less than 150 IU
Factor IX activity/mg of total protein.
AlphaNine SD contains non-therapeutic levels of
Factor II, Factor VII and Factor X.
Thrombogenicity of AlphaNine SD in animals is markedly lower than that
of Factor IX
Complex, Profilnine Heat-Treated. Five lots of AlphaNine SD (three
lots of non-virus
filtered product and two lots of virus filtered product) failed to
show any evidence of
thrombogenicity when tested directly in the Wessler rabbit stasis
model for
thrombogenicity
at a dose of 200 IU Factor IX/kg body weight. When various lots of
AlphaNine SD were further tested at doses between 300 and 650 IU
Factor IX/kg, only 5
out of 40 animals (12.5%) showed evidence of thrombus formation
(Wessler scores of
+1, +2, +1, +1, +1 out of +4 maximum). In comparison, Factor IX
Complex
concentrate, Profilnine, was thrombogenic in 100% of the animals
tested at a dose of
100 IU Factor IX/kg.
At