PROFILNINE- factor ix complex kit

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

factor ix complex (UNII: FW411QXD5M) (factor ix complex - UNII:FW411QXD5M)

Tillgänglig från:

GRIFOLS USA, LLC

INN (International namn):

factor ix complex

Sammansättning:

factor ix complex 500 [iU] in 5 mL

Administreringssätt:

INTRAVENOUS

Terapeutiska indikationer:

Profilnine, Factor IX Complex, is indicated for the prevention and control of bleeding in patients with factor IX deficiency (hemophilia B). Profilnine contains non-therapeutic levels of factor VII and is not indicated for use in the treatment of factor VII deficiency. None known.

Produktsammanfattning:

Profilnine is supplied in sterile lyophilized form in single-dose vials accompanied by a suitable volume of diluent(Sterile Water for Injection, USP), according to factor IX potency. Each vial is labeled with the factor IX potency expressed in International Units which is referenced to the WHO International Standard. Profilnine is packaged with a Mix2Vial filter transfer set for use in administration. The product is available in several potencies, with carton and vial label color coded based upon assay as follows: The diluent vial stopper contains natural rubber latex. All other components of the kit are not made with natural rubber latex. Profilnine is stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 °C (77 °F). Do not freeze. Rx only

Bemyndigande status:

Biologic Licensing Application

Produktens egenskaper

PROFILNINE- FACTOR IX COMPLEX
GRIFOLS USA, LLC
----------
FACTOR IX COMPLEX
PROFILNINE
DESCRIPTION
Profilnine , Factor IX Complex, is a solvent/detergent treated,
nanofiltered, sterile,
lyophilized concentrate of coagulation factors IX, II, X, and low
levels of factor VII. The
factor II content is not more than (NMT) 150 units* per 100 factor IX
units, the factor X
content is NMT 100 units per 100 factor IX units, and the factor VII
content is NMT 35
units per 100 factor IX units. Profilnine does not contain heparin and
contains no
preservatives. Profilnine contains few, if any, activated factors
based on results from the
non-activated partial thromboplastin time (NAPTT) test
.
Profilnine is intended for intravenous administration only. Each vial
is a single-dose
container and is labeled with the factor IX potency expressed in
International Units.
Profilnine is prepared from pooled human plasma and purified by
diethylaminoethyl
(DEAE) cellulose adsorption. The risk of transmission of infective
agents by Profilnine
has been substantially reduced by donor selection procedures and virus
screening of
individual donations and plasma pools by serological and nucleic acid
testing. In addition,
virus elimination steps such as nanofiltration and solvent/detergent
(tri-n-butyl
phosphate) treatment have been incorporated into the Profilnine
manufacturing
process. Additional removal of some viruses occurs during the DEAE
cellulose product
purification step.
The ability of the manufacturing process to eliminate virus from
Profilnine was evaluated
in the laboratory by intentionally adding virus to product just prior
to the elimination step
and monitoring virus removal. Table 1 shows the amounts of virus that
can be removed
by solvent/detergent treatment, nanofiltration, and purification by
DEAE
chromatography when vesicular stomatitis virus (VSV), human
immunodeficiency virus-
1 and 2 (HIV-1, HIV-2), parvovirus, West Nile virus (WNV), bovine
viral diarrhea virus
(BVDV), hepatitis A virus (HAV), and pseudorabies virus (PRV) wer