Profilnine 1000 IU Intravenous Infusion

Ország: Malajzia

Nyelv: angol

Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktív összetevők:

FACTOR IX FRACTION,DRIED

Beszerezhető a:

GRIFOLS MALAYSIA SDN. BHD.

INN (nemzetközi neve):

FACTOR IX FRACTION,DRIED

db csomag:

5ml mL; 10 ml mL; 20 ml mL

Gyártó:

Grifols Biologicals LLC

Termékjellemzők

G
G
B
B
Profilnine
®
DESCRIPTION
Factor IX complex, Profilnine
®
, 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
®
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
®
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.
1, 2
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, specific,
effective virus elimination steps such as nanofiltration
3
and solvent/detergent (tri-n-butyl phosphate/TNBP) treatment
4
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),
parvo virus, West Nile virus (WNV), bovine viral diarrhea virus
(BVDV), hepatitis A virus (HAV) and pseudorabies virus
(PRV) were evaluate