Profilnine 500IU Intravenous Infusion

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

FACTOR IX FRACTION,DRIED

Tilgjengelig fra:

GRIFOLS MALAYSIA SDN. BHD.

INN (International Name):

FACTOR IX FRACTION,DRIED

Enheter i pakken:

5ml mL; 10 ml mL; 20 ml mL

Produsert av:

GRIFOLS BIOLOGICALS INC

Preparatomtale

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Profilnine ®
BAR CODEP/N
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, an\
d 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. Pro\
filnine ® 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 Profiln\
ine ® 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 immunodefi\
ciency 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 v