INJECTION ALPHANINE SD 1000 IU

Country: Malaysia

Language: English

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

Active ingredient:

FACTOR IX COMPLEX

Available from:

GRIFOLS MALAYSIA SDN. BHD.

INN (International Name):

FACTOR IX COMPLEX

Units in package:

20ml mL

Manufactured by:

Grifols Biologicals LLC

Summary of Product characteristics

Alphanine
®
SD
DESCRIPTION
Coagulation Factor IX (Human), AlphaNine
®
SD, is a purified, solvent detergent treated, virus filtered
preparation of Factor IX derived
from human plasma.
1
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 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.
CLINICAL PHARMACOLOGY
AlphaNine
®
SD is a purified formulation of Factor IX containing not less than 150
IU Factor IX activity/mg of total protein.
2
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
3-6
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 a dose of 200 IU Factor IX/kg body weight in a porcine model, the
heptane heat-treated formulation of this product (AlphaNine
®
)
showed little evidence of disseminated intravascular coagulation (DIC)
following infusi