BEBULIN VH coagulation factor ix human

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Baxter Healthcare Corporation

INN (Jina la Kimataifa):

COAGULATION FACTOR IX HUMAN

Tungo:

COAGULATION FACTOR IX HUMAN 300 [iU] in 1 mL

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

Biologic Licensing Application

Tabia za bidhaa

BEBULIN VH- COAGULATION FACTOR IX HUMAN
BAXTER HEALTHCARE CORPORATION
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BEBULIN VH
(FACTOR IX COMPLEX),
VAPOR HEATED
DESCRIPTION
BEBULIN VH (Factor IX Complex), Vapor Heated, (BEBULIN VH) is a
purified, sterile, stable,
freeze-dried concentrate of the coagulation Factors IX (Christmas
Factor) as well as II (Prothrombin)
and X (Stuart Prower Factor) and low amounts of Factor VII. In
addition, the product contains small
amounts of heparin (≤ 0.15 IU heparin per IU Factor IX).
BEBULIN VH is standardized in terms of Factor IX content and each vial
is labeled for the Factor IX
content indicated in International Units (IU). One International Unit
of Factor IX (according to the current
International Standard for Human Blood Coagulation Factors II, IX, and
X in Concentrates) corresponds
to the activity of Factor IX in 1 mL of fresh normal human plasma.
CLINICAL PHARMACOLOGY
BEBULIN VH is a combination of vitamin K-dependent clotting factors
found in normal plasma. The
administration of BEBULIN VH provides an increase in plasma levels of
Factor IX and can temporarily
correct the coagulation defect of patients with Factor IX deficiency.
Plasma levels of Factors II and X
will also be increased. However, no clinical studies have been
conducted to show benefit from this
product for treating deficiencies other than Factor IX deficiency.
_In vivo_ recovery of BEBULIN VH was determined by investigators in
Germany, Japan, and the United
States using the former International Standard, WHO 72/32 and was
found to be 53.3% ±9.6%, 57.5%
±21.8%, and 53.24% ±16.95%, respectively. In the same studies, using
different methodologies, half-
lives were determined to be 19.4 hrs ±3.8 hrs, 24.6 hrs ±3.2 hrs,
and 19.97 hrs ±8.24 hrs, respectively
.
During the manufacture BEBULIN VH is subjected to virus inactivation
by two-step vapor heating at
60°C and 80°C , where BEBULIN VH intermediate bulk is heated for a
total of 10 hours at >60°C and
1 hour at 80°C. Reduction factor for Parvovirus B19 claimed for the
Lyophilization a