A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Feiba Vh Warnings, Precautions, Pregnancy, Nursing, Abuse - Feiba VH
Feiba Vh Warnings, Precautions, Pregnancy, Nursing, Abuse - Feiba VH
WARNINGS
Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated must
be used only in patients with circulating inhibitors to one or more coagulation
factors and should not be used for the treatment of bleeding episodes resulting
from coagulation factor deficiencies. It should not be given to patients with
significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis.
In the course of treatment with preparations containing the
prothrombin complex thromboembolic events may occur, particularly following
the administration of high doses and/or in patients with thrombotic risk factors.
Single doses of 100 units per kg of body weight of Feiba VH
and daily doses of 200 units per kg of body weight of Feiba VH should not be
exceeded. Patients receiving more than 100 units per kg of body weight of Anti-Inhibitor
Coagulant Complex, Feiba VH, Vapor Heated must be monitored for the development
of DIC and/or symptoms of acute coronary ischemia (see Adverse
Reactions section).
High doses of Feiba VH should be given only as long as absolutely
necessary to stop bleeding.
It has been reported that Anti-Inhibitor Coagulant Complex,
Feiba VH, Vapor Heated and antifibrinolytics have been given simultaneously
without complications. It is, however, recommended not to use antifibrinolytics
until 12 hours after the administration of Anti-Inhibitor Coagulant Complex,
Feiba VH, Vapor Heated.
Anamnestic responses with rise in Factor VIII inhibitor titer
have been observed in 20% of the cases (see Clinical
Pharmacology section).
This product is prepared from pooled human plasma which may
contain the causative agents of hepatitis and other viral diseases. Prescribed
manufacturing procedures utilized at the plasma collection centers, plasma testing
laboratories, and the fractionation facilities are designed to reduce the risk
of transmitting viral infection. However, the risk of viral infectivity from
this product cannot be totally eliminated.
Individuals who receive infusions of blood or plasma products
may develop signs and/or symptoms of some viral infections, particularly nonA,
nonB hepatitis.
PRECAUTIONS
Monitoring of Therapy
If clinical signs of intravascular coagulation occur, which
include changes in blood pressure, pulse rate, respiratory distress, chest pain
and cough, the infusion should be stopped promptly and appropriate diagnostic
and therapeutic measures are to be initiated.
Laboratory indications of DIC are decreased fibrinogen, decreased
platelet count, and/or presence of fibrin-fibrinogen degradation products (FDP).Other
indications of DIC include significantly prolonged thrombin time, prothrombin
time, or partial thromboplastin time.
Non Hemophilic Patients
Non hemophilic patients with acquired inhibitors against Factors
VIII,IX or XII may have both a bleeding tendency and an increased risk of thrombosis
at the same time.
Laboratory Tests and Clinical Efficacy
Tests used to control efficacy such as APTT,WBCT, and TEG do
not correlate with clinical improvement. For this reason, attempts at normalizing
these values by increasing the dose of Anti-Inhibitor Coagulant Complex, Feiba
VH,Vapor Heated may not be successful and are strongly discouraged because of
the potential hazard of producing DIC by overdosage.
Pregnancy Category C. Animal reproduction studies have
not been conducted with Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated.
It is also not known whether Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor
Heated can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated
should be given to a pregnant woman only if clearly needed.
Pediatric Use
No data are available regarding the use of Anti-Inhibitor Coagulant
Complex, Feiba VH, Vapor Heated in newborns.
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