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
Thrombostat Warnings, Precautions, Pregnancy, Nursing, Abuse - Thrombin Topical
Thrombostat Warnings, Precautions, Pregnancy, Nursing, Abuse - Thrombin Topical
WARNINGS
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The use of topical bovine thrombin
preparations has occasionally been associated with abnormalities
in hemostasis ranging from asymptomatic alterations in laboratory
determinations, such as prothrombin time (PT) and partial thromboplastin
time (PTT), to severe bleeding or thrombosis which rarely
have been fatal. These hemostatic effects appear to be related to
the formation of antibodies against bovine thrombin and/or factor
V which in some cases may cross react with human factor V,
potentially resulting in factor V deficiency. Repeated clinical
applications of topical bovine thrombin increase the likelihood
that antibodies against thrombin and/or factor V may be formed.
Consultation with an expert in coagulation disorders is recommended
if a patient exhibits abnormal coagulation
laboratory values, abnormal bleeding, or abnormal thrombosis following
the use of topical thrombin. Any interventions should consider the
immunologic basis of this condition.
Patients with antibodies to bovine thrombin preparations should
not be re-exposed to these products.
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Because of its action in the clotting mechanism, THROMBIN-JMI®
must not be injected or otherwise allowed to enter large blood vessels.
Extensive intravascular clotting and even death may result.
PRECAUTIONS
General
Consult the Absorbable Gelatin Sponge, USP labeling for complete information
for use prior to utilizing the thrombin saturated sponge procedure.
Pregnancy
CategoryC: Animal reproduction studies have not been conducted
with THROMBIN-JMI® . It is also not known whether THROMBIN-JMI®
can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. THROMBIN-JMI® should be given to
a pregnant woman only if clearly indicated.
Pediatric Use
Safety and effectiveness in children have not been established.
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