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
Ic-Green Warnings, Precautions, Pregnancy, Nursing, Abuse - Tricarbocyanine
Ic-Green Warnings, Precautions, Pregnancy, Nursing, Abuse - Tricarbocyanine
WARNINGS
Two anaphylactic deaths have been reported following IC-GREEN™ administration during cardiac catheterization. One of these was in
a patient with a history of sensitivity to penicillin and sulfa drugs.
The Aqueous Solvent provided for this proiduct, pH 5.5 to 6.5, which is especially
prepared Sterile Water for Injection, should be used to dissolve IC-GREEN™ because
there have been reports of incompatibility with some commercially available
Water for Injection.
PRECAUTIONS
General: IC-GREEN™ Powder and Solution: IC-GREEN™ is unstable in aqueous solution and must be used within 10 hours.
However, the dye is stable in plasma and whole blood so that samples obtained
in discontinuous sampling techniques may be read hours later. Sterile techniques
should be used in handling the dye solution as well as in the performance of
the dilution curves.
IC-GREEN™ (sterile indocyanine green) powder may cling to the vial or lump
together because it is freeze-dried in the vials. This is not due to the
presence of water the moisture content is carefully controlled.
Heparin preparations containing sodium bisulfate reduce the absorption peak
of IC-GREEN™ in blood and, therefore, should not be used as an anticoagulant
for the collection of samples for analysis.
The plasma fractional disappearance rate at the recommended 0.5 mg/kg dose
has been reported to be significantly greater in women than in men, although
there was no significant difference in the calculated value for clearance.
Radioactive iodine uptake studies should not be performed for at least a week
following the use of IC-GREEN™.
Pregnancy Category C: Animal Reproduction studies have not
been conducted with IC-GREEN™. It is also not known whether IC-GREEN™ can cause
fetal harm when administered to a pregnant woman or can affect reproduction
capacity. IC-GREEN™ should be given to a pregnant woman only if clearly indicated.
Nursing Mothers: It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human milk, caution should
be exercised when IC-GREEN™ is administered to a nursing woman.
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