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
Warnings, Precautions, Pregnancy, Nursing, Abuse - Pediatrace
Warnings, Precautions, Pregnancy, Nursing, Abuse - Pediatrace
WARNINGS
Pedtrace®-4 is a hypotonic solution which should be administered in admixtures
only. Supplementation of TPN solutions with Pedtrace®-4 should be immediately
discontinued if toxicity symptoms due to any of the constituent trace
elements in Pedtrace®-4 is observed in the patient.
PRECAUTIONS
• Before administering Pedtrace®-4 in TPN solutions, the physician
must assess the metabolic requirements of trace elements and disease
state of the patient. Frequent determinations of serum levels of the
four trace elements are suggested as a guideline for adjusting the dosage
or completely omitting Pedtrace®-4. Zinc is eliminated via the intestine
and kidneys; copper and manganese are eliminated mainly via the bile;
and chromium primarily via the kidneys. The possibility of their retention
should be considered in patients with malfunctioning excretory routes
of the respective trace elements.
• Syringes equipped with aluminum needles or hubs should not be used,
as the solution is acidic.
Pregnancy Category C
Animal reproduction studies have not been conducted with Pedtrace®-4.
It is also not known whether Pedtrace®-4 can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Pedtrace®-4 should
be given to a pregnant woman only if clearly needed.
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