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
Indications, Dosage, Storage, Stability - Pediatrace
Indications, Dosage, Storage, Stability - Pediatrace
INDICATIONS
Pedtrace®-4 is indicated for use as a supplement to intravenous solution
given for TPN. Administration of Pedtrace®-4 in TPN solutions helps to
maintain plasma levels of zinc, copper, manganese, and chromium and to
prevent depletion of endogenous stores of these trace elements and subsequent
deficiency symptoms in pediatric patients.
DOSAGE AND ADMINISTRATION
The suggested dosage ranges for the four trace elements in neonates and
pediatric patients are:
| ZINC: |
For full term infants and children up to 5 years of
age, 100 mcg zinc/kg/day is recommended. For premature infants up
to 3 kg in body weight, 300 mcg zinc/kg/day is suggested. |
| COPPER: |
For pediatric patients, the suggested additive dosage
level is 20 mcg copper/kg/day. |
| MANGANESE: |
For pediatric patients, a dosage of 2 to 10 mcg manganese/kg/day
is suggested. |
| CHROMIUM: |
For pediatric patients, the suggested additive dosage
is 0.14 to 0.20 mcg/kg/day |
Periodic monitoring of plasma levels of zinc, copper, manganese and chromium
is suggested as a guideline preparation.
Aseptic addition of Pedtrace®-4 to the TPN solution under a laminar wflow
hood is recommended. The trace elements present in Pedtrace®-4 are physically
compatible with the electrolytes and vitamins usually present in the amino
acid/dextrose solution used for TPN.
Parenteral drug products should be visually inspected for particulate
matter and discoloration prior to administration, whenever solution and
container permit.
HOW SUPPLIED
|
Product No.
|
NDC No.
|
|
|
13803
|
0469-1380-03
|
Pedtrace®-4 in a 3 mL single-dose, flip-top vial in
packages of 25. |
|
13810
|
0469-1380-30
|
Pedtrace®-4 in a 10 mL single-dose, flip-top vial in
packages of 25. |
Store at controlled room temperature 15°-30°C (59°-86°F).
Preservative Free. Discard unused portion.
CAUTION: Federal law prohibits dispensing without prescription.
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