PEDITRACE

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

COPPER CHLORIDE; MANGANESE AS CHLORIDE; POTASSIUM IODIDE; SODIUM FLUORIDE; SODIUM SELENITE ANHYDROUS; ZINC CHLORIDE

Tilgængelig fra:

CURE MEDICAL & TECHNICAL SUPPLY

ATC-kode:

B05CB10

Lægemiddelform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sammensætning:

SODIUM FLUORIDE 126 MCG/ML; SODIUM SELENITE ANHYDROUS 4.38 MCG/ML; MANGANESE AS CHLORIDE 3.6 MCG/ML; COPPER CHLORIDE 53.7 MCG/ML; POTASSIUM IODIDE 1.31 MCG/ML; ZINC CHLORIDE 521 MCG/ML

Indgivelsesvej:

I.V. INFUSION

Recept type:

Required

Fremstillet af:

FRESENIUS KABI AB, SWEDEN

Terapeutisk område:

COMBINATIONS

Terapeutiske indikationer:

Peditrace is indicated to meet the basal requirement of trace elements during intravenous nutrition of infants and children.

Autorisation dato:

2022-01-31

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Peditrace
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Peditrace contains:
Active Ingredients
Quantity
Zinc Chloride
521 µg
Copper Chloride 2H
2
0
53.7 µg
Manganese Chloride 4 H
2
0 3.60 µg
Sodium Selenite anhydrous 4.38 µg
Sodium Fluoride
126 µg
Potassium Iodide
1.31 µg
The active ingredients in 1 ml correspond to
Zn
250 µg
3.82 µmol
Cu
20 µg
0.315 µmol
Mn
1 µg
18.2
nmol
Se
2 µg
25.3
nmol
F
57 µg
3.00
µmol
I
1 µg
7.88
nmol PRODUCT PROPERTIES
Osmolality:
38 mosm/kg water
pH:
2.0
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Peditrace is indicated to meet the basal requirement of trace elements
during intravenous
nutrition of infants and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Peditrace must not be given undiluted.
The recommended dose is 1 ml Peditrace/kg body weight/day for infants
and children
with a weight of up to 15 kg. The basic requirements of trace elements
are covered by a
daily dose of 15 ml to children weighing more than 15 kg.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
Wilson’s disease.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Administration should be carried out under specialist surveillance,
especially in patients
with pre-existing imbalances, in renal failure or in hepatic disease.
Peditrace should be
used with caution in conditions where excretion in the bile is
reduced, particularly when
cholestatic liver disease is present and/or when urinary excretion is
markedly reduced.
Patients with such conditions require careful biochemical monitoring
as the excretion of
trace elements may also be significantly decreased.
Patients requiring long term total parenteral nutrition (TPN) (defined
as longer than one
month) should have a baseline whole blood or serum manganese level
within or below
the normal range and normal liver function before receiving Peditrace.
Man