PEDITRACE CONCENTRATE FOR SOLUTION FOR INFUSION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ZINC CHLORIDE ; CUPRIC CHLORIDE DIHYDRATE ; MANGANESE CHLORIDE TETRAHYDRATE ; SODIUM SELENITE PENTAHYDRATE ; SODIUM FLUORIDE ; POTASSIUM IODIDE

Available from:

Fresenius Kabi Limited

ATC code:

B05XA31

INN (International Name):

ZINC CHLORIDE ; CUPRIC CHLORIDE DIHYDRATE ; MANGANESE CHLORIDE TETRAHYDRATE ; SODIUM SELENITE PENTAHYDRATE ; SODIUM FLUORIDE ; POTASSIUM IODIDE

Dosage:

%v/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

electrolytes in combination with other drugs

Authorization status:

Marketed

Authorization date:

1995-11-13

Patient Information leaflet

562
660
15816012H.indd 1
2016-06-03 14:50:57
15816012H.indd 2
2016-06-03 14:50:57

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Peditrace concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
A sterile, clear, colourless solution for addition to certain infusion
fluids.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Peditrace is intended to meet the basal requirements for trace
elements during intravenous nutrition of infants and
children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
The basal requirements for infants and children of the included trace
elements are met by 1 ml of Peditrace per kg body
weight per day to a maximum daily dose of 15 ml.
A daily dose of 15 ml Peditrace should also meet the basic needs of
trace elements in children weighing 15-40 kg.
Above 40 kg the adult preparation Additrace should be used.
Method of administration
Peditrace should not be given undiluted.
Each 1 ml of Peditrace contains:
Zinc chloride
521
micrograms
Copper chloride 2H
2
O
53.7
micrograms
Manganese chloride 4H
2
O
3.60
micrograms
Sodium selenite anhydrous
4.38
micrograms
Sodium fluoride
126
micrograms
Potassium iodide
1.31
micrograms
The active ingredients in 1 ml correspond to:
Zinc
250
micrograms
3.82
micromol
Copper
20
micrograms
0.315
micromol
Manganese
1
micrograms
18.2
nmol
Selenium
2
micrograms
25.3
nmol
Flouride
57
micrograms
3.0
micromol
Iodine
1
micrograms
7.88
nmol
For the full list of excipients, see section 6.1.
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