DECAN Concentrate for Soln for Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
FERROUS GLUCONATE COPPER GLUCONATE MANGANESE GLUCONATE ZINC GLUCONATE SODIUM FLUORIDE COBALT GLUCONATE SODIUM IODIDE SODIUM SELENITE AMMONIUM MOLYBDATE CHROMIUM CHLORIDE
Available from:
Baxter Healthcare Limited
Pharmaceutical form:
Concentrate for Soln for Inf
Authorization date:
2000-07-07
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DECAN concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per 1000 ml DECAN
Content per bottle of 40 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, limpid and slightly yellow solution.
Ferrous gluconate
199.9 mg
Copper gluconate
85 mg
Manganese gluconate
40.5 mg
Zinc gluconate
1742 mg
Sodium fluoride
80 mg
Cobalt II gluconate
0.280 mg
Sodium iodide
0.045 mg
Sodium selenite
3.83 mg
Ammonium molybdate
1.08 mg
Chromic chloride
1.14 mg
Density
1.00
Osmolality
19 mOsmol/kg water
Osmolarity
17.6 mOsmol/liter
DECAN
DECAN
Molar composition/40 ml
Weight composition/40 ml
Fe
17.9 micromol
1.000 mg
Zn
153.0 micromol
10.00 mg
Cu
7.550 micromol
0.480 mg
Mn
3.640 micromol
0.200 mg
F
76.30 micromol
1.450 mg
Co
0.0250 micromol
1.470 microg
I
0.0120 micromol
1.520 microg
Se
0.8870 micromol
0.070 mg
Mo
0.2610 micromol
0.025 mg
Cr
0.2890 micromol
0.015 mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/07/2011_
_CRN 2092014_
_page number: 1_
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DECAN is used as part of an intravenous nutrition regimen, to cover basal or moderate increased needs of trace
elements in parenteral nutrition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For adults only.
The recommended daily dose in patients with basal to moderately increased requirements is one vial (40 ml) of
DECAN.
In cases of significantly increased trace element requirements (such as extensive burns, severe hypercatabolic major
trauma patients) 2 vials (80 ml) of DECAN may be given per day, and monitoring of serum trace elements values is
recommended.
DECAN is not intended to
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