NUTRYELT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CHROMIUM CHLORIDE; COPPER GLUCONATE; FERROUS GLUCONATE; MANGANESE GLUCONATE; POTASSIUM IODIDE; SODIUM FLUORIDE; SODIUM MOLYBDATE; SODIUM SELENITE; ZINC GLUCONATE

Available from:

REMEDIX CARE LTD

ATC code:

B05XA31

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

FERROUS GLUCONATE 7988.2 MCG / 10 ML; CHROMIUM CHLORIDE 30.45 MCG / 10 ML; SODIUM MOLYBDATE 42.93 MCG / 10 ML; SODIUM SELENITE 153.32 MCG / 10 ML; POTASSIUM IODIDE 170.06 MCG / 10 ML; SODIUM FLUORIDE 2099.5 MCG / 10 ML; MANGANESE GLUCONATE 445.69 MCG / 10 ML; COPPER GLUCONATE 2142.4 MCG / 10 ML; ZINC GLUCONATE 69700 MCG / 10 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABORATOIRE AGUETTANT, FRANCE

Therapeutic area:

ELECTROLYTES IN COMBINATION WITH OTHER DRUGS

Therapeutic indications:

NUTRYELT is used as part of an intravenous nutrition regimen, to cover basal or moderately increased trace element requirements in parenteral nutrition. NUTRYELT is indicated in adults only

Authorization date:

2019-08-08

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
NUTRYELT
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of NUTRYELT expressed in quantities of salts per ampoule
(10 ml) and per litre.
Theoretical quantities of raw
materials
EXPRESSED IN ANHYDROUS
NUTRYELT
For 1 ampoule
(µg/10 ml)
For 1 litre
(mg)
Zinc gluconate
69700
6970.0
Copper gluconate
2142.4
214.24
Manganese gluconate
445.69
44.569
Sodium fluoride
2099.5
209.95
Potassium iodide
170.06
17.006
Sodium selenite
153.32
15.332
Sodium molybdate
42.93
4.293
Chromium chloride
30.45
3.045
Ferrous gluconate
7988.2
798. 82
Content per ampoule of 10 ml
NUTRYELT
NUTRYELT
Molar composition
(μmol /10 ml)
Weight composition
(μg /10 ml)
Zn
153
10000
Cu
4.7
300
Mn
1.0
55
F
50
950
I
1.0
130
Se
0.9
70
Mo
0.21
20
Cr
0.19
10
Fe
18
1000
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clearand and slightly yellow solution.
Density
1.0
pH
2.6 to 3.2
Osmolality
60 to 100 mosm/kg
Osmolarity
60 to 100 mosm/l
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
NUTRYELT is used as part of an intravenous nutrition regimen, to cover
basal or moderately increased
trace element requirements in parenteral nutrition.
NUTRYELT is indicated in adults only.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For adults only.
The recommended daily dose in patients with basal to moderately
increased requirements is one ampoule
(10 ml) of NUTRYELT.
In cases of significantly increased trace element requirements (such
as extensive burns, patients in severe
hypercatabolic state due to major trauma) 2 ampoules (20 ml) of
NUTRYELT may be given per day,
and monitoring of serum trace element level is recommended.
In patients with renal, hepatic impairments or mild cholestasis the
posology should be adapted (see
section 4.4).
_Paediatric population _
NUTRYELT is contraindicated in children and adolescents (see section
4.3).
A specific paediatric product should be used for trace element
supplementation in the paediatric
population during parentera