SUPPLYELT Concentrate for Soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ZINC GLUCONATE, COPPER GLUCONATE, MANGANESE GLUCONATE, SODIUM FLUORIDE, POTASSIUM IODIDE, SODIUM SELENITE, FERROUS GLUCONATE, SODIUM MOLYBDATE 2H2O, CHROMIUM CHLORIDE 6H2O

Available from:

Laboratoire AGUETTANT

ATC code:

B05XA31

INN (International Name):

ZINC GLUCONATE, COPPER GLUCONATE, MANGANESE GLUCONATE, SODIUM FLUORIDE, POTASSIUM IODIDE, SODIUM SELENITE, FERROUS GLUCONATE, SO

Pharmaceutical form:

Concentrate for Soln for Inf

Prescription type:

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

Therapeutic area:

electrolytes in comb with other drugs

Authorization status:

Authorised

Authorization date:

2016-01-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUPPLYELT, CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet.
See section 4.
The name of this medicinal product is SUPPLYELT, concentrate for
solution for infusion, but will be
referred as SUPPLYELT throughout the whole leaflet
What is in this leaflet
1.
What SUPPLYELT is and what it is used for
2.
What you need to know before you use SUPPLYELT
3.
How to use SUPPLYELT
4.
Possible side effects
5.
How to store SUPPLYELT
6.
Contents of the pack and other information
1.
WHAT SUPPLYELT IS AND WHAT IT IS USED FOR
SUPPLYELT is a concentrate for solution for infusion.
It contains 9 essential trace elements (iron, copper, manganese, zinc,
fluorine, iodine, selenium,
chromium, molybdenum).
These trace elements are considered as essential because the body
cannot produce them but needs
them in very small quantities in order to function properly.
SUPPLYELT is used to provide trace elements in adults needing
intravenous (into a vein) feeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SUPPLYELT
DO NOT USE SUPPLYELT:
-
if you are allergic (hypersensitive) to any of the ingredients of
SUPPLYELT (See section 6 of
this leaflet).
-
if your body weight is less than 40 kg.
-
if you have abnormally high level of any of the ingredients of the
product in your blood. (If you
have any doubt, ask your doctor).
-
if you have a pronounced cholestasis (yellowing of the skin or whites
of the eyes caused by liver
or blood problem).
-
if you have an excess of copper (Wilson´s disease) or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Supplyelt Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of Supplyelt expressed in quantities of salts per ampoule
(10 ml) and per litre.
Content per ampoule of 10 ml
Fe
18
1000
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, limpid 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
Theoretical quantities of raw
materials EXPRESSED IN ANHYDROUS
SUPPLYELT
For 1 ampoule
(microgram/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
Supplyelt
Supplyelt
Molar composition
(micromol /10 ml)
Weight composition
(microgram /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
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4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Supplyelt
is used as part
of an intravenous nutrition regimen,
to cover basal
or moderately increased trace element
requirements in parenteral nutrition.
Supplyelt