Junyelt, Concentrate for solution for infusion

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Zinc gluconate; Copper gluconate; Manganese Gluconate; Potassium iodide; Sodium selenite

Tillgänglig från:

Laboratoire AGUETTANT

ATC-kod:

B05XA; B05XA31

INN (International namn):

Zinc gluconate; Copper gluconate; Manganese Gluconate; Potassium iodide; Sodium selenite

Dos:

Unknown

Läkemedelsform:

Concentrate for solution for infusion

Receptbelagda typ:

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

Terapiområde:

Electrolyte solutions; electrolytes in combination with other drugs

Bemyndigande status:

Marketed

Tillstånd datum:

2017-03-24

Bipacksedel

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
JUNYELT, CONCENTRATE FOR SOLUTION FOR INFUSION
(FOR PRETERM, AND TERM NEWBORNS, INFANTS AND CHILDREN)
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 JUNYELT, Concentrate for
solution for infusion, but will be referred
as JUNYELT throughout the whole leaflet.
WHAT IS IN THIS LEAFLET
1.
What JUNYELT is and what it is used for
2.
What you need to know before you use JUNYELT
3.
How to use JUNYELT
4.
Possible side effects
5.
How to store JUNYELT
6.
Contents of the pack and other information
1.
WHAT JUNYELT IS AND WHAT IT IS USED FOR
JUNYELT is a concentrate for solution for infusion, especially
designed for preterm and term newborns,
infants and children.
It contains five trace elements (zinc, copper, manganese, iodine,
selenium), which are considered as essential
because the body cannot produce them but needs them in very small
quantities in order to function properly.
Trace elements are normally provided by a balanced diet.
JUNYELT is used to provide trace elements to preterm and term
newborns, infants and children who cannot
eat normally and need intravenous (into a vein) feeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE JUNYELT
_ _
YOUR CHILD SHOULD NOT RECEIVE
JUNYELT:

if he/she is
allergic (hypersensitive) to any of the ingredients of JUNYELT (See
section 6 of this leaflet).

if he/she suffers from Wilson’s disease (an inherited disorder where
there is excessive amount of copper
in the body).

if he

Produktens egenskaper

Health Products Regulatory Authority
18 June 2021
CRN00C816
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Junyelt, Concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition of Junyelt expressed in quantities of salts per ampoule
(10 ml) and per ml.
Theoretical quantities of raw
materials EXPRESSED IN
ANHYDROUS
JUNYELT
For 1 ampoule
(microgram/10 ml)
For 1 ml
(microgram)
Zinc gluconate
6970
697.0
Copper gluconate
1428
142.8
Manganese gluconate
40.52
4.052
Potassium iodide
13.08
1.308
Sodium selenite
43.81
4.381
Content per ampoule of 10 ml
JUNYELT
Molar composition
(micromol/10 ml)
JUNYELT
Weight composition
(microgram/10 ml)
Zinc (Zn)
15.30
1000
Copper (Cu)
3.15
200
Manganese (Mn)
0.091
5
Iodine (I)
0.079
10
Selenium (Se)
0.253
20
Content per ml
JUNYELT
Molar composition
(micromol/ml)
JUNYELT
Weight composition
(microgram/ml)
Zinc (Zn)
1.53
100
Copper (Cu)
0.315
20
Manganese (Mn)
0.0091
0.5
Iodine (I)
0.0079
1
Selenium (Se)
0.0253
2
Each ml of solution contains 1.16 microgram equivalent to 0.0506
micromol of sodium.
Each 10 ml ampoule contains 11.6 microgram equivalent to 0.506
micromol of sodium.
Each ml of solution contains 0.31 microgram equivalent to 0.008
micromol of potassium.
Each 10 ml ampoule contains 3.1 microgram equivalent to 0.08 micromol
of potassium.
For a full list of excipients, see section 6.1.
Health Products Regulatory Authority
18 June 2021
CRN00C816
Page 2 of 6
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless solution.
Density
1.0
pH
2.7 to 3.3
Osmolality
15 mosmol/kg
Osmolarity
15 mosmol/L
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Junyelt is used as part of the intravenous nutrition of preterm and
term newborns, infants and children. It is intended to meet
the basal requirements for trace elements.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
PRETERM, AND TERM NEWBORNS, INFANTS AND CHILDREN (WEIGHING 20 KG OR
LESS):
Basal requirements of the included trace elements are covered by