Kidtrayze concentrate for solution for infusion

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Disponibbli minn:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

Kodiċi ATC:

B05XA31

INN (Isem Internazzjonali):

IODINE 1.96 µg/ml SELENIUM 7 µg/ml ZINC 500 µg/ml COPPER 40 µg/ml MAGNESIUM 1 µg/ml

Għamla farmaċewtika:

CONCENTRATE FOR SOLUTION FOR INFUSION

Kompożizzjoni:

IODINE 1.96 µg/ml SELENIUM 7 µg/ml ZINC 500 µg/ml COPPER 40 µg/ml MAGNESIUM 1 µg/ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Sommarju tal-prodott:

Licence number in the source country: NOT APPLICAPABLE

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2023-04-25

Fuljett ta 'informazzjoni

Kidtrayze-PIL- Common-SE/H/2192/00
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Kidtrayze 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 or nurse.
-
If your child gets any side effects, talk to your doctor or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kidtrayze is and what it is used for
2.
What you need to know before you use Kidtrayze
3.
How to use Kidtrayze
4.
Possible side effects
5.
How to store Kidtrayze
6.
Contents of the pack and other information
1.
WHAT KIDTRAYZE IS AND WHAT IT IS USED FOR
Kidtrayze is a mixture of trace elements given into the blood by a
drip (intravenous infusion). Kidtrayze
contains five trace elements (zinc, copper, manganese, selenium, and
iodine) in very small amounts which
are normally absorbed from food. These trace elements are necessary
for a normal body function.
Kidtrayze is used to meet the basic requirements of trace elements for
preterm and term neonates, infants,
children, and adolescents who cannot eat or absorb enough food through
tube feeding and thus need food
infused through their vein (called intravenous nutrition or parenteral
nutrition). Kidtrayze is added to
parenteral nutrition containing all the nutrients the body needs.
2.
WHAT YOU NEED TO KNOW BEFORE USE OF KIDTRAYZE
DO NOT USE KIDTRAYZE IF YOUR CHILD:
-
is allergic (hypersensitive) to the active substances or any of the
other ingredients of this medicine (listed
in section 6)
-
has Wilson’s disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Kidtrayze if your child has :
-
kidney problems
-
liver problems
-
reduced biliary excretion
-
thyroid problems (hyperthyroidism)
Blood levels of trace elements will be monitored regularly by your
doctor during treatment. Your doctor will
adapt the dosage of

Karatteristiċi tal-prodott

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Kidtrayze concentrate for solution for infusion
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Kidtrayze composition quantities of trace elements salts per ml and
per 10 ml ampoule:
KIDTRAYZE
1 ml
1 ampoule (10 ml)
Zinc chloride
1042 micrograms
10420 micrograms
Copper chloride dihydrate
107.4 micrograms
1074 micrograms
Manganese chloride tetrahydrate
3.600 micrograms
36.00 micrograms
Sodium selenite
15.33 micrograms
153.3 micrograms
Potassium iodide
2.567 micrograms
25.67 micrograms
The active ingredients in 1 ml of Kidtrayze correspond to:
Zinc (Zn)
7.64 micromol
500
micrograms
Copper (Cu)
0.630 micromol
40.0
micrograms
Manganese (Mn)
0.0182 micromol
1.00
micrograms
Selenium (Se)
0.0887 micromol
7.00
micrograms
Iodine (I)
0.0155 micromol
1.96
micrograms
For the full list of excipients, see section 6.1.
3.
P
HARMACEUTICAL
F
ORM
Concentrate for solution for infusion.
Clear solution, almost colourless.
•
Osmolality: approx. 40 mosm/kg water
•
pH: 2.0
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kidtrayze is indicated in preterm and term neonates, infants,
children, and adolescents in need of
intravenous nutrition to supply the basal requirements of trace
elements.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Preterm neonates: _
A recommended maximum daily dose of 1.0 mL Kidtrayze per kg body
weight covers basal
requirements of the included trace elements.
_Term neonates, infants, and children weighing less than 20 kg: _
A recommended maximum daily dose of 0.5 mL Kidtrayze per kg body
weight covers basal
requirements of the included trace elements.
Page 2 of 7
_Children weighing more than 20 kg and adolescents_
:
A recommended maximum daily dose of 10 mL Kidtrayze covers basal
requirements of the
included trace elements.
The following trace element amounts are contained in 0.5 ml, 1.0 ml,
and 10 ml Kidtrayze:
0.5 ml
1.0 ml
10 ml
Zn
250 micrograms
500 micrograms
5000 micrograms
Cu
20.0 micrograms
40.0 micrograms
400