Infutraze concentrate for solution for infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Copper chloride dihydrate; Manganese chloride tetrahydrate; Potassium iodide; Sodium selenite anhydrous; Zinc chloride

Dostupné z:

Fresenius Kabi Deutschland GmbH

ATC kód:

B05XA31

INN (Medzinárodný Name):

Copper chloride dihydrate; Manganese chloride tetrahydrate; Potassium iodide; Sodium selenite anhydrous; Zinc chloride

Forma lieku:

Concentrate for solution for infusion

Terapeutické oblasti:

electrolytes in combination with other drugs

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2023-06-30

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Infutraze 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 Infutraze is and what it is used for
2.
What you need to know before you use Infutraze
3.
How to use Infutraze
4.
Possible side effects
5.
How to store Infutraze
6.
Contents of the pack and other information
1.
WHAT INFUTRAZE IS AND WHAT IT IS USED FOR
Infutraze is a mixture of trace elements given into the blood by a
drip (intravenous infusion). Infutraze
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.
Infutraze 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). Infutraze is added to
parenteral nutrition containing all the nutrients the body needs.
2.
WHAT YOU NEED TO KNOW BEFORE USE OF INFUTRAZE
DO NOT USE INFUTRAZE 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 Infutraze 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 Infutraze accordingly.
CHILDREN AND

Súhrn charakteristických

Health Products Regulatory Authority
02 February 2024
CRN00DQV6
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Infutraze concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Infutraze composition quantities of trace elements salts per ml and
per 10 ml ampoule:
INFUTRAZE
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 Infutraze 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 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear solution, almost colourless.
• Osmolality: approx. 40 mosm/kg water
• pH: 2.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Infutraze 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 Infutraze 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 Infutraze per kg body
weight covers basal requirements of the included trace
elements.
_Children weighing more than 20 kg and adolescents_:
A recommended maximum daily dose of 10 mL Infutraze covers basal
requirements of the included trace elements.
Health Products Regulatory Authority
02 February 2024
CRN00DQV6
Page 2 of 5
The following trace element amounts are contained in 0.5 ml, 1.0 ml,
and 10 ml Infutra