Peditrace concentrate for solution for infusion

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Zinc chloride; Copper chloride 2H2O; Manganese chloride 4H2O; Sodium selenite anhydrous; Sodium fluoride; Potassium iodide

Dostupné s:

Fresenius Kabi Deutschland GmbH

ATC kód:

B05XA; B05XA31

INN (Mezinárodní Name):

Zinc chloride; Copper chloride 2H2O; Manganese chloride 4H2O; Sodium selenite anhydrous; Sodium fluoride; Potassium iodide

Dávkování:

. percent volume/volume

Léková forma:

Concentrate for solution for infusion

Terapeutické oblasti:

Electrolyte solutions; electrolytes in combination with other drugs

Stav Autorizace:

Marketed

Datum autorizace:

1995-11-13

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
PEDITRACE® CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS GIVEN.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you notice any side effects, including those not listed in this
leaflet, please tell your doctor,
pharmacist or nurse.
WHAT IS IN THIS LEAFLET
1.
What Peditrace is and what it is used for
2.
What you need to know before your child receives Peditrace
3.
How your child will be given Peditrace
4.
Possible side effects
5.
How to store Peditrace
6.
Contents of the pack and other information
1.
WHAT PEDITRACE IS AND WHAT IT IS USED FOR
Peditrace is especially designed for babies and children. It provides
trace elements to your child when
they cannot eat normally.
It is usually used as part of a balanced intravenous diet, together
with proteins, fats, carbohydrates,
salts and vitamins.
2.
WHAT YOU NEED TO KNOW BEFORE YOUR CHILD RECEIVES PEDITRACE®
YOUR CHILD SHOULD NOT RECEIVE PEDITRACE :
•
if they are allergic to Peditrace or any of the other ingredients of
this medicine (listed in section
6). IF YOUR CHILD DEVELOPS A RASH OR OTHER ALLERGIC REACTIONS (LIKE
ITCHING, SWOLLEN LIPS OR FACE
OR SHORTNESS OF BREATH), PLEASE INFORM THEIR DOCTOR, PHARMACIST OR
NURSE.
•
If they suffer from Wilson’s Disease
(AN INHERITED DISORDER WHERE THERE IS EXCESSIVE AMOUNT OF
COPPER IN THE BODY’S TISSUE)
Peditrace must be diluted before use. It will be added to another
solution before it is given to your
child. Your doctor or nurse will make sure it is prepared correctly.
WARNINGS AND PRECAUTIONS:
Talk to your doctor, pharmacist or nurse before Peditrace is given to
your child if they:
- have liver or kidney problems
Your doctor may want to do regular blood tests to check your child’s
condition.
OTHER MEDICINES AND PEDITRACE
Tell your doctor or pharmacist if your child is taking, have recently
taken or might take any other
medicines.
3.
HO

Charakteristika produktu

Health Products Regulatory Authority
18 April 2019
CRN008S1S
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Peditrace concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of Peditrace contains:
Zinc chloride
521
micrograms
Copper chloride 2H
2
O
53.7
micrograms
Manganese chloride 4H
2
O
3.60
micrograms
Sodium selenite anhydrous
4.38
micrograms
Sodium fluoride
126
micrograms
Potassium iodide
1.31
micrograms
The active ingredients in 1 ml correspond to:
Zinc
250
micrograms
3.82
micromol
Copper
20
micrograms
0.315
micromol
Manganese
1
micrograms
18.2
nmol
Selenium
2
micrograms
25.3
nmol
Flouride
57
micrograms
3.0
micromol
Iodine
1
micrograms
7.88
nmol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
A sterile, clear, colourless solution for addition to certain infusion
fluids.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Peditrace is intended to meet the basal requirements for trace
elements during intravenous nutrition of infants and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
The basal requirements for infants and children of the included trace
elements are met by 1 ml of Peditrace per kg body weight
per day to a maximum daily dose of 15 ml. A daily dose of 15 ml
Peditrace should also meet the basic needs of trace elements
in children weighing 15-40 kg. Above 40 kg the adult preparation
Additrace should be used.
Method of administration
Peditrace should not be given undiluted.
Health Products Regulatory Authority
18 April 2019
CRN008S1S
Page 2 of 4
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
Wilson’s disease.
Administration should be carried out but only under specialist
surveillance, especially in patients with pre-existing imbalances,
in renal failure or hepatic disease.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Peditrace should be used with caution in conditio