Peditrace Concentrate for Soln for Inf

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

POTASSIUM IODIDE, COPPER CHLORIDE, ZINC CHLORIDE, MANGANESE CHLORIDE, SODIUM FLUORIDE, SODIUM SELENITE

Mevcut itibaren:

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

ATC kodu:

B05XA31

INN (International Adı):

POTASSIUM IODIDE 1.31 µg/ml COPPER CHLORIDE 53.7 µg/ml ZINC CHLORIDE 521 µg/ml MANGANESE CHLORIDE 3.6 µg/ml SODIUM FLUORIDE 126 µg/ml SODIUM SELENITE 4.38 µg/ml

Farmasötik formu:

CONCENTRATE FOR SOLUTION FOR INFUSION

Kompozisyon:

POTASSIUM IODIDE 1.31 µg/ml COPPER CHLORIDE 53.7 µg/ml ZINC CHLORIDE 521 µg/ml MANGANESE CHLORIDE 3.6 µg/ml SODIUM FLUORIDE 126 µg/ml SODIUM SELENITE 4.38 µg/ml

Reçete türü:

POM

Terapötik alanı:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2006-12-21

Bilgilendirme broşürü

Package Leaflet: Information for the User
PEDITRACE
R
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 yur 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
R
Your child should not receive Peditrace.

If they are allergic to Peditrace or the other ingredients of this
medicine (listed in section
6). IF YOUR CHILD DEVELOPS A RASH OR OTHER ALLERGIC REACTION (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.
WARNING 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.
HOW YOUR CH

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Peditrace concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of Peditrace contains:
Active Ingredients
Quantity
Zinc Chloride
521
µ
g
Copper Chloride 2H
2
0
53.7
µ
g
Manganese Chloride 4 H
2
0
3.60
µ
g
Sodium Selenite anhydrous
4.38
µ
g
Sodium Fluoride
126
µ
g
Potassium Iodide
1.31
µ
g
The active ingredients in 1 ml correspond to
Zn
250
µ
g
3.82
µ
mol
Cu
20
µ
g
0.315
µ
mol
Mn
1
µ
g
18.2 nmol
Se
2
µ
g
25.3 nmol
F
57
µ
g
3.00
µ
mol
I
1
µ
g
7.88 nmol
Product Properties
Osmolality:
38 mosm/kg water
pH:
2.0
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for infusion.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Peditrace is an integral part of the complete intravenous nutrition of
infants
and children. It is intended to meet basal requirements for trace
elements and
should be used in conjunction with amino acid or glucose solutions or
other
paediatric admixtures.
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly: _
The trace element solution Additrace should be used in adults and
elderly.
_ _
_Paediatric population: _
_Infants and children (weighing 15kg or less): _
Basal requirements of the included trace elements are covered by 1 ml
Peditrace per kg body weight per day to a maximum daily dose of 15 ml.
Children (weighing 15 kg or more):
A daily dose of 15 ml Peditrace should meet basal trace element
requirements.
However, for patients weighing more than 40 kg the adult preparation
Additrace should be used.
Method of administration
Peditrace should not be given undiluted.
Peditrace administration should not be started until kidney function
is
established – usually during the second day of life.
The infusion should be given at a very slow rate (minimum infusion
period is
8 hours) and is best done with an appropriate pump or an automatic
drop rate
counter.
As the requirements of trace elements may vary in different clinical
conditi