Peditrace

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

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

Доступна с:

Fresenius Kabi Limited

код АТС:

B05XA

ИНН (Международная Имя):

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

Фармацевтическая форма:

CONCENTRATE FOR SOLUTION FOR INFUSION

состав:

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

Тип рецепта:

POM

Терапевтические области:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Статус Авторизация:

Authorised

Дата Авторизация:

2006-12-21

тонкая брошюра

562
660
15816012H.indd 1
2016-03-14 14:31:06
15816012H.indd 2
2016-03-14 14:31:07

Характеристики продукта

Page 1 of 6
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

g
Copper Chloride 2H
2
0
53.7

g
Manganese Chloride 4 H
2
0
3.60

g
Sodium Selenite anhydrous
4.38

g
Sodium Fluoride
126

g
Potassium Iodide
1.31

g
The active ingredients in 1 ml correspond to
Zn
250

g
3.82

mol
Cu
20

g
0.315

mol
Mn
1

g
18.2 nmol
Se
2

g
25.3 nmol
F
57

g
3.00

mol
I
1

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.
Page 2 of 6
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