Edicis 2mg kit for radiopharmaceutical preparation

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

N'n'-ethylene-(l,l) -dicysteine

Доступно од:

CIS bio International

АТЦ код:

V09CA

INN (Међународно име):

N'n'-ethylene-(l,l) -dicysteine

Дозирање:

2 milligram(s)

Фармацеутски облик:

Kit for radiopharmaceutical preparation

Тип рецептора:

Product subject to prescription which may not be renewed (A)

Терапеутска област:

Technetium (99mTc) compounds

Статус ауторизације:

Marketed

Датум одобрења:

2013-11-15

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Edicis 2mg kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Edicis vial contains 2 mg of ethylenedicysteine.
The radionuclide is not part of the kit.
Excipients with known effect
Each Edicis vial contains 3.5 mg of sodium.
Each buffer vial contains 5.2 mg of potassium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation
Edicis (red strip): White or slightly yellow powder
Reducing agent (yellow strip): White or slightly yellow powder, to be
reconstituted.
Buffer (green strip): White or yellow paste, to be reconstituted.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution and reconstitution, the solution of technetium (
99m
Tc)
- ethylenedicysteine obtained, is indicated in adults for dynamic
scintigraphy, in the following settings:
- Evaluation of nephropathies and uropathies especially for assessing
relative kidney function,
renal morphology,
and
renal perfusion
- Drainage of the upper urinary tract.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is intended for use in designated nuclear
medicine facilities only, and should only be handled
by authorised personnel.
Posology
_Adults_
The recommended activity for a patient of 70 kg average body weight is
between 90 MBq and 120 MBq.
_Elderly population_
No adaptation is recommended
I
R
I
S
H
M
E
D
I
C
I
N
E
S
B
O
A
R
D
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__