TechneScan DTPA -

Ülke: Norveç

Dil: Norveççe

Kaynak: Statens legemiddelverk

Aktif bileşen:

Kalsiumtrinatriumpentetat

Mevcut itibaren:

Curium Netherlands B.V.

ATC kodu:

V09CA01

INN (International Adı):

Kalsiumtrinatriumpentetat

Farmasötik formu:

Preparasjonssett til radioaktive legemidler

Paketteki üniteler:

Hetteglass 5x25 mg

Reçete türü:

C

Yetkilendirme durumu:

Markedsført

Yetkilendirme tarihi:

1999-11-01

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Technescan DTPA 20.8 mg kit for radiopharmaceutical preparation.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20.8 mg pentetic acid.
To be reconstituted with sodium pertechnetate (
99m
Tc) for the preparation of the diagnostic
agent: Technetium (
99m
Tc) pentetate.
The radionuclide is not part of the kit.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Off-white to slightly yellow freeze-dried powder for solution for
injection, oral use or
inhalation.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution with sodium pertechnetate (
99m
Tc) solution, the solution of technetium
(
99m
Tc) pentetate is indicated for:
a)
After intravenous administration for:

Measurement of glomerular filtration rate

Renal perfusion and function and urinary tract studies.

Cerebral angioscintigraphy (as an alternative method when computed
tomography and/or magnetic resonance imaging are not available).
b)
After inhalation of the nebulized technetium (
99m
Tc) pentetate for:

Lung ventilation imaging.
c)
After oral administration of the technetium (
99m
Tc) pentetate for:

Detection of gastroesophageal reflux and liquid gastric emptying
study.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults and the elderly population _
The following administered activities are recommended (other
activities may be justifiable):
_For intravenous use: _

Measuring glomerular filtration rate from plasma: 7 - 18 MBq.

Renal scintigraphy: 40 - 400 MBq.

Cerebral angioscintigraphy: 185 – 740 MBq.
_For inhalation: _

Lung ventilation imaging: 500-1000 MBq deposited in the nebuliser. 50
- 100 MBq in
the lung.
_For oral use: _

Detection of gastroesophageal reflux and liquid gastric emptying
study: 10 - 20 MBq.
Technetium (
99m
Tc) pentetate is mixed with an appropriate volume (30 to 240 mL) of
liquid car