TechneScan DTPA 20.8 mg kit for radiopharmaceutical preparation

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

PENTETIC ACID

Предлага се от:

Curium Netherlands B.V.

АТС код:

V09CA01; V09EA01

INN (Международно Name):

PENTETIC ACID

дозиране:

20.8 milligram(s)

Лекарствена форма:

Kit for radiopharmaceutical preparation

Вид предписание :

Product subject to Restricted Prescription (C)

Терапевтична област:

technetium (99mTc) pentetic acid; technetium (99mTc) pentetic acid

Статус Оторизация:

Marketed

Дата Оторизация:

1999-01-22

Листовка

DRN 4362
TECHNESCAN DTPA IRELAND
PAGE 1 OF 2
04362007BYS10a /
23 CON 4362 Ireland SPC 28062021 / 22 CON 4362 Ireland PIL 09062021
Package leaflet: Information for the user
TECHNESCAN
DTPA
Kit for radiopharmaceutical preparation,
pentetic acid 20.8 mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist. See scetion 4.
WHAT IS iN THIS LEAFLET:
1.
What TechneScan DTPA is and what it is used for
2.
What you need to know before Technescan DTPA is used
3.
How Technescan DTPA is used
4.
Possible side effects
5.
How Technescan DTPA is stored
6.
Contents of the pack and other information
1.
WHAT TECHNESCAN DTPA IS AND WHAT IT
IS USED FOR
This medicine is a radiopharmaceutical for DIAGNOSTIC USE only.
TechneScan DTPA is used for scanning to examine:

KIDNEYS

BRAIN

LUNGS

GATROESOPHAGUS REFLUX and GASTRIC EMPTYING
This medicine is a non-radioactive powder. When mixed by qualified
personnel,
with a solution of the radioactive substance, sodium pertechnetate (
99m
Tc) it
forms Technetium [
99m
Tc] pentetate. When administered into the body it collects
in certain organs such as, the kidneys or the brain.
The radioactive substance can be photographed (scanned) from outside
the
body, using special cameras. This scan shows the distribution of
radioactivity
within the organ and body. This also gives the doctor valuable
information about
the structure and function of that organ.
The use of Technescan DTPA does involve exposure to small amounts of
radioactivity. Your doctor and the nuclear medicine doctor have
considered that
the clinical benefit that you will obtain from the procedure with the
radiopharmaceutical outweighs the risk due to radiation.
2.
WHAT DO YOU NEED TO KNOW BEFORE
TECHNESCAN DTPA IS USED
TECHNESCAN DTPA MUST NOT B

Данни за продукта

Health Products Regulatory Authority
21 September 2021
CRN00CL3Z
Page 1 of 11
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:
Pentetic acid 20.8 mg
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 a 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 gastro-oesophageal reflux and liquid gastric emptying
study.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY
In adults and the elderly population, the following administered
activities are recommended (other activities may be justifiable):
_For intravenous route_

Measurement of 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 lung.
Health Products Regulatory Authority
21 September 2021
CRN00CL3Z
Page 2 of 11
_For oral use_

Detection of gastro-oesophageal reflux and li