Technescan DMSA 1.2 mg kit for radiopharmaceutical preparation

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Succimer

Fáanlegur frá:

Curium Netherlands B.V.

ATC númer:

V09CA; V09CA02

INN (Alþjóðlegt nafn):

Succimer

Skammtar:

1.2 milligram(s)

Lyfjaform:

Kit for radiopharmaceutical preparation

Gerð lyfseðils:

Product subject to Restricted Prescription (C)

Lækningarsvæði:

Technetium (99mTc) compounds; technetium (99mTc) succimer

Leyfisstaða:

Marketed

Leyfisdagur:

1999-01-22

Upplýsingar fylgiseðill

16-APP-4341-Ireland-PIL-15052019_clean.doc
DRN 4341
PACKAGE LEAFLET: INFORMATION FOR THE USER
TECHNESCAN DMSA
1.2 mg kit for radiopharmaceutical preparation
Dimercaptosuccinic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your Nuclear medicine doctor
who will supervise the procedure.
-
If you get any side effects, talk to your Nuclear medicine doctor.
This includes any possible side effects not listed in this leaflet.
IN THIS LEAFLET:
1.
What Technescan DMSA is and what it is used for
2.
What you need to know before Technescan DMSA is used
3.
How Technescan DMSA is used
4.
Possible side effects
5.
How Technescan DMSA is stored
6.
Contents of the pack and other information
1.
WHAT TECHNESCAN DMSA IS AND
WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
Technescan DMSA is used through a scan to examine the:
•
KIDNEYS
The
use
of
Technescan
DMSA
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 outweights the risk due to
radiation.
This medicine is a powder. When mixed by qualified people with a
solution of the radioactive substance, sodium pertechnetate (
99m
Tc) it
forms DMSA-[
99m
Tc]technetium. When administered into the body it
collects in certain organs such as the kidneys.
The radioactive substance can be photographed from outside the
body, using special cameras which take a scan. This scan shows the
distribution of radioactivity within the organ and body. This gives
the
doctor valuable information about the structure and function of that
organ.
2.
WHAT YOU NEED TO KNOW BEFORE
TECHNESCAN DMSA IS USED
TECHNESCAN DMSA MUST NOT BE USED
•
allergic (hypersensitive) to dimercaptosuccinic acid or any of
the other ingredients of this medicine (listed

Vara einkenni

Health Products Regulatory Authority
20 November 2020
CRN00C1KP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Technescan DMSA 1.2 mg kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains:
Dimercaptosuccinic acid 1.2 mg.
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.
Greyish white to slightly yellow pellets or powder.
To be reconstituted with sodium pertechnetate (
99m
Tc) solution for injection (not included in this kit).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution, the solution obtained is indicated for:
· Static (planar or tomographic) renal imaging
· Morphological studies of renal cortex
· Individual kidney function
· Location of ectopic kidney.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
In adults, the recommended activity is 30 to 120 MBq. Other activities
may be justifiable. It should be noted that in each
country physicians should follow the Diagnostic Reference Levels and
the rules set up by local law.
Elderly population
There is no special dosage regimen for the elderly patient.
Renal impairment
Careful consideration of the activity to be administered is required
since an increased radiation exposure is possible in these
patients.
Paediatric population
The use in paediatric children and adolescents has to be considered
carefully, based upon clinical needs and assessing the
risk/benefit ratio in this patient group. The activities to be
administered to children and to adolescents were calculated
according to the EANM dosage card (2008) by using the following
formula:
_A_[_MBq_]ADMINISTERED = _Baseline Activity _x _Multiple_ (with a
baseline activity of 17.0)
The resulting activities to be administered may be found in the
following table:
Health Products Regulatory Authority
20 Novembe