TechneScan DMSA 1.2 mg

Țară: Norvegia

Limbă: norvegiană

Sursă: Statens legemiddelverk

Ingredient activ:

Dimerkaptosuccininsyre

Disponibil de la:

Curium Netherlands B.V.

Codul ATC:

V09EA01

INN (nume internaţional):

Dimerkaptosuccininsyre

Dozare:

1.2 mg

Forma farmaceutică:

Preparasjonssett til radioaktive legemidler

Unități în pachet:

Hetteglass 5x1.2 mg

Tip de prescriptie medicala:

C

Statutul autorizaţiei:

Markedsført

Data de autorizare:

1999-11-01

Caracteristicilor produsului

_18 CON 4341 Norway SPC 09112023_tracked.docx _
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:
Succimer (or dimercaptosuccinic acid or DMSA)
1.2 mg
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 lyophilisate.
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 of technetium (
99m
Tc)
succimer obtained is indicated in adults and children for:

Study of renal cortex morphology

Study of individual kidney function

Location of ectopic kidney.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
In adults, the recommended activity of technetium (
99m
Tc) succimer, for a patient of average weight
(70 kg), 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 _
No special dosage regimen for elderly patients is required.
_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 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 may be calculated according to the European Association of
Nuclear Medicine dosage card
(EANM 2016) by using the following formula:
_A[MBq]Administered_ = _Baseline Activity _
x
_Multiple_
(with a baseline activity of 6.8)
A minimum activity of 18.5 MBq is recommended in order to obtain
images of sufficient quality.
The resulting