TechneScan MAG3 1 mg

Country: Նորվեգիա

language: Նորվեգերեն

source: Statens legemiddelverk

active_ingredient:

Betiatid

MAH:

Curium Netherlands B.V.

ATC_code:

V09CA03

INN:

Betiatid

dosage:

1 mg

pharmaceutical_form:

Preparasjonssett til radioaktive legemidler

units_in_package:

Hetteglass 5x1 mg

prescription_type:

C

authorization_status:

Markedsført

authorization_date:

2006-01-31

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
FOR
TECHNESCAN MAG3, 1 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION
1.
NAME OF THE MEDICINAL PRODUCT
Technescan MAG3, 1 mg kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg betiatide.
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.
Powder for solution for injection.
Off-white to slightly yellow lyophilizate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution and labelling with sodium pertechnetate (
99m
Tc) solution, the diagnostic
agent technetium (
99m
Tc) mertiatide may be used for the evaluation of nephrological and
urological disorders in particular for the study of morphology,
perfusion, function of the kidney
and characterisation of urinary outflow.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended activity for an adult weighing 70 kg is 40 to 200 MBq,
depending on the
pathology to be studied and the method to be used. Other activities
may be justifiable. Studies
of renal blood flow or transport through the ureters generally require
a larger dose than studies
of intra-renal transport, whereas renography requires smaller
activities than sequential
scintigraphy.
_Elderly population _
No special dosage-scheme is required 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 children and adolescents has to be considered carefully,
based upon clinical needs and
assessing the risk/benefit ratio in this patient group.
The activity to be administered in children and adolescents is
determined according to the EANM
dosage card (2016) using the following formula:
_The activity to be administered A[MBq] = Baseline activity (of 11.9
MBq) x Multiple _
The activities