Myoview -

Χώρα: Νορβηγία

Γλώσσα: Νορβηγικά

Πηγή: Statens legemiddelverk

Δραστική ουσία:

Tetrofosmin

Διαθέσιμο από:

GE HEALTHCARE AS

Φαρμακολογική κατηγορία (ATC):

V09GA02

INN (Διεθνής Όνομα):

tetrofosmin

Φαρμακοτεχνική μορφή:

Pulver til injeksjonsvæske, oppløsning

Μονάδες σε πακέτο:

Hetteglass 2x0.23 mg

Τρόπος διάθεσης:

C

Καθεστώς αδειοδότησης:

Markedsført

Ημερομηνία της άδειας:

1994-10-01

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MYOVIEW
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 230 micrograms of tetrofosmin.
Excipients with known effect:
The reconstituted injection contains 3.6 – 3.7 mg/ml sodium.
For the full list of excipients, see section 6.1.
Myoview is reconstituted with Sodium Pertechnetate (
99m
Tc) Injection Ph.Eur. (not included in
this kit) to prepare technetium (
99m
Tc) tetrofosmin injection.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
A white powdery solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution with Sodium Pertechnetate (
99m
Tc) Injection the product is indicated in
adults for:
MYOCARDIAL IMAGING
Myoview is a myocardial perfusion agent indicated as an adjunct in the
diagnosis and
localization of myocardial ischaemia and/or infarction.
In patients undergoing myocardial perfusion scintigraphy, ECG-gated
SPECT can be used for
assessment of left ventricular function (left ventricular ejection
fraction and wall motion).
BREAST TUMOUR IMAGING
Myoview is indicated as an adjunct to the initial assessment (e.g.
palpation, mammography, or
alternative
imaging
modalities
and/or
cytology)
in
the
characterisation
of
malignancy
of
suspected breast lesions where all these other recommended tests were
inconclusive.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
MYOCARDIAL IMAGING
2
Patients should be requested to fast overnight or to have only a light
breakfast on the morning of
the procedure.
For diagnosis and localization of myocardial ischaemia (using planar
or SPECT techniques) and
assessment of left ventricular function using ECG-gated SPECT, the
usual procedure involves
two intravenous injections of tetrofosmin (
99m
Tc), one given at peak stress and one given at
rest. The order of the two administrations can be either rest first
and stress second or stress
first and rest second.
When rest and stress injections are administered