MYOVIEW

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

TETROFOSMIN

Tilgængelig fra:

TUNGGAL IDAMAN ABDI - Indonesia

INN (International Name):

TETROFOSMIN

Dosering:

0.23 MG

Lægemiddelform:

SERBUK INJEKSI

Enheder i pakken:

KIT @ 5 VIAL @ 0,23 MG

Fremstillet af:

GE HEALTHCARE AS - Norway

Autorisation dato:

2021-02-15

Produktets egenskaber

PRESENTATION
Each
vial
contains
230
micrograms
tetrofosmin
(active
ingredient),
0.03mg stannous
chloride
dihydrate,
0.32mg
disodium
sulphosalicylate, 1.0mg sodium D-gluconate and 1.8mg sodium hydrogen
carbonate as a freeze-dried mixture sealed under nitrogen.
Radiopharmaceutical kit - powder for solution for injection following
reconstitution with 4-8ml of sterile Sodium Pertechnetate [
99m
Tc]
Injection
Ph.
Eur. at
a radioactive concentration not
exceeding 1.5GBq/ml to yield
99m
Tc-tetrofosmin injection,
a diagnostic
radiopharmaceutical imaging agent.
The product is supplied in a 10ml clear glass vial. Packs of 2 and 5
vials are available. Labels for the reconstituted product and
sanitizing
swabs (containing 70% isopropyl alcohol B.P.) are provided.
MANUFACTURER
GE HEALTHCARE AS
Oslo Plant Nycoveien 1
NO-0485 Oslo
Norway
INDICATIONS
This medicinal product is for diagnostic use only.
_Myocardial Imaging:_
_ _
Myoview is a myocardial perfusion agent indicated as an adjunct in the
diagnosis and localization of myocardial ischaemia and/or
infarction.
_Breast Tumour Imaging: _
Myoview is indicated as an adjunct to the initial assessments (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.
CONTRA-INDICATIONS
Myoview is contraindicated in pregnancy and in patients with known
hypersensitivity to tetrofosmin or any of the excipients.
PRECAUTIONS FOR USE
Breast lesions less than 1cm in diameter may not all be detected with
scintimammography as the sensitivity of Myoview for the detection
of these lesions is 36% (n=5 of 14, 95% CI 13% to 65%) relative to
histological diagnosis. A negative examination does not exclude
breast cancer especially in such a small lesion. Efficacy in the
identification of auxiliary lesions has not been proven, consequently
scintimammography is not indicated for staging breast cancer.
In myocardial scintigraphy investigations under stress conditio