MIBITop 1 mg kit for radiopharmaceutical preparation

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TETRAKIS, METHOXY ISOBUTYL, ISONITRILE, COPPER, TETRAFLUOROLBORATE

Available from:

Institute of Isotopes Co. Ltd H-1121 Budapest, Konkoly-Thege Miklós út 29-33, Hungary

ATC code:

V09GA01

INN (International Name):

TETRAKIS (2-METHOXY ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROLBORATE 1 mg

Pharmaceutical form:

KIT FOR RADIOPHARMACEUTICAL PREPARATION POWDER FOR SOLUTION FOR INJECTION

Composition:

TETRAKIS (2-METHOXY ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROLBORATE 1 mg

Prescription type:

POM

Therapeutic area:

DIAGNOSTIC RADIOPHARMACEUTICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-12-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIBITOP 1MG KIT FOR RADIOPHARMACEUTICAL PREPARATION
[tetrakis (1-isocyanide-2-methoxy-2-methylpropyl-)copper(I)]
tetrafluoroborate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What MIBITop is and what it is used for
2.
What you need to know before MIBITop is used
3.
How MIBITop is used
4.
Possible side effects
5.
How MIBITop is stored
6.
Contents of the pack and other information
1.
WHAT MIBITOP IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
MIBITop contains active substance called
[tetrakis(1-isocyanide-2-methoxy-2-methylpropy)copper(I)]
tetrafluoroborate which is radiolabelled with sodium pertechnetate (
99m
Tc) solution obtaining the
injection
of technetium (
99m
Tc) sestamibi is used to study the heart function and blood flow
(myocardial perfusion) by making an image of the heart (scintigraphy),
for example in the detection of
heart attacks (myocardial infarctions) or when a disease causes
reduced blood supply to (a part of) the
heart muscle (ischaemia). MIBITop is also used in the diagnosis of
breast abnormalities in addition to
other diagnostic methods when the results are unclear. MIBITop can
also be used to find the position
of overactive parathyroid glands (glands that secrete the hormone that
controls blood calcium levels).
After MIBITop is injected, it temporarily collects in certain parts of
the body. This
radiopharmaceutical substance contains a small amount of
radioactivity, which can be detected from
outside of the body by using special cameras. Your nuclear medicine
doctor will then take

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
MIBITop 1 mg kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg [tetrakis
(1-isocyanide-2-methoxy-2-methylpropyl-)copper(I)]
tetrafluoroborate.
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.
White to almost white pellets or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only. It is primarily
indicated for adults. For paediatric
population see section 4.2.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution, the solution of technetium (
99m
Tc)
sestamibi obtained is indicated for:
•
Myocardial perfusion scintigraphy for the detection and localisation
of coronary artery disease
(angina pectoris and myocardial infarction)
•
Assessment of global ventricular function. First-pass technique for
determination of ejection
fraction and/or ECG-triggered, gated SPECT for evaluation of left
ventricular ejection fraction,
volumes and regional wall motion.
•
Scintimammography for the detection of suspected breast cancer when
mammography is
equivocal, inadequate or indeterminate.
•
Localisation of hyperfunctioning parathyroid tissue in patients with
recurrent or persistent
disease in both primary and secondary hyperparathyroidism, and in
patients with primary
hyperparathyroidism scheduled to undergo initial surgery of the
parathyroid glands.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults and elderly population _
Posology may vary depending on gamma camera characteristics and
reconstruction modalities. The
injection of activities greater than local DRLs (Diagnostic Reference
Levels) should be justified.
The recommended activity range for intravenous administration to an
adult patient of average weight
(70 kg) is for:
_ _
_Diagnosis of reduced coronary perfusion and myocardial infarction _
400-9