Technescan MIBI 1mg kit for radiopharmaceutical preparation

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TETRAKIS, METHOXY ISOBUTYL, ISONITRILE, COPPER, TETRAFLUOROLBORATE

Available from:

Curium Netherlands B.V Westerduinweg 3, 1755 LE Petten, Netherlands

ATC code:

V09GA01

INN (International Name):

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

Pharmaceutical form:

KIT FOR RADIOPHARMACEUTICAL PREPARATION

Composition:

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

Prescription type:

POM

Therapeutic area:

DIAGNOSTIC RADIOPHARMACEUTICALS

Authorization status:

Withdrawn

Authorization date:

2009-05-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Technescan MIBI 1 mg, kit for radiopharmaceutical preparation
[Tetrakis(2-methoxy-2-methylpropyl-1 isocyanide)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 Technescan MIBI is and what it is used for
2.
What you need to know before Technescan MIBI is used
3.
How Technescan MIBI is used
4.
Possible side effects
5.
How Technescan MIBI is stored
6.
Contents of the pack and other information
1.
WHAT TECHNESCAN MIBI IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
Technescan
MIBI
contains
a
substance
called
[tetrakis(1-isocyanide-2-methoxy-2-
methylpropy)copper(I)] tetrafluoroborate which 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).
Technescan
MIBI
is
also
used
in
the
diagnosis of breast
abnormalities in addition to other diagnostic methods when the results
are unclear. Technescan
MIBI can also be used to find the position of overactive parathyroid
glands (glands that secrete the
hormone that controls blood calcium levels).
After Technescan MIBI 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 an image
(scintigraphy) of the concerned organ which

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Technescan MIBI 1 mg Kit for radiopharmaceutical preparation.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg [Tetrakis(2-methoxy-2-methylpropyl-1
isocyanide)copper(I)]
tetrafluoroborate.
The radionuclide is not part of the kit.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
White to almost white pellets or powder.
To be reconstituted with sodium pertechnetate (
99m
Tc) solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only. This is 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:
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_Diagnos