Technescan MIBI 1mg kit for radiopharmaceutical preparation

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Tetrakis (2-methylopropyl-isocyanide) copper (i) tetrafluoroborate

זמין מ:

Curium Netherlands B.V.

קוד ATC:

V09GA01

INN (שם בינלאומי):

Tetrakis (2-methylopropyl-isocyanide) copper (i) tetrafluoroborate

כמות:

1 milligram(s)

טופס פרצבטיות:

Kit for radiopharmaceutical preparation

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

technetium (99mTc) sestamibi

מצב אישור:

Marketed

תאריך אישור:

2008-11-21

עלון מידע

08 CON 4376 Ireland PIL 23062021_clean
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 (scin

מאפייני מוצר

Health Products Regulatory Authority
08 September 2021
CRN00C4FK
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Technescan MIBI 1mg 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 the 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