STAMICIS 1mg kit for radiopharmaceutical preparation

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate

Available from:

CIS bio International

ATC code:

V09GA; V09GA01

INN (International Name):

Tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate

Dosage:

1 milligram(s)

Pharmaceutical form:

Kit for radiopharmaceutical preparation

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

Technetium (99mTc) compounds; technetium (99mTc) sestamibi

Authorization status:

Marketed

Authorization date:

2008-12-12

Patient Information leaflet

1
T3069p_IE
12/2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STAMICIS 1 MG
KIT FOR RADIOPHARMACEUTICAL PREPARATION
[Tetrakis (2-methoxyisobutyl isonitrile) 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 STAMICIS
is and what it is used for
2.
What you need to know before STAMICIS is used
3.
How STAMICIS is used
4.
Possible side effects
5.
How STAMICIS is stored
6.
Contents of the pack and other information
1.
WHAT STAMICIS IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical product for diagnostic use
only.
STAMICIS contains a substance called [Tetrakis (2-methoxyisobutyl
isonitrile) 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). STAMICIS is also used in the
diagnosis of breast abnormalities in addition to other diagnostic
methods when the results are unclear.
STAMICIS can also be used to find the position of overactive
parathyroid glands (glands that secrete the
hormone that controls blood calcium levels).
After STAMICIS 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. You nuclear medicine doctor will then take an image
(scintigraphy) of the concerned organ
which can give your doctor valuable information about the structure
an

Summary of Product characteristics

Health Products Regulatory Authority
20 December 2023
CRN00DPTQ
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
STAMICIS 1mg kit for radiopharmaceutical preparation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg [tetrakis (2-methoxyisobutyl isonitrile)
copper (I)] tetrafluoroborate.
The radionuclide is not part of the kit.
Excipients with known effect:
One ml of solution contains 4.5 mg of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
White powder.
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
secondaryhyperparathyroidism, and in patients with primary
hyperparathyroidismscheduled 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 activity range for intravenous administration to
an adult patient of average weight (70 kg) is for:
_Diagnosis of reduced