MYOVIEW 230 micrograms kit for radiopharmaceutical preparation lyophilisate for sol for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TETROFOSMIN

Available from:

GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway

ATC code:

V09GA02

INN (International Name):

TETROFOSMIN 230 µg

Pharmaceutical form:

KIT FOR RADIOPHARMACEUTICAL PREPARATION SOLUTION FOR INJECTION

Composition:

TETROFOSMIN 230 µg

Prescription type:

POM

Therapeutic area:

DIAGNOSTIC RADIOPHARMACEUTICALS

Authorization status:

Authorised

Authorization date:

2007-04-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYOVIEW 230 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION,
LYOPHILISATE FOR SOLUTION
FOR INJECTION
Tetrofosmin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN MYOVIEW,
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.
−
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.
IN THIS LEAFLET:
1.
What Myoview is and what it is used for
2.
What you need to know you receive Myoview
3.
How to use Myoview
4.
Possible side effects
5.
How to store Myoview
6.
Contents of the pack and other information
1.
WHAT MYOVIEW IS AND WHAT IT IS USED FOR
This medicine is for diagnostic use only. It is used only to help
identify illness.
Myoview contains the active substance called tetrofosmin. When mixed
with technetium (
99m
Tc) it
becomes a radiopharmaceutical product.
It is injected into a vein by a specially trained and qualified
person.
•
It collects in a specific organ or part of your body.
•
It is seen, from outside your body, by taking a scan (a picture) using
special cameras.
•
Your doctor will explain for which particular part of your body the
scan is required.
•
The scan can help your nuclear medicine doctor find out more about
your condition and decide
on possible treatment.
The scan can be used:
•
to examine blood flow in your heart muscle. After a heart attack, the
blood in your heart muscle
may be flowing at a lower rate. As part of the scan your doctor may
decide to monitor how your
heart is working.
•
to detect and examine a suspected lump in your breast tissue.
Your nuclear medicine doctor will explain which part of your body will
be scanned.
The use of Myoview does involve exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have considered that the clinical benefit that
you will obtain from

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MYOVIEW 230 micrograms kit for radiopharmaceutical preparation
lyophilisate for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 230 micrograms of tetrofosmin.
Excipients with known effect:
The reconstituted injection contains 3.6 – 3.7 sodium.
For a full list of excipients, see section 6.1.
Myoview is reconstituted with sodium pertechnetate (
99m
Tc) injection (not included in this kit) to
prepare technetium (
99m
Tc) tetrofosmin injection.
Sodium pertechnetate (
99m
Tc) injection is produced by a [
99
Mo/
99m
Tc] generator. Technetium (
99m
Tc)
disintegrates with the emission of gamma radiation (energy 141 keV)
and a half-life of 6.02 hours.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation, lyophilisate for solution for
injection
A white powdery solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution with Sodium Pertechnetate (
99m
Tc) Injection the product is indicated in adults for:
MYOCARDIAL IMAGING
Myoview is a myocardial perfusion agent indicated as an adjunct in the
diagnosis and localization of
myocardial ischaemia and/or infarction.
In patients undergoing myocardial perfusion scintigraphy, ECG-gated
SPECT can be used for
assessment of left ventricular function (left ventricular ejection
fraction and wall motion).
2
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lyophilisate for injection, intended for reconstitution with 4-8 ml of
sterile Sodium Pertechnetate
(
99m
Tc) Injection Ph.Eur. at a radioactive concentration not exceeding 1.5
GBq/ml.
POSOLOGY
PAEDIATRIC POPULATION
Myoview is not recommended for use in children or adoles