MYOVIEW

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

TETROFOSMIN

Disponibbli minn:

GE Healthcare Limited

Kodiċi ATC:

V09GA02

INN (Isem Internazzjonali):

TETROFOSMIN

Dożaġġ:

230 Microgram

Għamla farmaċewtika:

Kit for radiopharmaceutical preparation

Tip ta 'preskrizzjoni:

Product subject to Restricted Prescription (C)

Żona terapewtika:

technetium (99mTc) tetrofosmin

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2001-08-02

Fuljett ta 'informazzjoni

This radiopharmaceutical will deliver low amounts
of ionising radiation with the least risk of cancer and
hereditary abnormalities.
ALLERGIC REACTIONS
If you have an allergic reaction when you are in hospital
or a clinic having the scan, tell the nuclear medicine
doctor straight away. The signs may include:
•
skin rash or itching or flushing
•
swelling of the face
•
difficulty breathing.
In more serious cases reactions may include:
•
passing out (unconsciousness), feeling dizzy or
lightheaded.
If any of the side effects above happen after you
leave the hospital or clinic, go straight to the casualty
department of your nearest hospital.
OTHER SIDE EFFECTS INCLUDE
•
An uncomfortable feeling of warmth beginning
where the injection was given
•
headache
•
feeling sick (nausea) or being sick (vomiting)
•
changes in taste, such as a metallic taste
•
changes in smell
•
a warm feeling in the mouth
•
increase in the number of white blood cells (seen
when you have some types of blood tests).
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your nuclear medicine
doctor. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly
via the national reporting system
United Kingdom:
The Yellow Card Scheme, at
www.mhra.gov.uk/yellowcard.
ADMINISTRATION OF MYOVIEW AND CONDUCT OF THE
PROCEDURE
FOR A HEART SCAN THE USUAL DOSE IS:
•
One injection after you have rested.
•
A second injection (after at least one hour), when
your heart is working harder than normal. Such as
during or just after exercise.
The order of the two injections may be the opposite way
round for some people. Other people only need one
injection. In some cases your nuclear medicine doctor
may decide that it is best to give the two injections on
separate days.
FOR A BREAST SCAN THE USUAL DOSE IS:
•
One single injection.
IF YOU ARE GIVEN MORE MYOVIEW THAN YOU SHOULD
Myoview is given in a hospital or clinic by a specially
trained and qualified person. It is unlikely that you wil

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MYOVIEW 230 micrograms kit for radiopharmaceutical preparation.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 230 micrograms of tetrofosmin.
Excipients with known effect:
The reconstituted injection contains 0.08-0.16mg/ml sodium
For the full list of excipients, see section 6.1.
Myoview is reconstituted with Sodium Pertechnetate (
99m
Tc) Injection Ph.Eur. (not included in this kit) to prepare
technetium (
99m
Tc) tetrofosmin injection.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
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).
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
POSOLOGY
Paediatric population
Myoview is not recommended for use in children or adolescents as data
are not available for these age groups.
Adults
MYOCARDIAL IMAGING
Patients should be requested to fast overnight or to have only a light
breakfast on the morning of the procedure.
For diagnosis and localization of myocardial ischaemia (using planar
or SPECT techniques) and assessment of left
ventricular function using ECG-gated SPECT, the usual procedure
involves two intravenous injections of tetrofosmin
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