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MYOVIEW 230 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION.

Active substance(s): TETROFOSMIN

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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 will
be given too much. However, in the case of an overdose,
you will receive the appropriate treatment.
If you have any concerns talk to your nuclear medicine
doctor.
Duration of the procedure
Your nuclear medicine doctor will inform you about the
usual duration of the procedure.
After administration of Myoview, you should:
- urinate frequently in order to eliminate the product
from your body.
The nuclear medicine doctor will inform you if you need
to take any special precautions after receiving this
medicine. Contact the nuclear medicine doctor if your
have any questions.

Document: 1187904 GB/IE Version: 2 Draft: 1

4. Possible side effects
Like all medicines, Myoview can cause side effects,
although not everybody gets them. They are very rare
(affecting less than 1 in 10,000 people).

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.

Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Myoview
You will not have to store this medicine.
This medicine is stored under the responsibility of
the specialist in appropriate premises. Storage of
radiopharmaceuticals will be in accordance with the
national regulations for radioactive materials.
Hospital staff will ensure that the product is stored and
disposed of correctly and not used after the expiry date
stated on the label.
This following information is intended for healthcare or
medical professionals only.
Keep this medicine out of the sight and reach of
children
• Do not use Myoview after the expiry date which is
stated on the label, after EXP.
• Store the product in refrigerator at 2-8°C.
• Chemical and physical in-use stability of the
reconstituted solution for injection has been
demonstrated for 12 hours at 2-8°C. Store the
reconstituted product in a refrigerator (2-8°C)
6. Contents of the pack and other information
This following information is intended for healthcare or
medical professionals only.
What Myoview contains
• The active ingredient is tetrofosmin. Each vial of
Myoview contains 230 micrograms of tetrofosmin.

• The other ingredients
are stannous chloride
dihydrate, disodium
sulphosalicylate,
sodium D-gluconate
and sodium hydrogen
carbonate.
What Myoview looks like
and contents of the pack
Myoview is a kit for
radio-pharmaceutical
preparation, it is supplied
as a single colourless
glass vial containing a
powder for solution for
injection. Pack sizes of
2 or 5 vials are available,
not all pack sizes may be
marketed.
Marketing Authorisation
Holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire
HP7 9NA
United Kingdom
Manufacturer
GE Healthcare AS
Nycoveien 1-2
NO-0401 Oslo
Norway
This leaflet was last
approved in March 2016.

GE Healthcare

PATIENT
INFORMATION

MYOVIEW TM
230 micrograms kit for
radiopharmaceutical
preparation
Tetrofosmin

1 1 8 7 9 0 4

1187904 GB/IE

Marketing
Authorisations
UK: PL 00221/0142
Ireland: PA 240/7/2
Myoview is a trademark
of GE Healthcare.
GE and the GE Monogram
are trademarks of
General Electric
Company.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Myoview 230 micrograms kit for
radiopharmaceutical preparation
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 before you are given
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

Document: 1187904 GB/IE Version: 2 Draft: 1

This medicine is for diagnostic use only. It is used only to
help identify illness.
Myoview is a ‘radio-pharmaceutical’ medicine. It is given
before a scan and helps a special camera see inside a
part of your body.
• It contains an active ingredient called ‘tetrofosmin’.
This is mixed with a radioactive ingredient called
‘technetium 99m’ before it is used.
• Once injected it can be seen from outside your body
by a special camera used in the scan.

• The scan can help your nuclear medicine doctor see
how well the heart is working, or see damage to the
heart after a heart attack.
• Some other people are given this medicine before a
scan to look at lumps in the breast.
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 the procedure with
the radiopharmaceutical outweighs the risk due to
radiation. Ask your nuclear medicine doctor if you have
any questions.
2. What you need to know before you are given
Myoview
Do not use Myoview:
• If you are allergic (hypersensitive) to Myoview or any
other ingredient (listed in Section 6).
• If you are pregnant or think you might be pregnant.
Do not take Myoview if any of the above applies to you.
If you are not sure talk to your nuclear medicine doctor.
Warnings and Precautions
Talk to your nuclear medicine doctor before using
Myoview:
• If the person who will be given this medicine is a
child or adolescent.
• If you have missed your last period. This may
indicate that you are pregnant and therefore unable
to be given Myoview (see section Pregnancy and
breast-feeding).
• If you are on a low sodium diet.
• If you are breast-feeding.
Before administration of Myoview you should:
Drink plenty of water before the start of the
examination in order to urinate as often as possible
during the first hours after the scan.

Children and adolescents
Efficacy and safety in patients below 18 years has not
been established.
Other medicines and Myoview
Please tell your nuclear medicine doctor, who will
supervise the procedure, if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. This includes herbal
medicines. This is because some medicines can affect
the way Myoview works.
If you are having a heart scan tell your nuclear medicine
doctor if you are taking any of the types of medicine
below. This is because they may affect the results of
your scan:
• Beta blockers such as atenolol, bisoprolol or
propranolol.
• Calcium channel blockers such as nifedipine,
diltiazem or felodipine.
• Nitrates such as glyceryl trinitrate, isosorbide
mononitrate or isosorbide dinitrate.
• Any medicines for your blood pressure, your heart or
heart failure.
If you are not sure if any of the above applies to you,
talk to your nuclear medicine doctor before having
Myoview.
Having Myoview with food and drink
If you are having:
• A heart scan - you may be asked not to eat the night
before. Or you may be asked to have only a light
breakfast on the morning of the scan.
• A breast scan - you can eat and drink liquids
normally.
Pregnancy and breast-feeding
You should not be given Myoview if you are pregnant
or think you may be pregnant. This is because it may
affect the baby.
Do not breast-feed if you are given Myoview. This is
because small amounts of ‘radioactivity’ may pass

into the mother’s milk. If you are breast-feeding, your
nuclear medicine doctor may wait until you have
finished breast-feeding before using Myoview. If it is not
possible to wait, your nuclear medicine doctor will ask
you to:
• stop breast-feeding for 12 hours or longer, and
• use formula feed for your child, and
• express (remove) breast milk and throw away the
milk.
Your nuclear medicine doctor will let you know when
you can start breast-feeding again.
Driving and using machines
It is considered unlikely that Myoview will affect your
ability to drive or to use machines. Ask your nuclear
medicine doctor if you can drive or use machines after
you have been given Myoview.
Important information about Myoview
Myoview contains 0.65 mg sodium per vial. This needs
to be considered for people on a low sodium diet.
When Myoview is used you are exposed to radioactivity.
• Your nuclear medicine doctor will always consider the
possible risks and benefits before you are given the
medicine.
Ask your nuclear medicine doctor if you have any
questions.
3. How to use Myoview
There are strict laws on the use, handling and disposal
of radiopharmaceutical products.
Myoview will be given to you by a specially trained and
qualified person.
• Myoview will always be used in a hospital or clinic.
• They will tell you anything you need to know for its
safe use.
The dose you are given depends on the type of scan you
are having. Your nuclear medicine doctor will decide on
the dose that is best for you. It will be the smallest dose
necessary to get the desired information.

Document: 1187905 GB/IE Version: 0

in rabbits, but only at cumulative doses exceeding 10,000 times the maximum human
single dose. In rats receiving these doses there was no significant evidence of toxicity.
Studies on reproductive toxicity have not been conducted. Tetrofosmin showed no
evidence of mutagenic potential in vitro or in vivo mutagenicity studies. Studies to assess
the carcinogenic potential of Myoview have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Stannous chloride dihydrate
Disodium sulphosalicylate
Sodium D-gluconate
Sodium hydrogen carbonate
Nitrogen gas
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with
other medicinal products except those mentioned in section 12.
6.3 Shelf life
The shelf-life of the packaged product is 35 weeks.
Chemical and physical in-use stability of the reconstituted solution for injection has been
demonstrated for 12 hours at 2°C-8°C.
Store the reconstituted product in a refrigerator (2°C-8°C).
6.4 Special precautions for storage
Store in a refrigerator (2°C-8°C).
For storage conditions of the reconstituted medicinal product, see section 6.3.
Storage should be in accordance with national regulations for radioactive materials.
6.5 Nature and contents of container
The product is supplied in a 10 ml clear glass vial sealed with a chlorobutyl rubber closure
and flip off overseal.
Pack sizes: 2 or 5 vials.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
The reconstituted product is a clear colourless solution.
General warning
Radiopharmaceuticals should be received, used and administered only by authorised
persons in designated clinical settings. Its receipt, storage, use, transfer and disposal
are subject to the regulations and/or appropriate licences of the competent official
organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation
safety and pharmaceutical quality requirements. Appropriate aseptic precautions should
be taken.
Contents of the vial are intended only for use in the preparation of technetium (99mTc)
tetrofosmin injection and are not to be administered directly to the patient without first
undergoing the preparative procedure.
For instructions on reconstitution of the medicinal product before administration,
see section 12.
If at any time in the preparation of this product the integrity of this vial is compromised it
should not be used.
Administration procedures should be carried out in a way to minimise risk of contamination
of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.
The content of the kit before reconstitution is not radioactive. However, after sodium
pertechnetate (99mTc), Ph. Eur. is added, adequate shielding of the final preparation must
be maintained.
The administration of radiopharmaceuticals creates risks for other persons from
external radiation or contamination from spill of urine, vomiting etc. Radiation protection
precautions in accordance with national regulations must therefore be taken.

After use, all materials associated with the preparation and administration of
radiopharmaceuticals, including any unused product and its container, should be
decontaminated or treated as radioactive waste and disposed of in accordance with the
conditions specified by the local competent authority. Contaminated material must be
disposed of as radioactive waste via authorised route.
7 MARKETING AUTHORISATION HOLDER
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
UK: PL 00221/0142
Ireland: PA 240/7/2
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 02 August 2001
Date of last renewal: January 2010
10 DATE OF REVISION OF THE TEXT
March 2016
11 DOSIMETRY
Technetium (99mTc) is produced by means of a (99Mo/99mTc) generator and decays with the
emission of gamma radiation with a mean energy of 140keV and a half life of 6.02 hours
to technetium (99Tc) which, in view of its long half life of 2.13 x 105 years can be regarded
as quasi stable.
The estimated absorbed radiation doses to an average adult patient (70kg) from
intravenous injections of tetrofosmin (99mTc) are listed below. The values are calculated
assuming urinary bladder emptying at 3.5 hour intervals.
Frequent bladder emptying should be encouraged after dosing to minimize radiation
exposure.
Absorbed dose per unit of
activity administered (mGy/MBq)
Organ
Heart Wall
Breasts

Exercise
4.1E-03
2.2E-03

Rest
4.0E-03
1.8E-03

Gallbladder wall
Upper large intestine
Lower large intestine
Urinary bladder wall
Small intestine
Kidney
Salivary glands
Ovaries
Uterus
Bone surface
Thyroid
Pancreas
Stomach
Adrenals
Red Marrow
Spleen
Muscle
Testes
Liver
Thymus
Brain
Lungs
Skin
Effective Dose
(mSv/MBq)

3.3E-02
2.0E-02
1.5E-02
1.6E-02
1.2E-02
1.0E-02
8.0E-03
7.9E-03
7.3E-03
6.2E-03
4.3E-03
5.0E-03
4.6E-03
4.3E-03
4.1E-03
4.1E-03
3.5E-03
3.4E-03
3.2E-03
3.1E-03
2.7E-03
2.3E-03
2.2E-03

4.9E-02
3.0E-02
2.2E-02
1.9E-02
1.7E-02
1.3E-02
1.2E-02
9.6E-03
8.4E-03
5.6E-03
5.8E-03
5.0E-03
4.6E-03
4.1E-03
4.0E-03
3.8E-03
3.3E-03
3.1E-03
4.2E-03
2.5E-03
2.2E-03
2.1E-03
1.9E-03

6.0 E-03

7.2 E-03

99m

Tc-tetrofosmin is administered as two intravenous injections either rest first and stress
second or stress first and rest second. The recommended activity range for the first dose
is 250-400 MBq; the recommended activity range for the second dose given at least 1 hour
later, is 600-800 MBq.
The effective dose after administration of 800 MBq at rest or in breast imaging is 5.7 mSv
(per 70 kg adult patient).
The absorbed radiation dose for the resting subject in the heart is 4.0E-03 mGy/MBq and
after exercise is 4.1E-03 mGy/MBq. In the breast the absorbed radiation dose in breast
imaging is 1.8E-03 mGy/MBq. The absorbed radiation dose in the bladder (3.5 hour voiding)
is 1.6E-02 mGy/MBq after exercise and is 1.9E-02 mGy/MBq at rest or in breast imaging.
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Withdrawals should be performed under aseptic conditions. The vials must not be opened
before disinfecting the stopper, the solution should be withdrawn via the stopper using a
single dose syringe fitted with suitable protective shielding and a disposable sterile needle
or using an authorised automated application system.
If the integrity of this vial is compromised, the product should not be used
Method of preparation
Use aseptic technique throughout.
(1) Place the vial in a suitable shielding container and sanitize the rubber septum with the
swab provided.
(2) Insert a sterile needle (the venting needle, see Note a) through the rubber septum.
Using a shielded, 10 ml sterile syringe, inject the required activity of Sodium
Pertechnetate (99mTc) Injection Ph.Eur. (appropriately diluted with 0.9% Sodium
Chloride Injection BP) into the shielded vial (see Notes b to d). Before removing the
syringe from the vial, withdraw 5 ml of gas from above the solution (see Note e).
Remove the venting needle. Shake the vial to ensure complete dissolution of the
powder.
(3) Incubate at room temperature for 15 minutes.
(4) During this time assay the total activity, complete the user label provided and attach
it to the vial.
(5) Store the reconstituted injection at 2-8°C and use within 12 hours of preparation.
Dispose of any unused material and its container via an authorised route.
Notes:
(a) A needle of size 19G to 26G may be used.
(b) The Sodium Pertechnetate (99mTc) Injection Ph.Eur. used for reconstitution should
contain less than 5ppm aluminium.
(c) The volume of diluted Sodium Pertechnetate (99mTc) Injection Ph.Eur. added to the vial
must be in the range 4-8 ml.
(d) The radioactive concentration of the diluted Sodium Pertechnetate (99mTc) Injection
Ph.Eur. must not exceed 1.5 GBq/ml when it is added to the vial.
(e) For preparation volumes of more than 6 ml, the remaining vial headspace is less than
the 5 ml added air volume. In these cases, the withdrawal of a 5 ml volume of gas
ensures that all of the vial headspace is replaced by air.
(f) The pH of the prepared injection is in the range 7.5-9.0.
Quality control
Equipment and eluent
(1) Glass Microfiber Chromatography Paper impregnated with Silicic Acid (GMCP-SA)
TLC strip (2cm x 20cm) – Do not heat activate
(2) Ascending chromatography tank and cover
(3) 65:35% v/v acetone : dichloromethane mixture (prepared fresh daily)
(4) 1ml syringe with 22-25G needle
(5) Suitable counting equipment
Method
(1) Pour the 65:35% v/v acetone:dichloromethane mixture into the chromatography tank
to a depth of 1cm and cover the tank to allow the solvent vapour to equilibrate.
(2) Mark a Glass Microfiber Chromatography Paper impregnated with Silicic Acid
(GMCP-SA) TLC strip with a pencil line at 3cm from the bottom and, using an ink
marker pen, at 15cm from the pencil line. The pencil line indicates the origin where
the sample is to be applied and movement of colour from the ink line will indicate the
position of the solvent front when upward elution should be stopped.

(3) Cutting positions at 3.75cm and
12cm above the origin (Rf’s 0.25
and 0.8 respectively) should also be
marked in pencil.
(4) Using a 1ml syringe and needle, apply a
10μl sample of the prepared injection at
the origin of the strip. Do not allow the
applied sample to come into contact
with the pencil mark. Do not allow
the spot to dry. Place the strip in the
chromatography tank immediately and
replace the cover. Ensure that the strip
is not adhering to the walls of the tank.
Note: A 10μl sample will produce a spot
with a diameter of approximately 10mm.
Different sample volumes have been
shown to give unreliable radiochemical
purity values.
(5) When the solvent reaches the ink
line, remove the strip from the tank
and allow it to dry.
(6) Cut the strip into 3 pieces at the
marked cutting positions and
measure the activity on each using
suitable counting equipment. Try to
ensure similar counting geometry for
each piece and minimize equipment
dead time losses.
(7) Calculate the radiochemical purity
from:% tetrofosmin (99mTc)
= Activity of centre piece x 100
Total activity of all 3 pieces
Note: Free (99mTc) pertechnetate runs to
the top piece of the strip. Tetrofosmin
(99mTc) runs to the centre piece of the
strip. Reduced hydrolysed-99mTc and any
hydrophilic complex impurities remain at
the origin in the bottom piece of the strip.
Do not use material if the radiochemical
purity is less than 90%.
13 FURTHER INFORMATION
Manufacturers
GE Healthcare AS
Oslo Plant
Nycoveien 1-2
0401 Oslo
Norway
Myoview is a trademark of
GE Healthcare.
GE and the GE Monogram are trademarks
of General Electric Company.

GE Healthcare
HEALTHCARE PROFESSIONAL
INFORMATION

MYOVIEW

TM

230 micrograms kit for
radiopharmaceutical
preparation
Tetrofosmin

1187905

1187905 GB/IE

Document: 1187905 GB/IE Version: 0

PACKAGE LEAFLET: INFORMATION FOR HEALTHCARE PROFESSIONAL
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 0.08-0.16 mg/ml sodium.
For a full list of excipients, see section 6.1.
Myoview is reconstituted with Sodium Pertechnetate (99mTc) Injection Ph.Eur. (not included
in this kit) to prepare technetium (99mTc) 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 (99mTc) 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 (99mTc), one given at peak stress and one
given at rest. The order of the two administrations can be either rest first and stress second
or stress first and rest second.
When rest and stress injections are administered on the same day, the activity administered
for the second dose should result in a myocardial count rate at least three times greater
than that of the residual activity from the first dose. The recommended activity range
for the first dose is 250-400 MBq; the recommended activity range for the second dose
given at least 1 hour later, is 600-800 MBq. For studies employing ECG-gated SPECT, use of
activities at the higher end of these ranges is warranted.
When rest and stress injections are administered on different days, the recommended
activity range for each dose of tetrofosmin (99mTc) is 400-600 MBq. For studies on larger
individuals (e.g. those with abdominal obesity or women with large breasts) and for those
employing ECG-gated SPECT, use of activities at the higher end of this range is warranted.

The total activity administered for stress and rest myocardial imaging studies, whether
performed on one or two days, should be restricted to 1200 MBq.
Based upon clinical trial data a minimum activity of 550 MBq has been shown to be
adequate for ECG-gated SPECT. The activity administered for ECG-gated SPECT myocardial
imaging should adhere to the guidelines specified in the previous paragraphs.
As an adjunct in the diagnosis and localization of myocardial infarction, one injection of
tetrofosmin (99mTc) (250-400 MBq) at rest is sufficient.
Planar or preferably SPECT imaging should begin no earlier than 15 minutes post-injection.
There is no evidence for significant changes in myocardial concentration or redistribution
of tetrofosmin (99mTc). Therefore, images may be acquired up to at least four hours
postinjection.
For planar imaging the standard views (anterior, LAO 40º-45º, LAO 65º-70º and/or left lateral)
should be acquired.
Breast Imaging
For the diagnosis and localization of suspected breast lesions, the recommended
procedure involves a single intravenous injection of tetrofosmin (99mTc) between
500– 750 MBq. The injection should preferably be given in a foot vein or a site other than
the arm on the side of the suspected breast lesion. The patient does not need to fast
before the injection.
Breast imaging optimally initiated 5 – 10 minutes post injection with the patient in the
prone position with the breast(s) freely pendant. A special imaging couch designed for
nuclear medicine breast imaging is recommended. A lateral image of the breast suspected
of containing lesions should be obtained with the camera face as close to the breast as
is practicable.
The patient should then be repositioned so that a lateral image of the pendant
contralateral breast can be obtained. An anterior supine image may then be obtained with
the patient’s arms behind her head.
Method of administration
This medicinal product should be reconstituted before administration to the patient.
For instructions on reconstitution of the medicinal product before administration,
see section 12.
For patient preparation, see section 4.4
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Must not be given during pregnancy (see section 4.6).
4.4 Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions
The possibility of hypersensitivity including anaphylactic/anaphylactoid reactions should
always be considered. Advanced life support facilities should be readily available.
Paediatric population
Paediatric population, see section 4.2.
Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely benefit.
The activity administered should in every case be as low as reasonably achievable to
obtain the required diagnostic information.
Renal impairment and hepatic impairment
Careful consideration of the benefit risk ratio in these patients is required since an
increased radiation exposure is possible.
Patient preparation
The patient should be well hydrated before the start of the examination and urged to
void as often as possible during the first hours after the examination in order to reduce
radiation.
Breast lesions less than 1 cm in diameter may not all be detected with scintimammography
as the sensitivity of Myoview for the detection of these lesions is 36% (n=5 of 14,95% CI 13%
to 65%) relative to histological diagnosis. A negative examination does not exclude breast
cancer especially in such a small lesion.

Efficacy in the identification of axillary lesions has not been proven, consequently
scintimammography is not indicated for staging breast cancer.
In myocardial scintigraphy investigations under stress conditions, the contraindications
associated with the induction of stress should be considered.
Precautions with respect to environmental hazard see section 6.6
Specific warnings
This medicinal product contains 0.08-0.16mg/ml sodium. This needs to be taken into
consideration for patients on a controlled sodium diet.
4.5 Interaction with other medicinal products and other forms of interaction
No formal studies on the interaction of Myoview with other drugs have been performed.
However, no interactions were reported in clinical studies in which Myoview was
administered to patients receiving comedication. Drugs which influence myocardial
function and/or blood flow, e.g. beta blockers, calcium antagonists or nitrates, can lead
to false negative results in diagnosis of coronary artery disease. The results of imaging
studies should always, therefore, be considered in the light of current medication.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential
When it is necessary to administer radioactive medicinal products to women of
childbearing potential, information should always be sought about pregnancy. Any woman
who has missed a period should be assumed to be pregnant until proven otherwise.
Where uncertainty exists it is important that radiation exposure should be the minimum
consistent with achieving the desired clinical information. Alternative techniques which do
not involve ionising radiation should be considered.
Pregnant women
Myoview is contraindicated in pregnancy (see section 4.3). Animal reproductive toxicity
studies havenot been performed with this product. Radionuclide procedures carried out
on pregnant women also involve radiation doses to the foetus. Administration of 250 MBq
tetrofosmin (99mTc) at exercise, followed by 750 MBq at rest results in an absorbed dose to
the uterus of 8.1 mGy. A radiation dose above 0.5 mGy (equivalent to the exposure from
annual background radiation) would be regarded as a potential risk to the foetus.
Breast feeding
Before administering radioapharmaceuticals to a mother who is breast feeding,
consideration should be given as to the possibility of delaying the administration of
a radionuclide until the mother has ceased breast feeding and to what is the most
appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in
breast milk. It is not known whether tetrofosmin (99mTc) is secreted in human milk, therefore
if administration is considered necessary, formula feeding should be substituted for breast
feeding for at least 12 hours.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
The frequencies of the undesirable effects are defined as follows:
Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100),
Rare (≥1/10,000 to <1/1,000), Very Rare (<1/10,000) and not known (cannot be determined
with the data available).
Adverse drug reactions following administration of tetrofosmin (99mTc) are very rare
(less than 1 in 10,000).
The following undesirable effects are recognised for Myoview:
Immune system disorders
Face oedema, hypersensitivity reaction, allergic reaction, anaphylactic reaction
Nervous system disorders
Headache, dizziness, taste metallic, disturbances of smell and taste
Vascular disorders
Flushing, hypotension
Respiratory, thoracic and mediastinal disorders
Dyspnoea
Gastrointestinal disorders
Vomiting, nausea, burning mouth

Skin and subcutaneous tissue disorder
Urticaria, itching, erythematous rash
General disorders and administration site condition
Feeling of warmth
Investigations
White blood cell count increased
Some reactions were delayed by several hours following administration of tetrofosmin (99mTc).
Isolated cases of serious reactions have been reported, including anaphylactic reaction
(less than 1 in 100,000) and severe allergic reaction (single report).
Since the administered substance quantity is very low, the major risk is caused by the
radiation. Exposure to ionising radiation is linked with cancer induction and a potential for
developing hereditary defects.
As the effective dose is 8.5 mSv when the maximal recommended activity of 1200 MBq is
administered these adverse reactions are expected to occur with a low probability.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at website www.mhra.gov.uk/yellowcard.
4.9 Overdose
In cases of overdosage of radioactivity frequent micturition and defaecation should be
encouraged in order to minimize radiation dosage to the patient.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, cardiovascular system,
technetium (99mTc) tetrofosmin, ATC Code: V09GA02.
Pharmacological effects are not expected following intravenous administration of
reconstituted Myoview at the recommended dosage. Studies in animals have shown that
myocardial uptake of tetrofosmin (99mTc) is linearly related to coronary blood flow, confirming
the effectiveness of the complex as a myocardial perfusion imaging agent.
Based upon clinical experience with ECG-gated myocardial perfusion scintigraphy, this
method can be used to monitor for changes (or stability) in left ventricular function
over time. Reliability of such serial assessment is expected to be similar to that of other
commonly used measurement techniques (e.g. ECG-gated blood-pool scintigraphy).
Limited data in animals show uptake of tetrofosmin (99mTc) into breast tumour cells.
5.2 Pharmacokinetic properties
Organ uptake
Myocardial uptake: Uptake in the myocardium is rapid, reaching a maximum of about
1.2% of injected dose with sufficient retention to allow imaging of the myocardium by
planar or SPECT techniques from 15 minutes up to 4 hours post-administration.
Elimination
Tetrofosmin (99mTc) is rapidly cleared from the blood after intravenous injection; less than
5% of the administered activity remains in whole blood at 10 minutes post-injection.
Background tissue clearance is rapid from lung and liver and activity is reduced in these
organs following exercise, with enhanced sequestration in skeletal muscle. Approximately
66% of the injected activity is excreted within 48 hours post-injection, with approximately
40% excreted in the urine and 26% in the faeces.
Half-life
Sodium Pertechnetate (99mTc) Injection Ph.Eur. is produced by a [99Mo/99mTc] generator.
Technetium (99mTc) disintegrates with the emission of gamma radiation (energy 141 keV)
and a half-life of 6.02 hours.
Renal/hepatic impairment
The pharmacokinetics in patients with renal or hepatic impairment has not been
characterised.
5.3 Preclinical safety data
Acute toxicity studies employing Myoview at dosage levels of approximately 1050 times
the maximum human single dose failed to reveal mortality or any significant signs of
toxicity in rats or rabbits. In repeated dose studies some evidence of toxicity was observed

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Source: Medicines and Healthcare Products Regulatory Agency

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