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Myoview Powder for solution for injection


MYOVIEW™

For preparation of Technetium [99mTc] Tetrofosmin Injection


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about MYOVIEW. It does not contain all the available information, nor does it take the place of talking to your doctor or pharmacist.

All medicines and diagnostic preparations have risks and benefits. Your doctor has weighed the risks of you being treated with MYOVIEW against the expected benefits.

If you have any concerns about being given this medicine, ask your doctor or pharmacist or treatment provider.

Keep this leaflet. You may need to read it again.

What MYOVIEW is used for

MYOVIEW is used in the preparation of Technetium [99mTc] Tetrofosmin Injection, a radioactive medicinal product. Such substances are also known as radiopharmaceuticals.

Such radiopharmaceuticals are given in small amounts to find or rule out a disease. When used in this way the radiation your body receives is very low and is considered safe.

After the radioactive liquid is given to you, it is taken up by the organs of interest, especially the heart muscle or just passes through your body. The radiation is taken up by a special camera and pictures are prepared. These pictures allow the nuclear medicine doctor to detect any problems.

MYOVIEW is used to help detect areas in the heart that may not be getting enough blood to work properly.

MYOVIEW is used as an aid in diagnosis only. It is not used to treat or cure the condition.

Before you are given MYOVIEW

When you must not be given it

MYOVIEW is not recommended for adolescents or children under 12 years of age.

You must not be given MYOVIEW if you are allergic to it or any of the ingredients listed at the end of this leaflet or have had an allergic reaction in a diagnostic procedure with the same or a similar preparation.

You must not be given MYOVIEW if you are pregnant.

Before you are given it

Your doctor must know about all of the following before you are given MYOVIEW. Tell your doctor if you:

  1. are breastfeeding
    MYOVIEW may be excreted in the breast milk. Therefore, you should stop breastfeeding and substitute formula feeds for at least 24 hours after you are given MYOVIEW.
  2. are taking any medicines that affect your heart or blood pressure, such as
  • beta blockers
  • calcium antagonists
  • vasodilators like tablets or spray containing nitrates
    These medicines can affect the results of the diagnostic tests, so you should mention these to your doctor.
  1. if you are taking any other medicines, including any that you have bought from your pharmacy, supermarket or health food shop.
    Some medicines may affect the way other medicines work. Some can have an unfavourable influence on the diagnostic tests.
  2. if you have allergies to:
  • any other medicines
  • any other substances such as foods, substances to maintain food quality or freshness (preservatives) or colourants (dyes)
  • any of the ingredients of MYOVIEW listed at the end of this .

If you have not told your doctor about any of the above, tell them before you are given any MYOVIEW.

How MYOVIEW is given

Your doctor may have special instructions for you to follow to get ready for your procedure. You should not eat the night before or have only a light breakfast on the morning of your test.

MYOVIEW is given as an injection into a vein. MYOVIEW must only be given by a doctor or nurse.

Your doctor will decide what dose of MYOVIEW you will receive.

MYOVIEW is usually given in two doses, one during exercise (or after you have got medicine to increase your heart rate) and one at rest about 4 hours after the first dose. Soon after it is given diagnostic images will be taken.

If you have any questions about taking MYOVIEW or about the diagnostic procedure, ask your doctor.

After being given MYOVIEW

MYOVIEW breaks down quickly after it is given and is largely removed from the body after about 48 hours.

There are usually no special precautions to observe for radiopharmaceuticals like MYOVIEW because they are used in small amounts for diagnosis.

If you have any questions or concerns, be sure to discuss these with your doctor or pharmacist.

Side Effects

The following rare side effects have been reported after use of MYOVIEW:

  • feeling warm
  • symptoms of allergy/hypersensitivity
  • headache
  • shortness of breath
  • low blood pressure
  • swelling of the face
  • dizziness
  • hot flushes
  • itchy or red rash
  • vomiting
  • metallic taste in the mouth
  • disturbance in sense of smell
  • mild burning sensation in the mouth

Occasionally other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of side effects. You may not experience any of them.

Overdose

The dose of MYOVIEW you will receive is calculated by a qualified nuclear medicine doctor and given to you in a highly specialised setting by either the doctor or nuclear medicine technologist. Therefore the possibility of overdose is minimal.

Storage

MYOVIEW will be stored by the hospital or clinic.

The hospital or clinic will make sure that MYOVIEW is not used if the expiry date (EXP) printed on the pack has passed.

Further information

This is not all the information that is available on MYOVIEW. If you have any more questions or are not sure about anything, ask your doctor or treatment provider.

Product description

Ingredients

Each vial contains:

active ingredient –
tetrofosmin 0.23mg

other ingredients –

  • stannous chloride dihydrate
  • sodium bicarbonate
  • sodium gluconate
  • disodium sulfosalicylate
  • nitrogen gas in the headspace

Australian Registration Number: AUST R 60998

Sponsor

MYOVIEW is supplied in Australia by:
GE Healthcare Australia Pty Ltd
ABN 32 001 408 402
32 Phillip St
Parramatta NSW 2150
PO Box 5079
Parramatta NSW 2150
Tel: 1300 88 77 64
Fax: 1300 434 232

This leaflet was prepared in October 2014.

Myoview is a trademark of GE Healthcare.

GE and the GE Monogram are trademarks of General Electric Company.

Published by MIMS October 2015