230 micrograms Preparation kit for radioactive drugs
tetrofosmin
What Myoview is and what it is used for
This medicine is for diagnostic purposes only, as an aid in disease diagnosis. Myoview is a radioactive medicine. It is given before the examination and allows a special camera to see inside a part of your body.
- The active substance is tetrofosmin. A radioactive substance called technetium-99m is added before the preparation is ready for use.
- Once the preparation has been injected, it can be followed from the outside, with the help of photography with a special camera.
- The pictures can be helpful for your doctor to see how well your heart is working or to see damage to the heart after a heart attack.
- Some people get Myoview before taking a picture when looking for breast tumors.
Your doctor who is responsible for the examination will tell you which part of your body is to be examined.
The use of Myoview involves exposure to small amounts of radioactivity. Your doctor and the doctor responsible for the examination have assessed that the benefits of the radioactive medicine outweigh the risks of the radiation. If you have any further questions, ask your doctor.
What you need to know before using Myoview
Do not use Myoview
- If you are allergic to technetium-99m-tetrophosmin or any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant or think you may be pregnant.
Myoview should not be used in any of the above applies to you. If you are not sure, talk to your doctor.
Warnings and cautions
Talk to your doctor who is responsible for the examination before giving Myoview:
- If the person receiving the medicine is a child or teenager.
- If your last period has not been missed. This may mean that you are pregnant and therefore should not be given Myoview (see section Pregnancy and breast-feeding).
- If you have been prescribed a low-salt diet.
- If you are breast-feeding.
Before using Myoview
You should drink plenty of water before the test to be able to urinate as often as possible during the first hours after the test.
Children and young people
Efficacy and safety in patients under 18 years of age have not been established.
Other medicines and Myoview
Tell your doctor who will monitor your examination if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This also applies to herbal medicines. You should do this because some medicines may affect the way Myoview works.
When examining (imaging) the heart, tell your doctor if you are taking any of the following medicines. They may affect the survey results:
- 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 .
- All blood pressure medications, heart medications and medications for heart failure .
If you are not sure if any of the above applies to you, talk to your doctor before taking Myoview.
Myoview with food and drink
- When examining the heart – you may be asked not to eat the night before the examination. Or you can be asked to eat only a light breakfast on the morning of the examination day.
- When examining the breasts – you can eat and drink as usual.
Pregnancy and breastfeeding
You should not be given Myoview if you are pregnant or if it can not be ruled out that you are pregnant as there is a risk that the fetus may be affected.
You should not breastfeed if you are given Myoview as small amounts of radioactivity may pass into your breast milk. If you are breastfeeding, your doctor may wait until breastfeeding has stopped before using Myoview. If it is not possible to wait, your doctor may ask you to:
- stop breastfeeding for 12 hours or longer
- give your baby breast milk substitute, and
- pump out the breast milk and discard it.
Your doctor will tell you when you can start breastfeeding again.
Driving and using machines
Myoview is unlikely to affect your ability to drive or use machines. Ask your doctor if you can drive or use machines after receiving Myoview.
Myoview contains sodium
This medicine contains 15 – 29 mg of sodium (the main ingredient in table salt) per reconstituted bottle. This corresponds to 0.7 – 1.4% of the recommended maximum daily intake of sodium for an adult.
When you receive Myoview, you are exposed to radioactivity.
- Your doctor should always weigh the risks against the expected clinical benefit before receiving the medicine.
If you have any further questions, ask your doctor
How to use Myoview
There are strict rules regarding the use, handling, and disposal of radioactive drugs. You will receive Myoview as an injection by specially trained and qualified personnel.
- Myoview is always given in appropriate hospital facilities.
- The staff will inform you about everything you need to know for safe use.
Dose one is determined based on which examination you will undergo. Your doctor in charge of the examination will decide which dose is best for you. It will be the lowest possible dose one to provide the desired information.
Use of Myoview and how the survey is conducted
When examining the heart, the dose is:
- An injection after resting
- A second injection (after at least an hour) when your heart is pumping faster than normal, as it does during or shortly after physically demanding activity
Some people can get the two injections in reverse order. Others only need a single injection. It may also be that your doctor in charge decides that it is better to give the two injections on different days.
When examining the breasts, the dose is:
- A single injection
If you take more Myoview than you should
Myoview is only given in hospitals and by specially trained and authorized staff. It is unlikely that you will be given too large a dose. If you have any concerns, talk to your doctor who is responsible for the examination.
Duration of the survey
Your doctor in charge of the examination will inform you about how long the examination usually takes.
After using Myoview you should:
- Urinate frequently to excrete the drug from the body.
The doctor in charge will tell you if you need to take any special precautions after receiving this medicine. If you have any further questions, ask your doctor.
Possible side effects
Like all medicines, Myoview can cause side effects, although not everybody gets them.
This radioactive drug emits small amounts of ionizing radiation which is linked to the lowest risk of cancer and genetic mutations.
Allergic reactions
If you get an allergic reaction when you are examined at the hospital, tell your doctor immediately. Signs of an allergic reaction can be:
- skin rash, itching or redness
- facial swelling
- difficulty breathing
In more severe reactions, the following may also occur:
- fainting (unconsciousness), dizziness or dizziness
If any of the above side effects occur while you are leaving the hospital, contact the emergency department at your nearest hospital immediately.
Other side effects are
- unpleasant heat sensation at the injection site
- headache
- nausea or vomiting
- altered sense of taste such as metallic taste
- altered sense of smell
- feeling of warmth in the mouth
- increased number of white blood cells (can be seen in certain types of blood tests).
How to store Myoview
You will not need to store this medicine. The specialist doctor is responsible for keeping it in a suitable place. Radioactive medicines must be stored by national laws that apply to radioactive materials.
The staff at the hospital is responsible for ensuring that the product is stored and disposed of correctly and is not used after the specified expiry date.
The following information is intended for healthcare professionals only.
Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the label, after EXP.
- Store in a refrigerator at 2-8 ° C. Store in the original package. Sensitive to light.
- Chemical and physical in-use stability of the reconstituted solution for injection has been demonstrated for 12 hours at 2-25 ° C. Store the reconstituted product at a maximum of 25 ° C. Do not freeze.
Contents of the pack and other information
Content declaration
The following information is intended for healthcare professionals only.
Content declaration
- The active substance is tetrofosmin. One bottle of Myoview contains 230 micrograms of tetrofosmin.
- Excipients: tin chloride dihydrate, sodium sulfosalicylate, sodium D-gluconate and sodium bicarbonate.
What the medicine looks like and contents of the pack
Myoview is a kit for the preparation of radioactive drugs. It is supplied in a clear glass bottle, which contains a powder for solution for injection.
Pack sizes: 2 or 5 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder
GE Healthcare AS
POBox 4220 Nydalen
NO-0401 Oslo
Norway
Manufacturer
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway