Is Myoview injection safe?
Safety and effectiveness of Myoview Injection were established using investigational material shown to have a radiochemical purity of at least 90% prior to administration to patients in clinical studies. The contents of the Myoview vial are not radioactive.
How is Myoview supplied?
How is Myoview Supplied. The kit comprises five vials containing a sterile, non-pyrogenic, freeze dried mixture of tetrofosmin, stannous chloride dihydrate, disodium sulphosalicylate, sodium D-Gluconate and sodium hydrogen carbonate, together with appropriate number of radiation labels, and a package insert.
What is a Myoview test?
Myoview. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease;
Can I use Myoview If I am pregnant or breastfeeding?
Animal reproduction studies have not been conducted with Myoview. It is not known whether Myoview can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Therefore, Myoview should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.
Is myoview radioactive?
Radiation Safety - Drug Handling Technetium Tc99m tetrofosmin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [see WARNINGS AND PRECAUTIONS).
What is myoview injection?
MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin. for injection. Technetium Tc99m tetrofosmin injection is a radioactive. diagnostic agent indicated for the following: • Myocardial perfusion imaging under rest and/or exercise or.
Is myoview stress test nuclear?
If coronary artery disease is present, a stress test with a nuclear isotope may be useful in detecting the presence and significance of CAD. Myoview (or Cardiolite) is a radioactive material that travels through the blood to your heart.
How does myoview work as a nuclear medicine?
A radioactive tracer (called Myoview) is injected into the patient's bloodstream and is taken up by the heart tissue. A single photon emission computed tomography (SPECT) camera detects the radiation released by the tracer to produce images of the heart.
How much does myoview cost?
The cost for Myoview intravenous powder for injection 1.38 mg is around $12,838 for a supply of 5 powder for injection, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
What kind of stress test takes 2 days?
A two-day Nuclear Cardiac Stress Imaging Test will take about 1 & 1/2 hours each day. Your appointment will start in the Cardiology Department. You will be directed where to go when you check in.
What are the side effects of a chemical stress test?
It causes blood vessels of the heart and other areas of the body to dilate. You may experience side effects such as shortness of breath, chest pain, headache, nausea, flushing, and throat or jaw pain.
Which is better echocardiogram or nuclear stress test?
Although stress echocardiography may have comparable ability to detect coronary artery disease, current data suggest that stress echocardiography detects significantly less jeopardized viable myocardium than stress nuclear myocardial perfusion imaging and consequently fewer patients at risk for cardiac events.
Is there an alternative to a nuclear stress test?
Even more options than these are available at major centers, including CT angiography, coronary MRI angiography, single-photon emission computed tomography (SPECT) myocardial perfusion imaging, and cardiac positron emission tomography (PET).
What does a Lexiscan feel like?
The lexiscan injection may cause a warm, flushing feeling. It is normal for your breathing rate, heart rate, blood pressure, and perspiration to increase during the test.
How accurate is a myocardial perfusion scan?
Myocardial perfusion imaging accuracy Myocardial perfusion imaging with SPECT cameras has been found to have an accuracy of between 44% to 70%, depending on which blood vessels are involved.
Are you radioactive after a nuclear stress test?
The radioactive liquid will be in your body for 24 to 36 hours after your test. You will need to do the following: Drink plenty of liquids as directed. This will help flush the radioactive liquid out of your body.
What is myoview imaging?
Myoview is indicated for scintigraphic imaging of the myocardium following separate administration s under exercise and/or resting conditions. It is useful in the delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium.
How many vials are in a Myoview kit?
The Myoview kit is supplied as a pack of five vials for use in the preparation of a technetium Tc99m tetrofosmin intravenous injection to be used for the scintigraphic delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium and for the evaluation of ventricular function. Each vial contains a predispensed, sterile, non-pyrogenic, lyophilized mixture of 0.23 mg tetrofosmin [6,9-bis (2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane], 0.03 mg stannous chloride dihydrate (minimum stannous tin 0.005 mg; maximum total stannous and stannic tin 0.0158 mg), 0.32 mg disodium sulphosalicylate and 1.0 mg sodium D-gluconate, and 1.8 mg sodium hydrogen carbonate. The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative.
Can Myoview be used for pregnant women?
Animal reproduction studies have not been conducted with Myoview. It is not known whether Myoview can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Therefore, Myoview should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.
What are the side effects of Myoview?
Common side effects of Myoview include: changes in smell. The recommended dose range for Myoview for rest or stress imaging is 185-1221 megabecquerels (MBq) [5-33 millicuries (mCi)] by intravenous administration. Myoview may interact with other drugs. Tell your doctor all medications and supplements you use.
What is a myoview kit?
Myoview (Kit for the preparation of technetium Tc99m tetrofosmin injection) for intravenous use is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease; and assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease. Common side effects of Myoview include:
Can adverse reactions be compared to myoview?
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of MYOVIEW cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can adverse reactions be compared to myoview?
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of MYOVIEW cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can you use Tetrafosmin 99m in pregnancy?
There are no data with technetium Tc 99m tetrafosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc 99m tetrofosmin have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering technetium Tc 99m tetrafosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Before taking Myoview, tell your doctor
If you are allergic to Myoview; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
What are some things I need to know or do while I take Myoview?
Tell all of your health care providers that you take Myoview. This includes your doctors, nurses, pharmacists, and dentists.
How is Myoview best taken?
Use Myoview as ordered by your doctor. Read all information given to you. Follow all instructions closely.
What are the side effects of Myoview that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
What are some other side effects of Myoview?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
If overdose is suspected
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Consumer information use and disclaimer
If your symptoms or health problems do not get better or if they become worse, call your doctor.
Myoview Description
Myoview - Clinical Pharmacology
Clinical Studies
Indications and Usage For Myoview
Warnings
Precautions
- General
To minimize radiation dose to the bladder, the patient should be encouraged to void when the examination is completed and as often thereafter as possible. Adequate hydration should be encouraged to permit frequent voiding. The contents of the Myoview vial are intended only for u… - Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been conducted to evaluate carcinogenic potential or effects on fertility. Tetrofosmin sulphosalicylate was not mutagenic in vitro in the Ames test, mouse lymphoma, or human lymphocyte tests, nor was it clastogenic in vivoin the mouse micronucleus test.
Adverse Reactions
Myoview Dosage and Administration
Radiation Dosimetry
Instructions For The Preparation of Myoview Injection