Label: Information for the User

Rapiscan 400 micrograms Injectable Solution

Regadenoson

Read this label carefully before the medicine is administered to you, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See Section 4.

Rapiscan contains the active ingredientregadenosón. This belongs to a group of medications called “coronary vasodilators”. It makes the heart arteries expand and the heart rate increases. This allows more blood flow to the heart muscles.

This medication is solely for diagnostic use.

Rapiscan is used in a type of heart exploration in adults called“myocardial perfusion imaging study”.

The imaging study uses a radioactive substance called “radiocontrast agent” to create images. These images show if the blood flow is going to the heart muscles. Usually, a treadmill test is used to subject the heart to stress before performing the imaging study. During the exercise, a small amount of radiocontrast agent is injected into the body, often through a vein in the hand. Subsequently, images of the heart are obtained, so that the doctor can check if the heart muscles are receiving sufficient blood flow when under stress.

If you cannot perform enough exercise to achieve a sufficient heart rate, Rapiscan will be injected to provide a heart rate that can increase blood flow in a similar way.

Rapiscan is also used during cardiac catheterization and visualization of the heart arteries (invasive coronary angiography) to expand the heart arteries and measure the difference in pressure, caused by a narrowing within one or more arteries. During cardiac catheterization, a long and thin tube called a catheter is inserted through the femoral or radial artery and passed through the blood vessels to the heart. The doctor performing the catheterization may also want to measure the difference in pressure (fractional flow reserve) due to a narrowing detected in one or more heart arteries.

No use Rapiscan

Consult your doctor or nurse before using Rapiscan

Your doctor needs to know the following before administering Rapiscan:

Inform your doctor if you have any of the above before the injection is administered.

Children and adolescents

Rapiscan should not be used in children or adolescents under 18 years old.

Use of Rapiscan with other medications

Inform your doctor if you are using or have recently used other medications, including those purchased without a prescription.

Special caution with the following medications:

Use of Rapiscan with food and drinks

Do not eat food or drink beverages containing caffeine (such as tea, coffee, cocoa, cola, or chocolate) for at least 12 hours before receiving Rapiscan. This is because caffeine may interfere with the effect of Rapiscan.

Pregnancy and breastfeeding

Inform your doctor:

Consult your doctor before using any medication.

Driving and operating machinery

Rapiscan may cause dizziness. It may also cause other symptoms (headache or difficulty breathing) that may affect your ability to drive or operate machinery. These effects usually do not last more than 30 minutes. Do not drive or operate machinery until these effects have improved.

Rapiscan contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose. After receiving Rapiscan, you will be administered an injection of a 9 mg/ml (0.9%) sodium chloride solution, which contains 45 mg of sodium. This should be taken into account if you are on a low-sodium diet.

Rapiscan is administered by a healthcare professional (a doctor, a nurse, or a medical technician) in a medical center where the heart and blood pressure can be monitored. It is injected directly into a vein as a single dose of 400 micrograms in a 5 ml solution; the injection will take approximately 10 seconds to complete. The injected dose does not depend on your weight.

You will also be administered an injection of a sodium chloride solution at a concentration of 9 mg/ml (0.9%) (5 ml) and an injection of a small amount of a radioactive substance (radiocontrast agent).

When Rapiscan is administered your heart rate will increase rapidly. Your heart rate and blood pressure will be monitored.

After the Rapiscan injection you will need to remain seated or lying down until your heart rate and blood pressure return to normal levels. The doctor, nurse, or medical technician will tell you when you can stand up.

An imaging study of the heart will be performed once enough time has passed for the radiocontrast agent to reach the heart muscle.

During coronary artery catheterization, your doctor may measure the pressure difference (also known as fractional flow reserve - FFR) due to narrowing in one or more coronary arteries.

If necessary, a second dose of 400 micrograms may be injected at least 10 minutes after the first dose to measure the pressure difference during the same catheterization procedure. Heart rate and blood pressure will be monitored throughout the procedure.

If you are administered more Rapiscan than you should

Some people have experienced flushing, dizziness, and increased heart rate when they have been administered too much Rapiscan. If your doctor considers that you are experiencing severe adverse effects or if the effects of Rapiscan are lasting too long, it may be possible that you will be administered an injection of a medication called aminophylline, which reduces these effects.

Like all medicines, Rapiscan may cause side effects, although not everyone will experience them.

Side effects are usually mild. They typically start shortly after receiving the Rapiscan injection andusually disappear within 30 minutes. They usually do not require any treatment.

The most serious side effects include:

Inform your doctor immediately if you think you are experiencing serious side effects. Your doctor may then administer an injection of a medication called aminophylline, which reduces these side effects.

Very common side effects

(affects more than 1 in 10 people)

Common side effects

(affects between 1 and 10 people in every 100)

Uncommon side effects

(affects between 1 and 10 people in every 1,000)

Side effects of unknown frequency

(cannot be estimated from available data)

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAnnex V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use Rapiscan after the expiration date appearing on the vial and the packaging after EXP/CAD.

This medication does not require special storage conditions.

Rapiscan should not be used if the solution shows color changes or solid particles.

Medicines should not be disposed of through drains or in the trash. This will help protect the environment. Healthcare professionals will be responsible for the storage and disposal of this medication.

Composition of Rapiscan

The active principle present in Rapiscan is regadenosón. Each vial of 5 ml of Rapiscan contains 400 micrograms of regadenosón.

The other components are: edetate disodium, dihydrogen phosphate disodium dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, water for injectable preparations.

Appearance of the product and contents of the package

Rapiscan injectable solution is a transparent and colorless solution without visible particles. Rapiscan is supplied in a package containing a 5 ml glass vial for single use with a rubber stopper and an aluminum closure cap.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

GE Healthcare AS

Nycoveien 1

NO-0485 Oslo

Norway

Responsible manufacturer:

AndersonBrecon (UK) Limited

Wye Valley Business Park

Hay-on-Wye, Hereford

HR3 5PG

United Kingdom

Millmount Healthcare Limited,

Block 7, City North Business Campus,

Stamullen, Co Meath, K32 YD60,

Ireland

Last approval date of this leaflet MM/AAAA

Other sources of information

The detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area

This information is intended solely for healthcare professionals:

Rapiscan should be administered as a rapid 10-second injection in a peripheral vein using a catheter or needle of caliber 22 or larger.

Immediately after the injection of Rapiscan, 5 ml of injectable solution of sodium chloride 9 mg/ml (0.9%) should be administered.

The myocardial perfusion imaging radiopharmaceutical should be administered 10-20 seconds after the injectable solution of sodium chloride 9 mg/ml (0.9%). The radiopharmaceutical may be injected directly into the same catheter used to administer Rapiscan.

For FFR measurement, Rapiscan should be administered as a rapid 10-second injection in a peripheral vein using a catheter or needle of caliber 22 or larger. Immediately after the injection of Rapiscan, 10 ml of injectable solution of sodium chloride 9 mg/ml (0.9%) should be administered. Standard catheterization and FFR measurement techniques should be followed, and FFR should be measured as the lowest Pd/Pa value achieved during maximum hyperemia in a stable state.

If necessary, a second dose of 400 micrograms may be administered at least 10 minutes after the first dose to measure FFR during the same catheterization procedure.

In the absence of compatibility studies, this medicine should not be mixed with other medications.

Before administration, this medicine should be visually inspected to determine if it contains solid particles or color changes.

The disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.

For more information, see the Technical Dossier or Complete Product Characteristics Summary.