Rapiscan 400 microgram solution for injection

Rapiscan contains the active substance, regadenoson. This belongs to a group of medicines called ?coronary vasodilators?. It makes the heart arteries expand and heart rate increase. This makes more blood flow to the muscles of the heart.

This medicine is for diagnostic use only.

Rapiscan is used in a type of heart scan in adults called ?myocardial perfusion imaging?.

Thescan uses a radioactive substance called a ?radiopharmaceutical? to create images. These images show how well blood flows to the muscles of the heart. Usually, exercise on a treadmill is used to put the heart under stress before a scan. During the exercise, a small amount of radiopharmaceutical is injected into the body, often into a vein in the hand. Images are then taken of the heart. The doctor can then see if the heart muscles are getting enough blood flow when it is under stress.

Rapiscan is used instead if someone is not able to exercise enough for the scan.

Your doctor will not give you Rapiscan

• if you are allergic(hypersensitive) to regadenoson or any of the other ingredients of Rapiscan listed in section 6 of this leaflet.
• if you have slow heart rate(high degree heart blockorsinus node disease), and don?t have a pacemaker fitted.
• if you have chest pain that occurs unpredictably (unstable angina) and that has not improved after treatment.
• if you have low blood pressure(hypotension).
• if you have heart failure.

Take special care with Rapiscan

Your doctor needs to know before you are given Rapiscan:

• if you have had a recent serious heart problem(for example a heart attack or abnormal heart rhythms).
• if you have a heart rhythm disorder called long QT syndrome.
• if you have episodes of heart block (which can slow the heart down) or a very slow heart rate.
• if you have any heart or blood vessel condition, particularly one that gets worse when your blood pressure decreases. These include low blood volume (caused, for example, by severe diarrhoea or dehydration or taking water pills), inflammation around the heart (pericarditis) and some forms of heart valve or artery disease (for example, aortic or mitral stenosis).
• if you have asthma or lung disease. If any of these apply to you, tell your doctor before the injection.

Children

Rapiscan should not be used in children below the age of 18 years.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without prescription.

Particular care should be taken with the following medicines:

• theophylline, a medicine used to treat asthma and other lung diseases, must not be used for at least 12 hours before you are given Rapiscan because it can block the effect of Rapiscan.
• dipyridamole, a medicine used to prevent blood clots, mustnot be used for at least two days before you are given Rapiscan because it can change the effect of Rapiscan.

Using Rapiscan with food and drink

Do not eat food or have drinks containing caffeine (for example, tea, coffee, cocoa, cola or chocolate) for at least 12 hours before you are given Rapiscan. This is because caffeine can interfere with the effect of Rapiscan.

Pregnancy and breast-feeding

Before you are given Rapiscan, tell your doctor:

• if you are pregnant or think you are pregnant. There is no adequate information on the use of Rapiscan in pregnant women. Harmful effects have been seen in animal studies but it is not known if there is a risk to humans. Your doctor will only give you Rapiscan if it is clearly necessary.
• if you are breast-feeding. It is not known whether Rapiscan can pass into breast milk and will only be given to you if your doctor thinks it is necessary. You should avoid breast-feeding for at least 10 hours after you are given Rapiscan.

Ask your doctor for advice before using any medicine.

Driving and using machines

Rapiscan may make you feel dizzy. It may cause other symptoms (headache or shortness of breath) that could affect your ability to drive or use machinery. These effects usually do not last longer than 30 minutes. Do not drive or operate machinery until these effects have improved.

Important information about some of the ingredients of Rapiscan

This medicine contains less than 1 mmol sodium (23 mg) per dose. After you have been given Rapiscan, you will be given an injection of sodium chloride 9 mg/ml (0.9%) solution which contains 45 mg of sodium. To be taken into consideration if you are on a controlled sodium diet.

Rapiscan is injected by a healthcare professional (a doctor, nurse or medical technician) in a medical facility where your 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 about 10 seconds to complete. The dose injected does not depend on your weight.

You will also be given an injection of sodium chloride 9 mg/ml (0.9%) solution (5 ml), and an injection of a small amount of a radioactive substance (radiopharmaceutical).

When you are given Rapiscan, your heart rate will increase quickly. Your heart rate and blood pressure will be monitored.

After the Rapiscan injection, you will need to sit or lie down until your heart rate and blood pressure return to your normal levels. The doctor, nurse or medical technician will let you know when you can stand up.

A scan of your heart will be made after enough time has passed to allow the radiopharmaceutical to reach the heart muscle.

If you are given more Rapiscan than you should

Some people have had flushing, dizziness and increased heart rate when they have been given too much Rapiscan. If your doctor thinks that you are having severe side effects, or the effects of Rapiscan are lasting too long, they may give you an injection of a medicine called aminophylline that reduces these effects.

Like all medicines, Rapiscan can cause side effects, although not everybody gets them.

The side effects are usually mild. They normally start soon after the Rapiscan injection and are usually over within 30 minutes. They don?t usually need any treatment.

More serious side effects include:

• sudden stopping of the heart or damage to the heart, heart block (a disorder of the heart?s electrical signal, where the signal cannot pass from the upper to the lower chambers), rapid heart beat
• low blood pressure which may result in fainting or mini strokes (including weakness of the face or an inability to speak)

Tell your doctor straight away if you think you are having severe side effects. Your doctor may then give you an injection of a medicine called aminophylline that reduces these effects.

Very common side effects

(affects more than 1 user in 10)

• headache, dizziness
• shortness of breath
• chest pain
• changes in heart tracing tests (electrocardiogram)
• flushing
• discomfort in the stomach

Common side effects

(affects 1 to 10 users in 100)

• heart pain (angina), abnormal heart rhythms, rapid heart beat, feeling the heart skipping a beat, fluttering, or beating too hard or fast (palpitations)
• low blood pressure
• throat tightness, throat irritation, cough
• being sick (vomiting), feeling sick (nausea)
• feeling unwell or weak
• excessive sweating
• pain in the back, arms, legs, neck or jaw
• discomfort in the bones and muscles
• pins and needles, reduced sensation, taste changes
• discomfort in the mouth

Uncommon side effects

(affects 1 to 10 users in 1,000)

• sudden stopping of the heart or damage to the heart, heart block (a disorder of the heart?s electrical signal, where the signal cannot pass from the upper to the lower chambers), slow heart beat
• fits, fainting, mini strokes (including weakness of the face or an inability to speak), reduced responsiveness (which may include a comatose state), trembling, sleepiness
• rapid breathing
• high blood pressure, paleness, cold extremities
• blurred vision, eye pain
• anxiety, difficulty sleeping
• ringing in the ears
• bloating, diarrhoea, involuntary loss of faeces
• redness of the skin
• pain in the joints
• pain or discomfort around the area injected, body pain

If any side effects last longer than one hour or if they worry you (even side effects not listed in this leaflet), tell a doctor or nurse.

Keep out of the reach and sight of children.

Do not use Rapiscan after the expiry date which is stated on the vial and carton after EXP.

This medicine does not require any special storage conditions.

Do not use the solution if it is discoloured or particulate matter is present.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Rapiscan contains

The active substance in Rapiscan is regadenoson. Each 5 ml vial of Rapiscan contains 400 micrograms of regadenoson.

The other ingredients are: disodium edetate, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, water for injections.

What Rapiscan looks like and contents of the pack

Rapiscan solution for injection is a clear, colourless solution with no particles visible. Rapiscan is supplied in a carton containing a single use 5 ml glass vial with a rubber stopper and aluminium sealed cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Rapidscan Pharma Solutions EU Ltd.
Regent?s Place
338 Euston Road
London NW1 3BT
United Kingdom

Manufacturer:
Gilead Sciences Limited
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

This leaflet was last approved in

The following information is intended for medical or healthcare professionals only:

Rapiscan should be administered as a rapid, 10-second injection into a peripheral vein using a 22-gauge or larger catheter or needle.

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

The radiopharmaceutical for the myocardial perfusion imaging agent should be administered 10-20 seconds after the sodium chloride 9 mg/ml (0.9%) solution for injection. The radiopharmaceutical may be injected directly into the same catheter as Rapiscan.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

This medicinal product should be inspected visually for particulate matter and discolouration prior to administration.

Any unused product or waste material should be disposed of in accordance with local requirements.

For further information, please refer to the complete Summary of Product Characteristics enclosed with the pack.