RAPISCAN 400 MCG Инъекционный раствор

Содержание инструкции

1. Rapiscan 400 microgram solution for injection
   1. What is Rapiscan and what is it used for
   2. What you need to know before you receive Rapiscan
   3. How to administer Rapiscan
   4. Possible side effects
   5. How to store Rapiscan
   6. Package Contents and Other Information

Rapiscan 400 microgram solution for injection

Regadenoson

Read this leaflet carefully before you receive this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Rapiscan is and what it is used for
• 2. What you need to know before you receive Rapiscan
• 3. How Rapiscan is administered
• 4. Possible side effects
• 5. How to store Rapiscan
• 6. Contents of the pack and other information

1. What is Rapiscan and what is it used for

Rapiscan contains the active substance regadenoson, which belongs to a group of medicines called

‛coronary vasodilators ’. Regadenoson dilates the arteries of the heart and increases the heart rate.
In this way, a greater amount of blood flows to the heart muscle.
This medicine is for diagnostic use only.
Rapiscan is used in adults for a type of heart scan, called ‛myocardial perfusion imaging’.
In the scan, a diagnostic agent is used to obtain images. These images show
how blood flows to the heart muscle. Generally, before the scan, the patient
walks on a treadmill to put the heart under stress. During exercise, a small amount of diagnostic
agent is injected into the body, usually into a vein in the hand.
Subsequently, images of the heart are created. The doctor is then able to see if the
heart muscle receives enough blood when it is under stress.
If you are unable to exert enough energy to achieve sufficient stress on the heart,
Rapiscan will be injected to provide the heart with a similar level of stress to increase blood
flow.
Rapiscan is also used during heart catheterizations and imaging of the heart arteries
(invasive coronary angiography) to expand the heart arteries to measure the pressure difference,
caused by a narrowing inside one or more arteries. During cardiac catheterization,
a long, thin tube called a catheter is inserted through the femoral or radial artery and threaded
through the blood vessels to the heart. The doctor performing the catheterization may also want to
measure the pressure difference (fractional flow reserve) due to a narrowing detected in
one or more of the heart arteries.

2. What you need to know before you receive Rapiscan

Do not take Rapiscan:

• if you have a slow heartbeat (high-degree heart block or sinus node disease) and do not have a pacemaker.
• if you have chest pain that comes on unexpectedly (unstable angina) and has not improved

after treatment.

• if you have low blood pressure (hypotension).
• if you have heart failure.
• if you are allergic to regadenoson or any of the other ingredients of Rapiscan listed at the

Talk to your doctor or nurse before taking Rapiscan
Before administering Rapiscan to you, your doctor needs to know:

• if recentlyyou have had a serious heart problem(such as a heart attack or anirregular heartbeat) .
• if you have a heartbeat characterized by a very fast or irregular rhythm (atrial fibrillation or atrial flutter).
• if you suffer from uncontrolled high blood pressure, especially if accompanied by recent episodes of nosebleeds, headache, blurred or double vision.
• if you have had episodes of mini-strokes (known as transient ischemic attacks).
• if you have a heart rhythm disorder called long QT syndrome.
• if you have episodes of heart block(which can slow down the heartbeat) or a very slow heartbeat.
• if you have any heart or blood vessel condition, especially if this worsenswhen blood pressure decreases. These conditions include low blood volume (caused, for example, by severe diarrhea or dehydration or by taking diuretics), inflammation around the heart (pericarditis) and some forms of heart valve or artery disease (e.g., aortic or mitral stenosis).
• if you suffer from a condition that causes seizures (convulsions) such as epilepsy or if you have suffered from it.
• if you suffer from asthmaor a lung disease. If you have any of these conditions, tell your doctor before you are given the injection.

Children and adolescents
Rapiscan should not be used in children and adolescents under 18 years of age.

Other medicines and Rapiscan
Tell your doctor if you are taking, have recently taken or might take any other
medicine.

Pay particular attention with the following medicines:

• theophylline, a medicine used to treat asthma and other lung diseases, must notbe used for at least 12 hours beforereceiving Rapiscan, because it can block the effect of Rapiscan.
• dipiridamole, a medicine used to prevent blood clots, must not beused for at least two days beforereceiving Rapiscan, because it can change the effect of Rapiscan.

Rapiscan with food and drink
Do not take foods or drinks containing caffeine (e.g. tea, coffee, chocolate, cola or
chocolate) for at least 12 hours before receiving Rapiscan. Caffeine can interfere with the effect of
Rapiscan.

Pregnancy and breastfeeding
Tell your doctor before receiving Rapiscan:

• if you are pregnant, suspect you are pregnant or are planning a pregnancy. There is not enough information about the use of Rapiscan in pregnant women. Harmful effects have been observed in animal studies, but it is not known whether there is a risk to humans. Your doctor will only give you Rapiscan if necessary.
• if you are breastfeeding.It is not known whether Rapiscan passes into breast milk and the medicine will only be given to you if your doctor considers it necessary. Avoid breastfeeding for at least 10 hours after

receiving Rapiscan.
Ask your doctor for advice before using any medicine.

Driving and operating machinery
Rapiscan can cause dizziness. It can also cause other symptoms (headache or shortness of breath) that can
affect your ability to drive or operate machinery. Generally, these effects do not last more than 30
minutes. Do not drive and do not use machinery until your symptoms improve.

Rapiscan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose. After taking Rapiscan,
you will be given a solution of sodium chloride 9 mg/ml (0.9%) containing 45 mg of sodium. This should
be taken into consideration if you have reduced kidney function or are following a low-sodium diet.

3. How to administer Rapiscan

Rapiscan is injected by a healthcare professional(a doctor, nurse or healthcare technician)
in a medical facility where heart rate and blood pressure can be monitored. The
medicine is injected directly into a vein, in a single dose of 400 micrograms in a
solution of 5 ml. The injection will last approximately 10 seconds. The injected dose is not dependent on body
weight.

You will also be injected witha solution of sodium chloride 9 mg/ml (0.9%) (5 ml) and a small
amount of diagnostic agent.

When you receive Rapiscan, your heart rate will increase rapidly. Heart rate and blood pressure will be monitored.

After the injection of Rapiscanyou will need to sit or lie down until your heart rate and
blood pressure return to their normal values. The doctor, nurse or healthcare technician will
tell you when you can get up.
A scan of the heart will be performed after a sufficient time has elapsed to
allow the diagnostic agent to reach the heart muscle.
During catheterization of the heart arteries, the doctor may measure the pressure difference
(also known as fractional flow reserve - FFR) due to a narrowing in one or more arteries
of the heart.
If deemed necessary, a second dose of 400 micrograms may be injected at least 10 minutes
after the first dose for this measurement of the pressure difference during the same
catheterization procedure. Heart rate and blood pressure will be monitored throughout the
procedure.

If you receive more Rapiscan than you should
Some people have experienced flushing, dizziness and increased heart rate
after receiving an excessive amount of Rapiscan. If the doctor believes that serious side
effects occur or that the effect of Rapiscan lasts too long, they may administer an injection of
a medicine called aminophylline, which reduces these effects.

4. Possible side effects

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

Side effects are usually mild.They normally appear shortly after the injection of
Rapiscan and disappear usually within 30 minutes. They generally do not need to be treated.

More serious side effects include:

• sudden stopping of the heart or heart damage, heart block (a disturbance of the heart's electrical signals, where signals do not pass from the upper to the lower chambers), rapid heartbeat
• low blood pressure, which can cause fainting or mini-stroke (including facial weakness or inability to speak). In rare cases Rapiscan can cause a stroke (also known as a cerebrovascular accident)
• an allergic reaction accompanied by rash, blisters, swelling under the skin near the eyes or throat, tightness in the throat and difficulty breathing may occur immediately after the injection of Rapiscan or after some time.

Tell your doctor immediately if you think you have serious side effects. The doctor may
give you an injection of a medicine called aminophylline, which reduces these effects.

Very common

(may affect more than 1 in 10 people)

• headache, dizziness
• shortness of breath
• chest pain
• changes in heart activity test (electrocardiogram)
• skin flushing
• stomach discomfort

Common

(may affect up to 1 in 10 people)

• heart pain (angina), irregular heartbeat, rapid heartbeat, feeling of missed heartbeat, sensation of fluttering or beating too hard or fast (palpitations)
• low blood pressure
• tightness in the throat, throat irritation, cough
• vomiting, nausea
• feeling unwell or weak
• excessive sweating
• pain in the back, arms, legs, neck or jaw
• feeling of discomfort in bones and muscles
• tingling, reduced sensation, altered taste
• feeling of discomfort in the mouth

Uncommon

(may affect up to 1 in 100 people)

• sudden stopping of the heart or heart damage, heart block (a disturbance of the heart's electrical signals, where signals do not pass from the upper to the lower chambers), slow heartbeat
• convulsions, fainting, mini-stroke (including facial weakness or inability to speak), reduced ability to react (which may include a comatose state), tremor, drowsiness
• an allergic reaction accompanied by rash, blisters, swelling under the skin near the eyes or throat, tightness in the throat, difficulty breathing
• wheezing
• rapid breathing
• high blood pressure, paleness, cold extremities
• blurred vision, eye pain
• anxiety, difficulty sleeping
• ringing in the ear
• flatulence, diarrhea, involuntary loss of stool
• erythema
• joint pain
• pain or discomfort around the injection site, body pain

Not known

(frequency cannot be estimated from the available data)

• difficulty breathing (bronchospasm)
• respiratory arrest

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Rapiscan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial after EXP and on the
pack after Scad. This medicine does not require any particular storage conditions.
Do not use this medicine if you notice changes in colour or the presence of particles.
Do not dispose of any medicine in wastewater or household waste. This will help protect
the environment. Healthcare professionals are responsible for the storage and disposal of this
medicine.

6. Package Contents and Other Information

What Rapiscan contains
The active ingredient in Rapiscan is regadenoson. Each vial of Rapiscan solution
for injection contains 400 micrograms of regadenoson in 5 ml of solution.
The other ingredients are: disodium edetate, disodium phosphate, sodium dihydrogen phosphate, propylene
glycol, water for injections.

Description of the appearance of Rapiscan and contents of the pack
Rapiscan solution for injection is a clear and colourless solution free from visible particles. Rapiscan is
available in a carton containing one single-use vial with a rubber stopper and an aluminium crimp seal.
Rapiscan is available in glass vials of 5 ml or 7 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway
Manufacturer:
Millmount Healthcare Limited,
Block 7, City North Business Campus,
Stamullen, Co Meath, K32 YD60
Ireland
Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder Str. 5
D-82515 Wolfratshausen,
Germany
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the
European Medicines Agency website.

The following information is intended exclusively for healthcare professionals:
Rapiscan must be administered as a rapid injection over 10 seconds into a peripheral vein,
using a catheter or a 22 gauge or larger diameter needle.
Immediately following the Rapiscan injection, 5 ml of sodium chloride 9 mg/ml (0.9%) injectable
solution must be administered.
The diagnostic agent for myocardial perfusion imaging must be administered 10-20 seconds
after the sodium chloride 9 mg/ml (0.9%) injectable solution. The diagnostic agent may be
injected directly into the same catheter used for Rapiscan.
For FFR measurement, Rapiscan must be administered via a rapid 10-second injection into a
peripheral vein, using a catheter or needle of 22 gauge or larger. 10 ml of sodium chloride 9 mg/ml
(0.9%) injectable solution must be administered immediately after the Rapiscan injection. Standard
catheterization and FFR measurement techniques must be followed. FFR should be measured as the
lowest Pd/Pa value achieved during maximal hyperemic steady state.
If deemed necessary, a second dose of 400 micrograms may be injected at least 10 minutes
after the first dose for that FFR measurement during the same catheterization procedure.
In the absence of compatibility studies, this medicine should not be mixed with other medicines.
Before administration, the medicine should be visually inspected for the presence of particulate
matter and colour changes.
Unused medicine and waste materials derived from such medicine should be disposed of in accordance
with local regulations.
For further information, see the Summary of Product Characteristics.