Rapiscan 400 micrograms Regadenoson Solution For Injection
What Is Rapiscan And What Rapiscan Used For?
Rapiscan contains the active substance regadenoson. It belongs to a group of medicines called “coronary vasodilators.” It causes the heart arteries to dilate and the heart rate to increase. This causes more blood to flow to the muscles of the heart. Intended for diagnostics only.
Rapiscan regadenoson is used in cardiac examination in adults called “myocardial perfusion imaging”. A diagnostic drug is used to create images in this type of examination.
These pictures show how well the blood flows to the heart’s muscles. Physical exertion is usually used on a pedal machine to load the heart before the examination. During physical exertion, a small amount of diagnostic drug is injected into the body, often into a vein in hand.
Then pictures are taken of the heart. When loaded, the doctor can see if the heart muscles get enough blood flow. If you cannot perform sufficient physical exertion to achieve the desired load on the heart, Rapiscan is injected to provide a load on the heart at the corresponding level and thus increase blood flow.
Rapiscan is also used in catheterization and imaging of arteries in the heart ( invasive coronary angiography) to dilate the heart vessels to measure the pressure differences caused by narrowing in one or more vessels.
During cardiac catheterization, a long narrow tube called a catheter is inserted, either through your femoral artery (via the groin) or your radicular artery (via the forearm) and runs through your blood vessels to the heart.
The catheterization doctor may also want to measure the pressure difference (fractional flow reserve) if constrictions are detected in one or more cardiovascular vessels.
What You Need To Know Before You Get Rapiscan?
Do Not Take Rapiscan:
- If you have a slow heart rate (high heart rate or sinus node disease) and do not have a pacemaker.
- If you have chest pain that occurs unpredictably ( 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 other ingredients of this medicine (listed in section 6).
Talk To Your Doctor Or Pharmacist Before Taking Rapiscan
Before you receive Rapiscan, your doctor needs to know the following:
- If you have recently had a serious heart problem ( such as a heart attack or abnormal heart rhythm ).
- If you have a heart rhythm where your heartbeat is very fast or irregular ( atrial fibrillation or atrial flutter ).
- If you have high blood pressure that is not controlled, especially if problems with nosebleeds, headaches or blurred vision, or double vision have recently accompanied this.
- If you have had problems with “mini” strokes (so-called TIA, transient ischemic attacks ).
- If you have a heart rhythm disorder called long QT syndrome.
- If you have episodes of heart block (which may lower your heart rate) or a very slow heart rate.
- If you have a cardiovascular condition that worsens when your blood pressure drops.
- These include low blood volume ( for example, caused by severe diarrhea or dehydration or diuretic tablets ), inflammation around the heart ( pericarditis ), and certain forms of a heart valve or artery disease ( for example, aortic or mitral stenosis ).
- If you have a condition that causes seizures, such as epilepsy, or if you have ever had seizures.
- If you have asthma or lung disease.
If any of these apply to you, tell your doctor before getting an injection.
Children And Young People:
This medicine should not be used in children and adolescents under 18.
Other Medicines And Rapiscan:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Take special care with the following medicines:
- Theophylline, a medicine used to treat asthma and other lung diseases, should not be used for at least 12 hours before receiving Rapiscan, as it may block the effect of Rapiscan.
- Dipyridamole, a medicine used to prevent blood clots, should not be used for at least two days before receiving Rapiscan, as it may alter the effect of Rapiscan.
Rapiscan With Food, Drink, And Alcohol:
Do not eat beverages containing caffeine (e.g., tea, coffee, cocoa, Coca-Cola, or chocolate) for at least 12 hours before receiving Rapiscan. This is because caffeine can interfere with the effects of Rapiscan.
Pregnancy And Breastfeeding:
Before you take Rapiscan, tell your doctor:
- If you are pregnant, think you may be pregnant or planning to have a baby. There is insufficient information on the use of Rapiscan in pregnant women. Harmful effects have been seen in animal studies, but it is unknown if there is a risk to humans. Your doctor will only give you Rapiscan if necessary.
- If you are breastfeeding, it is unknown if Rapiscan is excreted in human milk, and you will only get it if your doctor thinks it is necessary. You should avoid breastfeeding for at least 10 hours after receiving this medicine. Ask your doctor for advice before taking any medicine.
Driving And Using Machines:
Rapiscan can make you feel dizzy. It may cause other symptoms (headache or shortness of breath), affecting your ability to drive or use machines. These effects last no longer than 30 minutes. Do not drive or use any tools or machines until these symptoms have improved.
Rapiscan Contains Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per dose. After receiving Rapiscan, you will receive an injection of sodium chloride 9 mg/ml (0.9%) solution containing 45 mg of sodium. This should be considered if you have been prescribed a low-salt diet.
How Is Rapiscan given?
- Rapiscan is injected by a healthcare professional (a doctor, nurse, or biomedical analyst) into a medical device where your heart and blood pressure can be monitored. It is injected directly into a vein in a single dose of 400 micrograms in 5 ml solution – injection one takes about 10 seconds to complete. The injected dose does not depend on your weight.
- You will also receive an injection of sodium chloride 9 mg/ml (0.9%) solution (5 ml) and a small amount of diagnostic medicine.
- When you receive Rapiscan, your heart rate will increase rapidly. Your heart rate and blood pressure will be monitored.
- After injecting Rapiscan, you must sit or lie down until your heart rate and blood pressure return to normal. Your doctor, nurse, or biomedical analyst will tell you when you can get up.
- The examination of your heart is done when sufficient time has passed so that the diagnostic medicine has had time to reach the heart muscle.
- During catheterization of the vessels of the heart, your doctor can measure the pressure difference that occurs due to a narrowing of one or more vessels. This pressure difference is called the fractional flow reserve – FFR.
- If necessary, the 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 are monitored throughout the procedure.
If You Take More Rapiscan Than You Should:
Some people have developed redness, dizziness, and increased heart rate when they receive too much Rapiscan. If your doctor thinks you have serious side effects or the effects of Rapiscan last too long, you may be given an injection of a drug called aminophylline that reduces these effects.
Possible Rapiscan Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. The side effects are usually mild. They usually start shortly after injection of Rapiscan and are usually over within 30 minutes. They usually do not need any treatment.
More serious side effects include:
- Sudden cardiac arrest or damage to the heart, heart block (a disturbance of the heart’s electrical signal so that the signal can not be transmitted from the atrium to the ventricle), rapid heartbeat
- low blood pressure, which may result in fainting or minor strokes (including facial weakness or inability to speak). In rare cases, Rapiscan may cause a stroke (also known as a sudden cerebrovascular disorder)
- An allergic reaction that may cause rash, streaks, swelling under the skin near the eyes or throat, feeling of tightness in the throat, and difficulty breathing that may occur immediately or be delayed after injection of Rapiscan
Tell your doctor immediately if you think you have serious side effects. Your doctor may give you an injection of a medicine called aminophylline that reduces these effects.
Very common: (may affect more than 1 user in 10)
- Headache
- Dizziness
- Shortness of breath
- Chest pain
- Altered results in cardiac examinations ( electrocardiogram )
- Redness
- Discomfort in the stomach
Usual: (may affect up to 1 in 10 users)
- Heart pain (angina)
- Abnormal heart rhythm
- Fast heartbeat
- Feeling of the heart skipping a beat
- Fluttering or beating too hard or too fast (palpitations)
- Low blood pressure
- Congested throat
- Throat irritation
- Cough
- Vomiting
- Nausea
- Feeling sick or feeling weak
- Heavy sweating
- Pain in the back, arms, legs, neck, or jaw
- Discomfort in the skeleton and muscles
- Tingling
- Decreased sensation
- Taste changes
- Discomfort in the mouth
Uncommon: (may affect up to 1 in 100 users)
- Sudden cardiac arrest or damage to the heart, heart block (a disturbance of the heart’s electrical signal so that the signal can not be transmitted from the atrium to the ventricle)
- Slow heartbeat
- Seizures
- Fainting
- Minor strokes (including facial weakness or inability to speak)
- Decreased level of consciousness (which may include unconsciousness)
- Tremors
- Drowsiness
- An allergic reaction that can cause rash, streaks, swelling under the skin near the eyes or throat, feeling of tightness in the throat, difficulty breathing
- Hissing breathing
- Rapid breathing
- High blood pressure, pallor
- Cold extremity er
- Blurred vision
- Eye pain
- Anxiety
- Difficulty sleeping
- Ringing in the ears
- Flatulence, diarrhea, involuntary discharge of feces
- Reddening of the skin
- Joint pain
- Pain or discomfort around the injected area
- Body pain
No known frequency (frequency can not be calculated from available data)
- Breathing difficulties (bronchial spasm)
- Respiratory arrest
How To Store Rapiscan?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the vial and carton after EXP. No special storage instructions.
- Rapiscan must not be used if the solution is discolored or contains particles.
- Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment. Healthcare professionals will be responsible for the storage and destruction of this medicine.
Contents Of The Pack And Other Information:
Content Declaration
- The active substance in Rapiscan is regadenoson. Each 5 ml Rapiscan vial contains 400 micrograms of regadenoson.
- The other ingredients are disodium edetate, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, propylene glycol, and water for injections.
What The Medicine Looks Like And The Contents Of The Pack?
Rapiscan solution for injection is a clear, colorless solution with no visible particles. Rapiscan is delivered in a carton containing a 5 ml disposable vial with a rubber stopper and an aluminum sealed lid.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder:
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway
Manufacturer:
Millimount 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