Adenosine 30mg/10ml Solution For Infusion
158 mm
iceuticals Ltd
Read all of this leaflet carefully before you are given this medicine because It contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Adenosine Solution for Infusion is and what it is used for
2. What you need to know before you are given Adenosine Solution for Infusion
3. How you will be given Adenosine Solution for Infusion
4. Possible side effects
5. How to store Adenosine Solution for Infusion
6. Contents of the pack and other information
l.What Adenosine Solution for Infusion is and what it is used for
Adenosine 30mg/10ml Solution for Infusion (called Adenosine Solution for Infusion throughout the rest of this leaflet) belongs to a group of medicines called coronary vasodilators. Adenosine Solution for Infusion is given with other medicines, called radionuclides, during a diagnostic test, called myocardial perfusion imaging, to open up your heart’s blood vessels to allow your blood to flow more freely. Once in your blood, the radionuclide allows the doctor or nurse to see your heart and assess your heart condition. This medicine is for diagnostic use only and is used if you are incapable of exercise. You will usually be in hospital when you receive this medicine.
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2.What you need to know before you are given Adenosine Solution for Infusion
Do not have Adenosine Solution for Infusion
if you are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6);
if you have an irregular heart rhythm and do not currently have a pacemaker fitted; if you have a disorder that affects the heart’s electrical activity (Long QT syndrome); if you have very low blood pressure (severe hypotension);
if you have unstable angina (severe chest pain) that is not currently controlled by either treatment or medication; if you have a type of heart failure where your heart does not pump out enough blood; if you have asthma or any other severe breathing problems;
if you are taking a medicine called dipyridamole, used to thin the blood; if you are below 18 years of age. The use of Adenosine Solution for Infusion in children and adolescents has not been sufficiently studied. Tell your doctor or nurse if any of the following apply to you:
if you have recently had a heart attack, heart failure, or you have had a heart transplant within the last year;
if you have a low blood volume level that has not been corrected by either treatment or medication;
if you have a type of heart disease caused by
the narrowing of your heart valves;
if your heart is inflamed, enlarged, or you have
fluid around your heart;
• if you have seizures or convulsions (fits);
• if you have difficulty breathing;
• if you suffer from problems with your autonomic nervous system;
• if you suffer from a narrowing of the main arteries in your neck (carotid arteries) that prevents sufficient blood getting to your brain
• if you have a known heart defect;
• if you have an unusual heart rhythm (atrial fibrillation or flutter).
Using other medicines Make sure your doctor or nurse knows if you are taking, or have recently taken, any of the medicines listed here:
• Dipyridamole (used to thin the blood); taking dipyridamole at the same time as Adenosine Solution for Infusion will increase the effect of adenosine on the body. Your doctor or nurse may decide not to give you Adenosine Solution for Infusion, may tell you to stop taking dipyridamole 24 hours before you are given Adenosine Solution for Infusion, or they may lower the dose.
• Aminophylline and theophylline (used to help breathing difficulties), or medicines containing Xanthines (caffeine), which are found in certain medicines used to treat headaches Your doctor may tell you to stop taking these medicines 24 hours before you are given Adenosine Solution for Infusion.
• Medicines that affect the rate at which your heart conducts electrical impulses such as calcium channel blockers e.g. diltiazem anc amlodipine, beta-adrenergic blocking agents e.g. propranolol and metoprolol and centrally acting agents e.g. clonidine and guanfacine.
Please also tell your doctor or nurse if you are taking, or have recently taken, any other medicines, including medicines obtainec without a prescription.
Taking Adenosine Solution for Infusion with food and drink
• Where possible, do not drink or eat products containing caffeine, such as tea, coffee chocolate, or cola, for at least 12 hours before you are given Adenosine Solution for Infusion.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before they give you this medicine.
• You should not be given this medicine if you are breast-feeding.
Important information about some of the other ingredients in Adenosine Solution for Infusion
• Your medicine contains sodium (salt). This medicinal product contains 3.54mg (0.15mmol) of sodium (salt) per 1 ml of solution To be taken into consideration by patients on a controlled sodium (salt) diet.
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3. How you will be given Adenosine Solution for Infusion
You will usually be in hospital when you are given Adenosine Solution for Infusion. You will be given it by a doctor or nurse, as an infusion, into your vein. Your heart and blood pressure will be closely monitored.
Adults and the elderly
• The dose is based on your body weight.
• Your doctor or nurse will decide how much to give you.
• The usual dose is 140 micrograms per kilogram, per minute, given over a period of six minutes.
Technical Leaflet intended for healthcare professionals only ADENOSINE 30MG/10ML SOLUTION FOR INFUSION GENERAL INFORMATION
Adenosine 30mg/10ml Solution for Infusion is for single use only. Any portion of the vial, not used at once, should be discarded.
THERAPEUTIC INDICATIONS
Intravenous (IV) Adenosine 30mg/10ml Solution for Infusion is a coronary vasodilator, for use in conjunction with radionuclide myocardial perfusion imaging, in patients who cannot exercise adequately or for whom exercise is inappropriate.
Adenosine 30mg/10ml Solution for Infusion is indicated in adults.
POSOLOGY AND METHOD OF ADMINISTRATION
Adenosine 30mg/10ml Solution for Infusion is intended for use in hospitals. It should be administered following the same procedure as for exercise testing, where facilities for cardiac monitoring and cardio-respiratory resuscitation are available for immediate use, if necessary.
During administration of Adenosine 30mg/10ml Solution for Infusion, continuous electrocardiogram (ECG) control i: necessary, as life-threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute.
Adults:
1. Adenosine 30mg/10ml Solution for Infusion should be administered undiluted, as a continuous periphera intravenous infusion, at a dose of 140 pg/kg/min for six minutes using an infusion pump. Separate venous sites for Adenosine 30mg/10ml Solution for Infusion anc radionuclide administration are recommended to avoid an adenosine bolus effect.
2. After three minutes of infusion of Adenosine 30mg/10m Solution for Infusion, the radionuclide is injected to ensure sufficient time for peak coronary blood flow to occur. The optimal vasodilator protocol is achieved with six minutes of infusion of Adenosine 30mg/10ml Solution for Infusion.
3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the infusion of Adenosine 30mg/10ml Solution for Infusion.
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Children
The safety of Adenosine Solution for Infusion in children is not known. Therefore, it is not recommended for use in children. If the doctor or nurse decides that this medicine is needed, they will determine the most appropriate dose to give.
If you are given too much Adenosine Solution for Infusion
As this medicine is given to you by a doctor or nurse, it is unlikely that you will be given too much. However, if you are given too much medicine, the following side effects may occur: an extreme lowering in blood pressure; a lowering in heart rate; a heart problem.
Adenosine stays in the blood for a very short period of time. Therefore, any side effects would soon subside once the infusion has been stopped. You may be given a medicine called aminophylline or theophylline to help with any side effects experienced.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Other side effects which may occur:
• fainting or loss of consciousness
• convulsions (fits)
• cardiac arrest (a sudden loss of heart function)
• stopping breathing (respiratoryfailure or arrest)
• fast, uneven or abnormal heartbeat
• asystole (a severe and fatal heart problem)
• nausea (feeling sick) or vomiting (being sick) Very rare effects which may occur at the site of injection (affecting up to 1 in 10,000 people):
• redness
• itching
• pain
• abscesses
• swelling
• swollen and painful veins You will be observed by medical staff at all times, whilst being given Adenosine Solution foi Infusion, to monitor the effects on your heart.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects after you have been given your medicine, tell your doctor or nurse immediately. If you are not in hospital, you MUST GO straight away.
• Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away.
• Severe chest pain.
• An extreme lowering in heart rate.
• An extreme lowering in blood pressure.
• Respiratory failure.
Very common side effects (may affect more than 1 in 10 people):
chest pain or pressure on the chest
flushing (sudden reddening of the skin
accompanied by the feeling of heat)
shortness of breath or the urge to take a deep
breath
headache
abdominal discomfort
Common side effects (may affect up to 1 in 10 people):
low blood pressure irregular heart rhythms dizziness or feeling light headed throat, neck or jaw discomfort dry mouth
numbness, tingling, prickling or burning of the skin
Uncommon side effects (may affect up to 1 in 100 people):
apprehension (feeling nervous)
metallic taste in your mouth
discomfort in the leg, arm or back
feeling of general weakness, discomfort or pain
sweating
slow heartbeat
Rare side effects (may affect up to 1 in 1000 people):
blurred vision nipple discomfort
ringing or buzzing in your ears (tinnitus)
feeling the sudden need to urinate
drowsiness
blocked nose
difficulty breathing
shaking (tremors)
5.How to store Adenosine Solution for Infusion
This medicine will be stored, by your doctor, nurse or pharmacist out of the sight and reach of children This medicine should not be used after the expiry date stated on the carton and vial label. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
This product is for single use only. Once your doctor or nurse has opened the vial, it should be used immediately. Any remaining Adenosine Solution for Infusion must be thrown away by the doctor or nurse
6.Contents of the pack and other information
What Adenosine Solution for Infusion contains
- The active substance is adenosine. Each 10ml vial contains 30mg adenosine (3mg per ml).
- The other ingredients are sodium chloride and water for injections.
What Adenosine Solution for Infusion looks like and contents of the pack Adenosine Solution for Infusion (Adenosine Infusion) is a clear, colourless solution in a clear, glass vial Each vial contains 10ml of medicine. This product is available in cartons containing 6 x 10ml vials. Marketing Authorisation Holder Focus Pharmaceuticals Limited, Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, UK.
Tel: 00 44(0)1283 495280
Fax: 00 44(0)1283 495290
Email: medinfos’focuspharma. co.uk
Manufacturer Vianex S.A., Plant A, 12km National Road Athinon-Lamias, Metamorfosi Attiki, 14451, Greece For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.
This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom: Adenosine 30mg/10ml Solution for Infusion
Ireland: Adcus™3mg/ml Solution for Infusion Greece: ADENORYTHM® 3mg/ml AidAupa yia syxuan This leaflet was last revised in 06/2015 Other sources of information For information in large print, audio CD or Braille please telephone 00 44 (0)1283 495 280 or email medinfo@focuspharma.co.uk.
The table below is given as a guide for adjustment of the nfusion rate of undiluted Adenosine 30mg/l 0ml Solution for nfusion, in line with bodyweight (total dose 0.84 mg/kg).
|
5atient Weight (kg) |
Infusion Rate (ml/min) |
|
45-49 |
2.1 |
|
50-54 |
2.3 |
|
55-59 |
2.6 |
|
60-64 |
2.8 |
|
65-69 |
3.0 |
|
70-74 |
3.3 |
|
75-79 |
3.5 |
|
80-84 |
3.8 |
|
85-89 |
4.0 |
|
90-94 |
4.2 |
|
95-99 |
4.4 |
|
100-104 |
4.7 |
Paediatrics:
The safety and efficacy of Adenosine 30mg/10ml Solution for Infusion in children aged 0 to 18 years have not been established. Currently available data are described in section 5.1 of the Summary of Product Characteristics but no recommendation on a posology can be made.
Elderly:
See dosage recommendations for adults.
STORAGE AND DISPOSAL OF ADENOSINE 30MG/10ML SOLUTION FOR INFUSION
This medicinal product does not require any special storage conditions.
The product should be inspected visually for particulate matter and colouration prior to administration. Where the visual appearance of the product may have changed, the vial should be discarded.
Dispose of any remaining solution after a single use. Any unused product or waste material should be disposed of in accordance with local requirements.
Shelf life:
Unopened: 3years.
Once opened, the product should be used immediately,
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