Adenosine 3 Mg/Ml Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Adenosine 3mg/ml solution for injection
Read all of this leaflet carefully before you start using 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. This includes any possible side effects not listed in this leaflet.
This product will be referred to as Adenosine solution for Injection from here on.
What is in this leaflet:
1. What Adenosine solution for injection is and what it is used for
2. What you need to know before you use Adenosine solution for injection
3. How to use Adenosine solution for injection
4. Possible side effects
5. How to store Adenosine solution for injection
6. Contents of the pack and other information
1. What Adenosine solution for injection is and what it is used for
Adenosine solution for injection contains a medicine called adenosine. This belongs to a group of medicines called ‘antiarrhythmics’.
Adenosine solution for injection works by slowing down electrical impulses between the upper and lower chambers of the heart. This slows the fast or uneven heartbeats called ‘arrhythmias’.
Adenosine solution for injection is used:
• During a test. This is to help doctors find out what type of arrhythmia (uneven heart beat) you have
• To bring your heart beat back to normal if you have a type of arrhythmia called ‘paroxysmal supraventricular tachycardia (SVT)’ or ‘Wolff-Parkinson-White Syndrome’
2. What you need to know before you use Adenosine solution for injection
Q Do not use Adenosine solution for injection if:
x You are allergic (hypersensitive) to adenosine solution for injection or any of the other ingredients of Adenosine solution for injection (listed in section 6 below).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue x You have asthma or any other severe breathing problem x You have very low blood pressure (severe hypotension) x You have heart failure where your heart is not pumping out enough blood x You have problems with your heart rhythm and do not have a pace maker (second or third degree AtrioVentricular block, sick sinus syndrome) x You have been told you have ‘Long QT syndrome’. This is a rare heart problem that can lead to a fast heart beat and fainting
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist before you are given Adenosine solution for injection.
Warnings and precautions
Talk to your doctor or nurse before using Adenosine solution for injection if:
▲ You have a certain type of unusual heart rhythm (atrial fibrillation or atrial flutter) and in particular if you have an ‘accessory conduction pathway’
▲ You have a condition called long QT syndrome (prolonged QT interval)
▲ You have low blood volume (hypovolemia) that is not adequately corrected by treatment
▲ You have problems with a part of your nervous system called the ‘autonomic nervous system’
▲ You have narrowing of the main arteries in the neck (carotid artery).
▲ You have or have ever had fits or convulsions
▲ You have difficulty in breathing (bronchospasm)
▲ You have narrowing of your heart valves (stenotic valvular heart disease)
▲ You have inflammation of the membrane surrounding your heart (pericarditis) or a buildup of fluid around your heart (pericardial effusion)
▲ You have a left-right shunt in your heart. This will mean blood goes directly from the left side of your heart to the right side
▲ You have narrowing of the left main artery supplying blood to your heart (left main coronary stenosis)
▲ You have had a recent heart attack, severe heart failure or you have had a heart transplant in the last year
▲ You have any minor problem with your heart (first degree AtrioVentricular block or bundle branch block). These conditions maybe temporarily aggravated when you are given Adenosine solution for injection
Your doctor will stop the treatment with adenosine if you experience any serious side effect.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before being given Adenosine solution for injection.
^ Other medicines and Adenosine solution for injection
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might use any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Adenosine solution for injection can affect the way some other medicines work. Also some medicines can affect the way Adenosine solution for injection works.
In particular, check with your doctor, nurse or pharmacist if you are taking any of the following:
• Dipyridamole (medicine used to thin the blood). Make sure your doctor knows you are taking dipyridamole. Your doctor may decide you should not have Adenosine solution for injection or may tell you to stop taking dipyridamole 24 hours before you are given Adenosine solution for injection or may need to give you a lower dose of Adenosine solution for injection
• Aminophylline or theophylline (medicines used to help breathing) Your doctor may tell you to stop taking it 24 hours before you are given Adenosine solution for injection
• Caffeine (sometimes found in headache medicines)
Adenosine solution for injection with food, drink and alcohol
Food and drinks containing caffeine such as tea, coffee, chocolate and cola should be avoided for at least 12 hours before you are given Adenosine solution for injection.
Pregnancy, breast-feeding and fertility
Talk to your doctor or nurse before having this medicine if:
• You are pregnant, might become pregnant, or think that you may be pregnant. You should not be given Adenosine solution for injection if you are pregnant or think you may be pregnant, unless clearly necessary
• You are breast-feeding. You should not be given Adenosine solution for injection if you are breast-feeding
Ask you doctor or nurse for advice before taking any medicine if you are pregnant or breastfeeding.
Important information about some of the ingredients of Adenosine solution for
injection
Sodium:
Adenosine solution for injection contains 3.54 mg sodium per dose (7.08 mg/2 ml vial).
This should be taken into consideration by patients on a controlled sodium diet.
3. How to use Adenosine solution for injection
How to use Adenosine solution for injection
• Adenosine solution for injection is a medicine for use in hospitals
• It will be given to you by a doctor or nurse as an injection into your vein
• Your heart and blood pressure will be closely monitored
How much Adenosine solution for injection is given
If you are not sure why you are being given Adenosine solution for injection or have any questions about how much Adenosine solution for injection is being given to you, speak to your doctor or nurse.
Adults (including the elderly)
• The first dose is 3mg given over 2 seconds. This is given by rapid injection into your vein
• If the first dose does not bring your heart beat to normal then you will be given a second dose. The second dose is 6 mg given as a rapid injection
• If the second dose does not bring your heart beat to normal then you will be given a third dose: The third dose is 12mg given as a rapid injection
• You should not have any more doses after the 12mg dose
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Over
Children
Adenosine has not been tested in children and there are only limited data.
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Healthcare Professional’s Information Leaflet
The following information is extracted from the SPC.
Technical information for the administration of Adenosine 3mg/ml solution for injection. TRADE NAME OF THE MEDICINAL PRODUCT
Adenosine 3 mg/ml solution for Injection.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6mg of adenosine per 2ml (3mg/ml).
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution free from visible particles.
Posology and method of administration
Adenosine Solution for Injection is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use.
Method of administration
It should be administered by rapid IV bolus injection according to the ascending dosage schedule below. To be certain the solution reaches the systemic circulation administer either directly into a vein or into an IV line. If given into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush.
Adenosine Solution for Injection should only be used when facilities exist for cardiac monitoring. Patients who develop high-level AV block at a particular dose should not be given further dosage increments.
Posology
Adult:
Initial dose: 3mg given as a rapid intravenous bolus (over 2 seconds).
Second dose: If the first dose does not result in elimination of the supraventricular
tachycardia within 1 to 2 minutes, 6mg should be given also as a rapid intravenous bolus.
Third dose: If the second dose does not result in elimination of the supraventricular
tachycardia within 1 to 2 minutes. 12mg should be given also as a rapid intravenous bolus.
Additional or higher doses are not recommended.
Adenosine solution for injection contains 3.54 mg sodium per dose (7.08 mg/2 ml vial).
This should be taken into consideration by patients on a controlled sodium diet.
Paediatric population:
The safety and efficacy of adenosine in children aged 0-18 years old have not been established. No data are available. No controlled paediatric study has been undertaken.
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Ove
If you use more Adenosine solution for injection than you should
As this medicine is given to you by a doctor or nurse it is unlikely that you will be given more than you require. Your doctor will carefully work out how much Adenosine solution for injection you should be given.
If you have more of this medicine than you should, the following effects may happen:
• Very low blood pressure (severe hypotension)
• Slow heartbeat (bradycardia)
• A heart problem (asystole)
Your doctor will be monitoring your heart throughout the procedure.
As the length of time adenosine stays in the blood is very short, any side effects of Adenosine solution for injection would quickly stop when the injection is stopped.
Sometimes you may need an injection of a medicine called aminophylline or theophylline to help with any side effects.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist
4. Possible side effects
Like all medicines, Adenosine solution for injection can cause side effects, although not everybody gets them. While you are being given Adenosine solution for injection you may have some of the following side effects:
The side effects normally settle within seconds or minutes after the injection is finished but you should tell your doctor or nurse if any of them happen.
If any of the following side effects get worse, tell your doctor or nurse and they may stop the injection:
Very common
(affects more than 1 person in 10)
• Reddening of skin with a feeling of heat (flushing)
• Slow heartbeat (bradycardia)
• Skipped heart beats or extra heartbeats
• A heart problem called an AV block
• Severe heart problems which can be fatal (asystole) or uneven heartbeat
• Shortness of breath or the urge to breathe deeply (dyspnoea)
• Chest pain or pressure on the chest
Common
(affects less than 1 person in 10)
• Feeling dizzy or light-headed
• Feeling sick (nausea)
• Headache
• Unusual skin sensations such as burning
• Feeling nervous
Uncommon
(affects less than 1 person in 100)
• Blurred vision
• Being aware of your heartbeat or feeling it ‘racing’
• Metallic taste in your mouth
• Breathing more quickly or more deeply than normal (hyperventilation)
• Rise in the pressure inside the skull
• Feeling of general discomfort, weakness or pain
• Sweating
Very rare
(affects less than 1 person in 10 000)
• Severe breathlessness or problems in breathing
• Redness, pain or swelling at the site of injection
• Feeling uncomfortable during the injection
• Worsening of high blood pressure that affects the brain (intracranial hypertension)
• Very slow, fast or uneven heartbeats
• Very slow heart beat (severe bradycardia)
Other side effects
(frequency cannot be estimated from the available data)
• Severe heart problems which can be fatal (asystole) or uneven heartbeat
• Fainting
• Fits (convulsions)
• Being sick (vomiting)
• Stopping breathing (respiratory arrest)
If any of the above side effects get worse, tell your doctor or nurse and they may stop the injection.
The side effects normally settle within seconds or minutes after the injection is finished but you should tell your doctor or nurse if any of them happen.
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 via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Adenosine solution for injection
This medicine will be kept by your doctor, nurse or pharmacist in a safe place where children cannot see or reach it.
Adenosine solution for injection should not be used after the expiry date which is stated on the carton and on the label.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
The product is for single use only and should be used straight away after opening. Any portion of the vial not used at once should be disposed of.
Adenosine solution for injection should not be used if your doctor or nurse notice any particles in the solution or any discolouration before they give you the medicine.
If the appearance of the medicine has changed, the vial must be thrown away.
Medicines should not be disposed of via wastewater or household waste. The pharmacist will dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Adenosine solution for injection contains
• The active substance is adenosine. Each 2ml vial of Adenosine solution for injection contains 6mg of adenosine (3 mg per ml).
• The other ingredients are sodium chloride and water for injections.
What Adenosine solution for injection looks like and contents of the pack
Adenosine solution for injection is a clear, colourless solution for injection.
Each pack contains 6 vials.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd,
Capital House,
85 King William Street,
London EC4N 7BL,
UK
Manufacturer:
VALDEPHARM Parc Industriel d’incarville 27106 Val de Reuil France
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or nurse.
This leaflet was last revised in November 2014.
101939/LF/147/04
005U2054103
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Published uncontrolled studies show similar effects of adenosine in adults and children: effective doses for children were between 0.0375 and 0.25mg/kg.
Elderly:
See dosage recommendations for adults.
Diagnostic dose
The above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained.
Method of administration: Rapid intravenous injection only.
PHARMACEUTICAL PARTICULARS List of excipients Sodium Chloride Water for Injection Incompatibilities
Compatibility with other medicines is not known.
Shelf life
24 months.
Any portion of the vial not used at once should be discarded.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Clear, type I glass vials with chlorobutyl rubber stoppers secured with aluminium caps with flip-off seals.
Pack of 6 vials in a plastic tray.
Special precautions for disposal and handling
None.
MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd,
Capital House, 85 King William Street, London EC4N 7BL, UK MARKETING AUTHORISATION NUMBER
PL 12762/0470
101939/HPL/147/04
005U2054103