Adenosine 30mg/10ml Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Adenosine 30 mg/10 ml Solution for Infusion
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 Infusion from here on.
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 use Adenosine solution for infusion
3. How to use Adenosine solution for infusion
4. Possible side effects
5. How to store Adenosine solution for infusion
6. Contents of the pack and other information
1. What Adenosine solution for infusion is and what it is used for
Adenosine solution for infusion contains a medicine called adenosine. This belongs to a group of medicines called ‘coronary vasodilatators’.
This medicine is for diagnostic use only.
Adenosine solution for infusion is used before a test called “myocardial perfusion imaging” to look at your heart. During his test you are given a medicine called a radiopharmaceutical”. Adenosine solution for infusion works by opening up your heart’s blood vessels and allowing blood to flow more freely. This allows the “radiopharmaceutical” medicine to get into your heart. The doctor can see your heart and assess your heart condition. This procedure is used if you are unable to exercise due to disability or if an exercise stress test is not possible.
2. What you need to know before you use Adenosine solution for infusion
Q Do not use Adenosine solution for infusion if:
x You are allergic (hypersensitive) to adenosine or any of the other ingredients of Adenosine solution for infusion (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 very low blood pressure (severe hypotension) x You have unstable angina which is not controlled by treatment with medicine x You have asthma or any other severe breathing problem x You are taking a medicine called dipyridamole used to thin the blood. 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 or nurse before you are given Adenosine solution for infusion.
Q Warnings and precautions
Talk to your doctor or nurse before using Adenosine solution for infusion if:
▲ You have low blood volume (hypovolaemia) 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 heart disease due to 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 an ‘accessory conduction pathway’
▲ You have first degree AtrioVentricular block or bundle branch block. These conditions may be temporarily aggravated when you are given Adenosine solution for infusion
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 infusion.
ES Other medicines and Adenosine solution for infusion
Please tell your doctor or nurse 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 infusion can affect the way some other medicines work. Also some medicines can affect the way Adenosine solution for infusion works.
In particular, check with your doctor or nurse 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 tell you to stop taking dipyridamole 24 hours before you are given Adenosine solution for infusion or you may be given a much lower dose of Adenosine solution for infusion
• Aminophylline, theophylline or other xanthines (medicines used to help breathing). Your doctor may tell you to stop taking it 24 hours before you are given Adenosine solution for infusion
Adenosine solution for infusion with food, drink and alcohol
Food and drinks containing xanthines such as tea, coffee, chocolate and cola should be avoided for at least 12 hours before you are given Adenosine solution for infusion.
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 infusion unless clearly necessary
• You are breast-feeding. You should not be given Adenosine solution for infusion.
Ask you doctor or nurse for advise before taking any medicine if you are pregnant or breastfeeding.
Important information about some of the ingredients of Adenosine solution for infusion
Sodium: Adenosine solution for infusion contains 35.4 mg sodium per infusion vial (10 ml). You may receive up to 0.99 mg of sodium per kilogram of body weight.This should be taken into consideration by patients on a controlled sodium diet.
3. How to use Adenosine solution for infusion
How to use Adenosine solution for infusion
• Adenosine solution for infusion is a medicine for use in hospitals
• It will be given to you by a doctor or nurse as an injection. The injection will be into one of your veins and be given over a period of time (this is called an intravenous infusion)
• Your heart and blood pressure will be closely monitored
How much Adenosine solution for infusion is given
If you are not sure why you are being given Adenosine solution for infusion or have any questions about how much Adenosine solution for infusion is being given to you, speak to your doctor or nurse.
Adults (including the elderly)
• The dose is calculated according to your weight
• The usual dose is 140 micrograms per kilogram of body weight, per minute. This is given over a period of six minutes through an infusion pump (a slow injection into a vein)
• The dose of Adenosine solution for infusion is not changed if you have liver or kidney problems
Use in children and adolescents If you are below 18 years of age
Adenosine solution for infusion has not been studied in children and adolescents.
If you use more Adenosine solution for infusion 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 infusion you should be given.
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HEALTHCARE PROFESSIONAL’S INFORMATION LEAFLET
The following information is extracted from the SPC.
Technical Information for the administration of Adenosine 30mg/10ml solution for Infusion.
TRADE NAME OF THE MEDICINAL PRODUCT
Adenosine 30 mg/10 ml Solution for Infusion.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml vial of Adenosine Solution for Infusion contains 30 mg of adenosine (3 mg/ml)
PHARMACEUTICAL FORM
Solution for infusion.
Adenosine Solution for Infusion is a sterile clear, colourless solution, free from visible particles. Posology and method of administration
Adenosine Solution for Infusion is intended for use in hospitals with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary.
It should be administered following the same procedure as for exercise testing where facilities for cardiac monitoring and cardio-respiratory resuscitation are available. During administration of Adenosine Solution for Infusion continuous ECG control is necessary as life-threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute.
Adults :
1. Adenosine Solution for Infusion should be administered undiluted as a continuous peripheral intravenous infusion at a dose of 140 /jg/kg/min for six minutes using an infusion pump. Separate venous sites for Adenosine Solution for Infusion and radionuclide administration are recommended to avoid an adenosine bolus effect.
2. After three minutes of Adenosine 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 Adenosine Solution for Infusion.
3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the Adenosine Solution for Infusion.
4. Adenosine solution for infusion contains 35.4 mg sodium per infusion vial (10 ml).
This should be taken into consideration by patients on a controlled sodium diet.
The table below is given as a guide for adjustment of the infusion rate of undiluted Adenosine Solution for Infusion, in line with bodyweight (total dose 0.84 mg/kg).
|
Patient 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 |
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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 solution for infusion stays in the blood is very short, any side effects of Adenosine solution for infusion would quickly stop when the infusion 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 or nurse.
4. Possible side effects
Like all medicines, Adenosine solution for infusion can cause side effects, although not everybody gets them. While you are being given Adenosine solution for infusion 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 immediately and they will decide if you should continue the infusion or not:
Very common (affects more than 1 user in 10)
• Reddening of skin with a feeling of heat (flushing)
• Shortness of breath or the urge to breathe deeply (dyspnoea)
• Headache
• Chest pain or pressure on the chest
• Abdominal discomfort
Common (affects less than 1 user in 10)
• Feeling dizzy or light-headed
• Unusual skin sensations such as numbness, tingling, prickling, burning or creeping on the skin (paraesthesia)
• Low blood pressure
• A heart problem called an AtrioVentricular block
• Fast or irregular heartbeat (disorders of cardiac rhythm)
• Dry mouth
• Discomfort in throat, jaw or neck
Uncommon (affects less than 1 user in 100)
• Metallic taste in your mouth
• Sweating
• Discomfort in leg, arm or back
• Feeling of weakness or pain, or of general discomfort
• Feeling nervous
• Slow heartbeat (bradycardia)
Rare (affects less than 1 user in 1000)
• Difficulty in breathing (bronchospasm)
• Blocked nose
• Feeling drowsy
• Blurred vision
• Ringing in the ear (tinnitus)
• Feeling a sudden need to urinate
• Nipple discomfort
• Tremors
Very rare (affects less than 1 user in 10 000)
• Severe breathlessness or problem in breathing
• Redness, pain or swelling at the site of injection
Other side effects (frequency cannot be estimated from the available data)
• Severe heart problems which can be fatal (asystole) or uneven heartbeat
• Fits (convulsions)
• Fainting
• Stopping breathing (respiratory arrest)
• Feeling sick (nausea) or being sick (vomiting)
If any of the above side effects get worse, tell your doctor or nurse immediately and they will decide if you should continue the infusion or not. The side effects normally settle within seconds or minutes after the infusion 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 infusion
This medicine will be kept by your doctor or nurse or pharmacist in a safe place where children cannot see or reach it.
Adenosine solution for infusion 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 infusion 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. These measures will help to protect the environment.
6. Content of the pack and other information
What Adenosine solution for infusion contains
• The active substance is adenosine. Each 10 ml vial of Adenosine solution for infusion contains 30 mg of adenosine (3 mg per ml).
• The other ingredients are sodium chloride and sterile water for injections.
What Adenosine solution for infusion looks like and contents of the pack
Adenosine solution for infusion is a clear, sterile, colourless solution for infusion.
Each pack contains 6 single use vials of 30 mg/10 ml.
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 was last revised in December 2013.
101940/LF/3
005U2055103
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Patient Weight (kg) Infusion Rate (ml/min)
Paediatric population:
The safety and efficacy of adenosine in children aged 0-18 years old have not been established. No data are available.
Elderly:
See dosage recommendations for adults.
PHARMACEUTICAL PARTICULARS
List of excipients
Sodium Chloride Water for Injection Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
The shelf life of the unopened product is 24 months.
The product should be used immediately after opening.
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
The product is for single use only.
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.
Any unused product or waste material should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Mercury Pharmaceuticals Ltd,
Capital House, 85 King William Street, London EC4N 7BL, UK
MARKETING AUTHORISATION NUMBER
101940/HPL/3
005U2055103
PL 12762/0471