Adenosine Injection USP 12mg/4ml Taj Pharma

Adenosine Injection USP 12mg/4ml

1. Name of the medicinal product

Adenosine Solution for injection USP 6mg/2ml Taj Pharma
Adenosine Solution for injection USP 12mg/4ml Taj Pharma

2. Qualitative and quantitative compositions

Each vial contains 6 mg of adenosine per 2 ml (3 mg/ml).
Each vial contains 12 mg of adenosine per 4 ml (3 mg/ml).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection

4. Clinical particulars

4.1 Therapeutic indications

Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory by-pass tracts (Wolff-Parkinson-White Syndrome).

Paediatric population

Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardia in children aged 0 to 18 years.

Diagnostic indications

Aid to diagnosis of broad or narrow complex supraventricular tachycardias. Although Adenosine will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity.

Sensitisation of intra-cavitary electrophysiological investigations.

4.2 Posology and method of administration

Adenosine 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 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:

Additional or higher doses are not recommended.

Paediatric population

During administration of adenosine cardio-respiratory resuscitation equipment must be available for immediate use if necessary.

Adenosine is intended for use with continuous monitoring and ECG recording during administration.

The dosing recommended for the treatment of paroxysmal supraventricular tachycardia in the paediatric population is:

– First bolus of 0.1 mg/kg body weight (maximum dose of 6 mg)

– Increments of 0.1 mg/kg body weight as needed to achieve termination of supraventricular tachycardia (maximum dose of 12 mg).

Method of administration

Adenosine should be administered by rapid intravenous (IV) bolus injection into a vein or into an IV line. If given into an IV line it should be injected through as proximally as possible, and followed by a rapid saline flush. If administered through a peripheral vein, a large bore cannula should be used.

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.

4.3 Contraindications

Adenosine is contraindicated for patients presenting:

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Sick sinus syndrome, second or third degree Atrio-Ventricular (AV) block (except in patients with a functioning artificial pacemaker).
• Chronic obstructive lung disease with evidence of bronchospasm (e.g. asthma bronchiale)
• Long QT syndrome
• Severe hypotension
• Decompensated states of heart failure

4.4 Special warnings and precautions for use

Special warnings

Due to the possibility of transient cardiac arrhythmias arising during conversion of the supraventricular tachycardia to normal sinus rhythm, administration should be carried out in a hospital setting with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary. During administration, continuous ECG monitoring is necessary as life-threatening arrhythmia might occur (see section 4.2).

Because it has the potential to cause significant hypotension, adenosine should be used with caution in patients with left main coronary stenosis, uncorrected hypovolemia, stenotic valvular heart disease, left to right shunt, pericarditis or pericardial effusion, autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency. There have been reports of cerebrovascular accident/transient ischemic attack, secondary to the haemodynamic effects of adenosine.

There have been reports of myocardial infarction shortly after use of Adenosine . Adenosine should be used with caution in patients with recent myocardial infarction, severe heart failure, or in patients with minor conduction defects (first degree A-V block, bundle branch block) that could be transiently aggravated during infusion.

Adenosine should be used with caution in patients with atrial fibrillation or flutter and especially in those with an accessory by-pass tract since particularly the latter may develop increased conduction down the anomalous pathway.

Rare cases of severe bradycardia have been reported. Some occurred in early post heart transplant patients; in the other cases, occult sino-atrial disease was present. The occurrence of severe bradycardia should be taken as a warning of underlying disease and could potentially favour the occurrence of torsades de pointes, especially in patients with prolonged QT intervals.

In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed.

Since neither the kidney nor the liver are involved in the degradation of exogenous adenosine, Adenosine ‘s efficacy should be unaffected by hepatic or renal insufficiency.

As dipyridamole is a known inhibitor of adenosine uptake, it may potentiate the action of Adenosine. It is therefore suggested that Adenosine should not be administered to patients receiving dipyridamole; if use of Adenosine is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenosine should be greatly reduced (see section 4.5).

Precautions

The occurrence of angina, severe bradycardia, severe hypotension, respiratory failure (potentially fatal), or asystole/cardiac arrest (potentially fatal), should lead to immediate discontinuation of administration.

Adenosine may trigger convulsions in patients who are susceptible to convulsions. In patients with history of convulsions/seizures, the administration of adenosine should be carefully monitored.

Because of the possible risk of torsades de pointes, Adenosine should be used with caution in patients with a prolonged QT interval, whether this is drug induced or of metabolic origin. Adenosine is contraindicated in patients with Long QT syndrome (see section 4.3).

Adenosine may precipitate or aggravate bronchospasm (see sections 4.3 and 4.8).

Adenosine contains 9 mg sodium chloride per ml (corresponding to 3.54 mg sodium per ml). To be taken into consideration by patients on a controlled sodium diet.

Paediatric population

Adenosine may trigger atrial arrhythmias and thus might lead to ventricular acceleration in children with Wolff-Parkinson-White (WPW) syndrome (see section 5.1).

The efficacy of intraosseus administration has not been established.

4.5 Interaction with other medicinal products and other forms of interaction

Dipyridamole inhibits adenosine cellular uptake and metabolism, and potentiates the action of adenosine. In one study dipyridamole was shown to produce a 4 fold increase in adenosine actions. Asystole has been reported following concomitant administration.

It is therefore suggested that Adenosine should not be administered to patients receiving dipyridamole; if use of Adenosine is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenosine should be greatly reduced (see section 4.4).

Aminophylline, theophylline and other xanthines are competitive adenosine antagonists and should be avoided for 24 hours prior to use of adenosine.

Food and drinks containing xanthines (tea, coffee, chocolate and cola) should be avoided for at least 12 hours prior to use of adenosine.

Adenosine may interact with drugs tending to impair cardiac conduction.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of adenosine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Adenosine is not recommended during pregnancy unless the physician considers the benefits to outweigh the potential risks.

Breast-feeding

It is unknown whether adenosine metabolites are excreted in human milk. Adenosine should not be used during breast-feeding.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

These side effects are generally mild, of short duration (usually less than 1 minute) and well tolerated by the patient. However severe reactions can occur.

Methylxanthines, such as IV aminophylline or theophylline have been used to terminate persistent side effects (50 – 125 mg by slow intravenous injection).

Adverse events are ranked under the heading of the frequency: Very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/10000), not known (cannot be estimated from available data).

Immune system disorders:

Not known: anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash).

Cardiac disorders:

Very common: bradycardia, sinus pause, skipped beats, atrial extrasystoles, Atrio-Ventricular block, ventricular excitability disorders such as ventricular extrasystoles, non-sustained ventricular tachycardia

Uncommon: sinus tachycardia, palpitations

Very rare: atrial fibrillation, severe bradycardia not corrected by atropine and possibly requiring temporary pacing, ventricular excitability disorders, including ventricular fibrillation and torsade de pointes (see section 4.4)

Not known: asystole/cardiac arrest, sometimes fatal especially in patients with underlying ischemic heart disease/cardiac disorder (see section 4.4)

Vascular disorders:

Very common: flushing

Not known: hypotension (sometimes severe) (see section 4.4)

Nervous system disorders:

Common: headache, dizziness, light-headedness, paraesthesia

Uncommon: head pressure

Very rare: transient and spontaneously rapidly reversible worsening of intracranial hypertension

Not known: loss of consciousness/syncope, convulsions, especially in predisposed patients (see section 4.4)

Eye disorders:

Uncommon: blurred vision

Respiratory, thoracic and mediastinal disorders:

Very common: dyspnea (or the urge to take a deep breath)

Uncommon: hyperventilation

Very rare: bronchospasm (see section 4.4)

Not known: respiratory failure (see section 4.4), apnea/respiratory arrest

Cases of respiratory failure, bronchospasm, apnea, and respiratory arrest with fatal outcome have been reported.

Gastrointestinal disorders:

Common: nausea

Uncommon: metallic taste

Not known: vomiting

Psychiatric disorders:

Common: nervousness

General disorders and administration site conditions:

Very common: chest pain or pressure, feeling of thoracic constriction/oppression

Uncommon: sweating, discomfort in the leg, arm or back, feeling of general discomfort, weakness/pain

Very rare: injection site reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product

4.9 Overdose

Overdose would cause severe hypotension, bradycardia or asystole. The half-life of adenosine in blood is very short, and side effects (when they occur) would quickly resolve. Administration of IV aminophylline or theophylline may be needed. Pharmacokinetic evaluation indicates that methyl xanthines are competitive antagonists to adenosine, and that therapeutic concentrations of theophylline block its exogenous effects.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other Cardiac Preparations

Endogenous nucleoside with peripheral vasodilator/antiarrhythmic effect; antiarrhythmic drug.

Adenosine is a purine nucleoside which is present in all cells of the body. Animal pharmacology studies have in several species shown that Adenosine has a negative dromotropic effect on the atrioventricular (AV) node.

In man, Adenosine (adenosine) administered by rapid intravenous injection slows conduction through the AV node. This action can interrupt re-entry circuits involving the AV node and restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardias. Once the circuit has been interrupted, the tachycardia stops and normal sinus rhythm is re-established.

One acute interruption of the circuit is usually sufficient to arrest the tachycardia.

Since atrial fibrillation and atrial flutter do not involve the AV node as part of a re-entry circuit, Adenosine will not terminate these arrhythmias.

By transiently slowing AV conduction, atrial activity is easier to evaluate from ECG recordings and therefore the use of Adenosine can aid the diagnosis of broad or narrow complex tachycardias.

Adenosine may be useful during electrophysiological studies to determine the site of AV block or to determine in some cases of pre-excitation, whether conduction is occurring by an accessory pathway or via the AV node.

Paediatric population

No controlled studies have been conducted in paediatric patients with adenosine for the conversion of paroxysmal supraventricular tachycardia (PSVT). However, the safety and efficacy of adenosine in children aged 0 – 18 years with PSVT is considered established based on extensive clinical use and literature data (open label studies, case reports, clinical guidelines).

Literature review identified 14 studies where IV adenosine was used for acute termination of supraventricular tachycardia (SVT) in around a total of 450 paediatric patients aged 6 hours – 18 years. Studies were heterogenic in terms of age, and dosing schedules. SVT was terminated in 72 – 100% of cases in most of the published studies. Dosages used varied from 37.5 mcg/kg to 400 mcg/kg. Several studies discussed a lack of response to starting doses less than 100 mcg/kg.

Depending on the child’s clinical history, symptoms and ECG diagnosis, adenosine has been used in clinical practice under expert supervision in children with stable wide-QRS complex tachycardia and Wolff-Parkinson-White syndrome however the currently available data does not support a paediatric indication. In total 6 cases of adenosine-induced arrhythmias (3 atrial fibrillation, 2 atrial flutter, 1 ventricular fibrillation) have been described in 6 children aged 0 – 16 years with manifest or concealed WPW syndrome, of which 3 spontaneously recovered and 3 needed amiodarone +/- cardioversion (see section 4.4).

Adenosine has been used as an aid to diagnosis of broad or narrow complex supraventricular tachycardias in same doses as for treatment of supraventricular tachycardia. Although adenosine will not convert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. However, the currently available data does not support a paediatric indication for the use of adenosine for diagnostic purposes.

5.2 Pharmacokinetic properties

Adenosine is impossible to study via classical ADME protocols. It is present in various forms in all cells of the body where it plays an important role in energy production and utilisation systems. An efficient salvage and recycling system exists in the body, primarily in the erythrocytes and blood vessel endothelial cells. The half-life in vitro is estimated to be < 10 seconds. The in vivo half-life may be even shorter.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars

6.1 List of excipients

Sodium Chloride

Water for Injections

6.2 Incompatibilities

Compatibility with other medicines is not known.

6.3 Shelf life

3 years.

Any portion of the vial not used at once should be discarded.

6.4 Special precautions for storage

Do not refrigerate.

6.5 Nature and contents of container

Clear, type I glass vials with chlorobutyl rubber closures secured with aluminium caps. Packs of 6 vials in plastic trays in cardboard cartons.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India by:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Adenosine Injection USP 6mg/2ml, 12mg/4ml

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adenosine 6mg/2ml, 12mg/4ml solution for injection Taj Pharma

Adenosine

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 possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

Adenosine contains a medicine called adenosine. This belongs to a group of medicines called ‘antiarrhythmics’.

Adenosine 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 is used:

• During a test. This is to help doctors find out what type of arrhythmia (uneven heart beats) 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’.

In children, Adenosine bolus is used:

• To bring your child’s heart beat back to normal if your child have a type of heart rhythm trouble called ‘paroxysmal supraventricular tachycardia’ (PSVT).

2. What you need to know before you are given Adenosine

Do not have this medicine and tell your doctor if:

• You are allergic to adenosine or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You have asthma or any other severe breathing problem.
• You have very low blood pressure (severe hypotension).
• You have a type of heart failure where your heart is not pumping out enough blood.
• You have problems with your heart rhythm and do not have a pace maker (second or third degree AtrioVentricular block, sick sinus syndrome).
• 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 .

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you have Adenosine 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 been told that you have a heart problem whereby the electrical impulses in parts of your heart take longer than normal to discharge and then recharge (prolonged QT interval).
• You have low blood volume (hypovolaemia) that is not adequately corrected by treatment with medicines.
• 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). This means that not enough blood is getting to the brain (cerebrovascular insufficiency).
• 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 build-up 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 may be temporarily aggravated when you are given Adenosine .

If you get a very slow heartbeat (severe bradycardia), respiratory failure, a heart problem that can be fatal (asystole), severe chest pains (angina) or very low blood pressure (severe hypotension), then treatment with Adenosine should be stopped.

Talk to your doctor immediately if:

• You experience signs of stroke. This may present itself as a sudden numb or weak feeling in the face, arms, or legs. Other signs include feeling confused, problems with sight, walking, coordination or balance, problems in saying words or slurring of speech.
• You experience signs of heart attack (myocardial infarction). Severe chest pain is the usual main symptom. The pain may also travel up into your jaw, and down your left arm, or down both arms. You may also sweat, feel sick, and feel faint. A small heart attack (myocardial infarction) occasionally happens without causing pain (a ‘silent myocardial infarction’). It may be truly pain-free, or sometimes the pain is mild and you may think it is just heartburn or ‘wind’.

Children and adolescents

In children with a heart rhythm trouble called ‘Wolff-Parkinson-White (WPW) syndrome’, Adenosine bolus may cause some unexpected severely abnormal heart rhythm.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before being given Adenosine .

Other medicines and Adenosine

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Adenosine can affect the way some other medicines work. Also some medicines can affect the way Adenosine 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 or may tell you to stop taking dipyridamole 24 hours before you are given Adenosine or may need to give you a lower dose of Adenosine .
• Aminophylline or theophylline (medicines used to help breathing) Your doctor may tell you to stop taking it 24 hours before you are given Adenosine .
• Caffeine (sometimes found in headache medicines).

Adenosine with food and drink

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 .

Pregnancy and breast-feeding

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 if you are pregnant or think you may be pregnant, unless clearly necessary
• You are breast-feeding. You should not be given Adenosine if you are breast-feeding

Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breast-feeding.

Adenosine injection contains 3.54mg sodium per dose (7.08mg/2ml vial).

This should be taken into consideration by patients on a controlled sodium diet.

3. How Adenosine is given

How Adenosine is given

• Adenosine 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 is given

If you are not sure why you are being given Adenosine or have any questions about how much Adenosine is being given to you, speak to your doctor, nurse or pharmacist.

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 6mg 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.

Children and adolescents

Adenosine bolus is a medicine for use in hospitals with resuscitation equipment available.

Your doctor will decide if this medicine is needed, how much should be given depending on your child’s weight, and if several injections are needed.

• Your child will be closely monitored, including recording of his/her heart’s electrical activity using an ECG (electrocardiogram) machine.
• It will be given as an injection into your child vein by a doctor or nurse.

If you have more Adenosine than you should

As this medicine is given to you by a doctor or nurse it is unlikely that you will be given too much. Your doctor will carefully work out how much Adenosine 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 too much Adenosine 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 can cause side effects, although not everybody gets them. While you are being given Adenosine you may have some of the following side effects:

If any of the following 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.

Very common (may affect more than 1 in 10 people)

• 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 (may affect less than 1 in 10 people)

• Feeling dizzy or light-headed
• Feeling sick (nausea)
• Headache
• Unusual skin sensations such as burning
• Feeling nervous

Uncommon (may affect less than 1 in 100 people)

• 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)
• Feeling pressure in your head, or weighed down in your arms
• Feeling of general discomfort, weakness or pain
• Sweating

Very rare (may affect less than 1 in 10,000 people)

• 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
• Severe bradycardia (very slow heartbeat)

Other side effects

• Allergic reactions including swelling of the face or throat, and skin reactions such as hives or rash
• 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Adenosine

This medicine will be kept by your doctor or nurse in a safe place where children cannot see or reach it.

Adenosine should not be used after the expiry date which is stated on the carton and on the label after ‘EXP’.

The expiry date refers to the last day of that month.

Adenosine should not be refrigerated.

The medicine 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 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.

Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.

6. Contents of the pack and other information

What Adenosine contains

• The active substance is adenosine. Each 2ml vial of Adenosine contains 6mg of adenosine (3mg per ml).
• The other ingredients are sodium chloride and water for injections.

What Adenosine looks like and contents of the pack

Adenosine is a clear, colourless solution for injection.

Each pack contains 6 vials.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com