Adenosine Solution for Injection 3mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ADENOSINE

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

C01EB10

INN (International Name):

ADENOSINE 3 mg

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ADENOSINE 3 mg

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Withdrawn

Authorization date:

2017-11-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ADENOSINE 3MG/ML SOLUTION FOR INJECTION (6MG IN 2ML)
(Referred to as Adenosine Injection in the remainder of the leaflet)
Read all of this leaflet carefully before you start to take this
medicine

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist

This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours

If any of the side effects get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
I
N THIS LEAFLET:
1. What Adenosine Injection and what it is used for
2. Before you are given Adenosine Injection
3. How you will be given Adenosine Injection
4. Possible side effects
5. How to store Adenosine Injection
6. Further information
1. WHAT ADENOSINE INFUSION IS AND WHAADENOSINE INFUSION IS AND
WHAT IT ISUSED FOR
1. WHAT ADENOSINE INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Adenosine Injection. The active
ingredient in your medicine is
adenosine. Adenosine belongs to a group of medicines called
antiarrhythmics.
Adenosine Injection works by slowing down electrical impulse between
the upper and lower
chambers of the heart. This slows the fast or uneven heartbeat called
arrhythmias.
Adenosine Injection is used:

during a test. This helps doctors find out what type of arrhythmia
(uneven heartbeat)
you have

to bring your heart back to normal if you have a type of arrhythmia
called
paroxysmal supraventricular tachycardia (PSVT) or Wolff
Parkinson-White
Syndrome (WPW)
In children, Adenosine Injection bolus is used:

To bring your child’s heart beat back to normal if your child have a
type of heart
rhythm trouble called PSVT.
2. BEFORE YOU ARE GIVEN ADENOSINE INJECTION
DO NOT TAKE ADENOSINE INJECTION IF YOU

are allergic (hypersensitive) to adenosine or to any of the other
ingredients in this
medicine (see section 6. Further info

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Adenosine 3mg/ml Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6mg of adenosine per 2ml (3mg/ml).
Contains sodium.
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection (injection).
A clear, colourless solution free from visible particles.
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 injection 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
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.
During administration of adenosine cardio-respiratory resuscitation
equipment
must be available for immediate use if necessary.
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Adenosine is intended for use with continuous monitoring and ECG
recording
during administration.
Patients who develop high-level AV block at a particular dose should
not be given
further dosage increments.
POSOLOGY
ADULTS:
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