Adenosine 3mg/ml solution for injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

ADENOSINE

Tilgjengelig fra:

Wockhardt UK Limited

ATC-kode:

C01EB; C01EB10

INN (International Name):

ADENOSINE

Dosering :

3 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Other cardiac preparations; adenosine

Autorisasjon status:

Marketed

Autorisasjon dato:

2013-10-04

Informasjon til brukeren

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.
WHAT IS IN THIS LEAFLET:
1. What Adenosine Injection and what it is used for
2. What you need to know 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. Contents of the pack and other 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 thi

Preparatomtale

Health Products Regulatory Authority
16 September 2019
CRN0090YW
Page 1 of 7
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).
Excipient(s) with known effect
Each 2ml vial contains 7.08 mg (3.56mg/ml) of sodium equivalent to
0.3mmol (0.15mmol/ml) of 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
Adenosine is intended for hospital use only with monitoring and
cardiorespiratory resuscitation equipment available for
immediate use.
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.
Adenosine is intended for use with continuous monitoring and ECG
recording
during administration.
Patients who