Adenosine 3 mg/ml solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Adenosine

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

C01EB; C01EB10

INN (International Name):

Adenosine

Dosage:

3 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

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

Therapeutic area:

Other cardiac preparations; adenosine

Authorization status:

Marketed

Authorization date:

2015-08-28

Patient Information leaflet

Adenosine-UK-IE-PIL-VAR 008
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ADENOSINE 3 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
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 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 use Adenosine
3. How to use Adenosine
4. Possible side effects
5. How to store Adenosine
6. Contents of the pack and other information
1. 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 in adults:
• During a test. This is to help doctors find out what type of
arrhythmia (uneven
heartbeat) 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
DO NOT USE ADENOSINE 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 problems with your heart rhythm and do not have a pacemaker
(second or
third degree atrioventricular block, sick sinus syndrome)
- you have very low blood pressure (severe hypotension)
- you have asthma or any other severe breathing problem
- you have a type of heart failure where your heart is not pumping out
enough blood
Adenos

Summary of Product characteristics

Health Products Regulatory Authority
13 February 2024
CRN00DRL8
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adenosine 3 mg/ml solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 3 mg of adenosine.
Each 1 ml single dose pre-filled syringe contains 3 mg of adenosine.
Each 2 ml single dose pre-filled syringe contains 6 mg of adenosine.
Each 4 ml single dose pre-filled syringe contains 12 mg of adenosine.
Each 1 ml of solution contains 3.54 mg (0.15 mmoL) of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Clear, colourless solution.
pH: 5.5 – 7.5
Osmolality: 270 – 330 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_For adults only:_
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular tachycardias, including those associated with
accessory by-pass tracts (Wolff-Parkinson-White Syndrome).
_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.
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:_
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
s