ADENOSINE 3 Mg/Ml Solution for Injection

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

ADENOSINE

Saadav alates:

Fresenius Kabi Limited

ATC kood:

C01EB10

INN (Rahvusvaheline Nimetus):

ADENOSINE

Annus:

3 Mg/Ml

Ravimvorm:

Solution for Injection

Retsepti tüüp:

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

Terapeutiline ala:

Other cardiac preparations

Volitamisolek:

Authorised

Loa andmise kuupäev:

2015-08-28

Infovoldik

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)
-

Toote omadused

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.
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