Adenocor 3 mg/ml solution for injection

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Adenosine

Διαθέσιμο από:

Sanofi-Aventis Ireland Limited T/A SANOFI

Φαρμακολογική κατηγορία (ATC):

C01EB; C01EB10

INN (Διεθνής Όνομα):

Adenosine

Δοσολογία:

3 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Other cardiac preparations; adenosine

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1994-06-16

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ADENOCOR® 3MG/ML SOLUTION FOR INJECTION
ADENOSINE
SANOFI
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE.
• Keep this leaflet. You may need to read it again
• If you have any further questions after reading this leaflet, ask
your doctor
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist
IN THIS LEAFLET:
1. What Adenocor is and what it is used for
2. What you need to know before you are given Adenocor
3. How Adenocor is given
4. Possible side effects
5. How to store Adenocor
6. Contents of the pack and other information
1.
WHAT ADENOCOR IS AND WHAT IT IS USED FOR
Adenocor contains a medicine called adenosine. This belongs to a group
of medicines called
‘antiarrythmics’. Adenocor works by slowing down electrical
impulses between the upper and lower
chambers of the heart. This slows the fast or uneven heartbeats called
‘arrythmias’.
ADENOCOR IS USED:
ADULTS
• During a test. This is to help doctors find out what type of
arrythmia (uneven heartbeat) you have
• To bring your heart beat back to normal if you have a type of
arrythmia called ‘paroxysmal
supraventricular tachycardia (SVT)’ or ‘Wolf-Parkinson-White
Syndrome
Children:
• To bring your childs heart back to normal if your child has a type
of heart rhythm trouble called
'paroxysmal supraventricular tachycardia' (PSVT).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ADENOCOR
Do not have this medicine and tell your doctor if:
• You are allergic (hypersensitive) to adenosine or any of the other
ingredients of Adenocor (listed in
section 6 below). 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
• You have asthma
• You have been told you have ‘Long QT syndrome’

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
12 October 2023
CRN00DRW1
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adenocor 3 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6mg of adenosine per 2ml (3mg/ml).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
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 Adenocor 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.
Paediatric population
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular tachycardia in children aged 0 to 18 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adenocor is intended for hospital use only with monitoring and
cardiorespiratory resuscitation equipment available for
immediate use. 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.
Adenocor 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.
THERAPEUTIC DOSE
Adult:
Initial dose: 3mg given as a rapid intravenous bolus (injection over 2
seconds).
Second dose: If the first dose does not result in elimination of the
supraventricular tachycardia within 1 to 2 minutes, 6mg