Adenosine 3mg/ml Solution for Injection

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

ADENOSINE

Disponible depuis:

Focus Pharmaceuticals Ltd

Code ATC:

C01EB; C01EB10

DCI (Dénomination commune internationale):

ADENOSINE

Dosage:

3 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

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

Domaine thérapeutique:

Other cardiac preparations; adenosine

Statut de autorisation:

Not marketed

Date de l'autorisation:

2013-01-11

Notice patient

12mm
158 mm
350 mm
12mm
FRONT
12mm
12mm
158 mm
350 mm
12mm
BACK
12mm
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE
GIVEN
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 side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Adcus is and what it is used for
2. What you need to know before you are given
Adcus
3. How you will be given Adcus
4. Possible side effects
5. How to store Adcus
6. Contents of the pack and other information
1.WHAT ADCUS IS AND WHAT IT IS USED FOR
Adcus
TM
3mg/ml
Solution
for
Infusion
(called
Adcus throughout the rest of this leaflet) belongs
to
a
group
of
medicines
called
coronary
vasodilators.
Adcus
is
given
with
other
medicines,
called
radionuclides, during a diagnostic test, called
myocardial perfusion imaging, to open up your
heart’s blood vessels to allow your blood to flow
more
freely.
Once
in
your
blood,
the
radionuclide allows the doctor or nurse to see
your heart and assess your heart condition.
This medicine is for diagnostic use only and is
used if you are incapable of exercise. You will
usually be in hospital when you receive this
medicine.
2.WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN ADCUS
DO NOT HAVE ADCUS
• if you are allergic to adenosine or any of the
other ingredients of this medicine (listed in
section 6);
• if you have an irregular heart rhythm and do
not currently have a pacemaker fitted;
• if you have a disorder that affects the heart’s
electrical activity (Long QT syndrome);
• if you have very low blood pressure (severe
hypotension);
• if you have unstable angina (severe chest
pain) that is not currently controlled by either
treatment or medication;
• if you have a type of heart failure where your
heart does not pump out enough blood;
• if
you
have
asthma
or
any
other
severe
breathing problems;
• if
you
are
taking

Résumé des caractéristiques du produit

Health Products Regulatory Authority
09 November 2018
CRN008HK6
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adenosine 3mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 3mg of adenosine.
Each vial contains 6mg of adenosine per 2ml of solution (3mg/ml).
It also contains 3.54mg (0.15mmol) of sodium per 1ml of solution.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adenosine 3mg/ml Solution for Injection is indicated in adults and
children aged 0 to
18 years.
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
Adenosine 3mg/ml Solution for 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.
Paediatric population
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular
tachycardia in children aged 0 to 18 years.
Health Products Regulatory Authority
09 November 2018
CRN008HK6
Page 2 of 12
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adenosine 3mg/ml Solution for Injection is intended for hospital use
only with
monitoring and cardiorespiratory resuscitation equipment available for
immediate
use, if necessary.
METHOD OF ADMINISTRATION
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 flus