Adenosine 30mg/10ml solution for infusion

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

ADENOSINE

Dostępny od:

Wockhardt UK Limited

Kod ATC:

C01EB; C01EB10

INN (International Nazwa):

ADENOSINE

Dawkowanie:

30 milligram/ 10 millilitre

Forma farmaceutyczna:

Solution for infusion

Typ recepty:

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

Dziedzina terapeutyczna:

Other cardiac preparations; adenosine

Status autoryzacji:

Marketed

Data autoryzacji:

2013-10-04

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
ADENOSINE 30MG/10ML SOLUTION FOR INFUSION
(Referred to as Adenosine Infusion 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 nurse
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 nurse.
IN THIS LEAFLET:
1. What Adenosine Infusion and what it is used for
2. Before you are given Adenosine Infusion
3. How you will be given Adenosine Infusion
4. Possible side effects
5. How to store Adenosine Infusion
6. Further information
1. WHAT ADENOSINE INFUSION IS AND WHAADENOSINE INFUSION IS AND WHAT
IT ISUSED FOR
1. WHAT ADENOSINE INFUSION IS AND WHAT IT IS USED FOR
The name of your medicine is Adenosine Infusion. The active ingredient
in your medicine is
adenosine. Adenosine belongs to a group of medicines called coronary
vasodilators.
This medicine is for diagnostic use only.
Adenosine Infusion is given before a test called “myocardial
perfusion imaging” to look at your
heart. During this test you are given a medicine called a
“radiopharmaceutical”.
Adenosine Infusion works by opening up your heart’s blood vessels
and allowing blood to flow more
freely. This allows the radiopharmaceutical medicine to get into your
heart. The doctor can see your
heart and assess your heart condition. This is used if you are not
capable of exercise or if an exercise
stress test is not possible.
2. BEFORE YOU ARE GIVEN ADENOSINE INFUSION
YOU SHOULD NOT BE GIVEN ADENOSINE INFUSION IF YOU

are allergic (hypersensitive) to adenosine or to any of the other
ingredients in this medicine
(see section 6. Further information)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling

Charakterystyka produktu

Health Products Regulatory Authority
05 March 2019
CRN008T5V
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adenosine 30mg/10ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 30mg of adenosine per 10ml (3mg/ml).
Excipient: each vial contains approximately 36 mg of sodium per vial
(10ml).
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless solution free from visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intravenous (IV) adenosine infusion is a coronary vasodilator for use
in conjunction with radionuclide myocardial perfusion
imaging in patients who cannot exercise adequately or for whom
exercise is inappropriate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adenosine infusion is intended for use in hospitals with monitoring
and cardio-respiratory resuscitation equipment available
for immediate use if necessary.
It should be administered following the same procedure as for exercise
testing where facilities for cardiac monitoring and
cardio-respiratory resuscitation are available. During administration
of adenosine infusion continuous ECG control is necessary
as life-threatening arrhythmia might occur. Heart rate and blood
pressure should be monitored every minute.
Posology:
Adults:
1. Adenosine infusion should be administered undiluted as a continuous
peripheral intravenous infusion at a dose of 140
µg/kg/min for six minutes using an infusion pump. Separate venous
sites for adenosine infusion and radionuclide
administration are recommended to avoid an adenosine bolus effect.
2. After three minutes of adenosine infusion, the radionuclide is
injected to ensure sufficient time for peak coronary blood flow
to occur. The optimal vasodilator protocol is achieved with six
minutes of adenosine infusion.
3. To avoid an adenosine bolus effect, blood pressure should be
measured in the arm opposite to the adenosine infusion.
The table below is given as a guide for adjustment of