ADENOCOR Adenosine 6mg/2mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

adenosine, Quantity: 3 mg/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous Infusion

Units in package:

6 x 2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

THERAPEUTIC INDICATIONS: 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 is not effective in converting atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. In this respect adenosine should be used as an adjunct to, but not a replacement for, clinical and ECG observations. It should be only used when, despite all diagnostic attempts, doubt still persists. Improved diagnostic sensitivity of intracavity electrophysiological investigations

Product summary:

Visual Identification: A clear, colourless solution.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-12-19

Patient Information leaflet

ADENOCOR
®
_Adenosine_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Adenocor.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT ADENOCOR IS
USED FOR
Adenocor is a type of medicine used
to treat a condition called
paroxysmal supraventricular
tachycardia (including a condition
called Wolff-Parkinson-White
syndrome). This is when the heart
beats too rapidly. If left untreated this
condition can be life threatening.
Adenocor can also be used as an aid
to doctors, to understand how your
heart is working.
Adenocor works by slowing down
the electrical impulses which control
the heart rhythm. This allows the
heart rhythm to return to normal.
Adenocor is only given in hospitals.
It is given to you as an injection. The
effect of Adenocor only lasts for a
couple of minutes.
Your doctor, however, may prescribe
Adenocor for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT RECEIVE ADENOCOR IF YOU
HAVE:
•
asthma or any other lung disease
•
recently had a heart transplant
•
some other problems with your
heart or heart rhythm
•
severe low blood pressure
DO NOT RECEIVE ADENOCOR IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO:
•
ANY OF THE INGREDIENT

Summary of Product characteristics

adenocor-ccdsv8-piv5-16jul20
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION – ADENOCOR
®
(ADENOSINE)
1
NAME OF THE MEDICINE
Adenosine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 6 mg of adenosine in 2 mL of a 0.9% w/v solution of
sodium chloride in
sterile water for injections.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Adenocor is a clear colourless sterile solution for intravenous
injection (rapid bolus).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rapid conversion to a normal sinus rhythm of paroxysmal
supraventricular tachycardias,
including those associated with accessory bypass tracts
_ _
(Wolff-Parkinson-White syndrome).
DIAGNOSTIC INDICATIONS
Aid to diagnosis of broad or narrow QRS complex supraventricular
tachycardias. Although
Adenocor is not effective in converting atrial flutter, atrial
fibrillation or ventricular tachycardia
to sinus rhythm, the slowing of AV conduction helps diagnosis of
atrial activity.
In this respect adenosine should be used as an adjunct to, but not a
replacement for, clinical
and ECG observations. It should be used only when, despite all
diagnostic attempts, doubt still
persists.
Improved diagnostic sensitivity of intracavity electrophysiological
investigations.
4.2
DOSE AND METHOD ADMINISTRATION
Adenocor should be used only in hospitals, with monitoring and
cardiorespiratory resuscitation
equipment available for immediate use if necessary. 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, it should be administered either
directly into a vein or into an
adenocor-ccdsv8-piv5-16jul20
Page 2 of 11
IV line. If administered via 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 incre