ADENOSINE JUNO adenosine 30 mg/10 mL solution for injection vial

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

adenosine, Quantity: 10 mg

Dostupné s:

Juno Pharmaceuticals Pty Ltd

Léková forma:

Injection, solution

Složení:

Excipient Ingredients: sodium chloride; water for injections

Podání:

Intravenous

Jednotky v balení:

6, 10, 5

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Intravenous ADENOSINE JUNO is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging, in patients unable to exercise adequately.

Přehled produktů:

Visual Identification: A clear colourless solution free from visible particles filled in 10mL, clear glass vial, stoppered with 13mm red or grey colour serum chloro butyl stopper and sealed with flip off aluminium seals; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Registered

Datum autorizace:

2018-07-31

Informace pro uživatele

Adenosine Juno Consumer Medicine Information
Juno Pharmaceuticals Pty Ltd
1 ADENOSINE JUNO
_Adenosine _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Adenosine Juno.
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 ADENOSINE JUNO
IS USED FOR
Adenosine Juno is used as an aid
to
doctors,
to
understand
how
your
heart
is
working.
Adenosine Juno is used during
radionuclide
imaging
of
your
heart.
Adenosine Juno is given to you
before
the
radionuclide
(the
agent which allows them to see
your heart).
Adenosine
Juno
works
by
opening up your heart's blood
vessels to allow blood to flow
more freely and can then be seen
more clearly by doctors.
Adenosine Juno is only given in
hospitals. It is given to you as an
injection.
Your
doctor,
however,
may
prescribe
Adenosine
Juno
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 ADENOSINE JUNO
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 ADENOSINE JUNO
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
INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET
-
ANY
OTH

Charakteristika produktu

Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
ADENOSINE JUNO (ADENOSINE)_ _
_ _
1 NAME OF THE MEDICINE
Adenosine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Adenosine Juno is a sterile solution for intravenous infusion,
provided in clear glass vials.
Each vial contains 30 mg of adenosine in 10 mL of a 0.9% w/v solution
of sodium chloride in
sterile water for injections. The pH is between 4.5 and 7.5.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS
3. PHARMACEUTICAL FORM
Adenosine is a white crystalline powder slightly soluble in water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intravenous Adenosine Juno is a coronary vasodilator for use in
conjunction with radionuclide
myocardial perfusion imaging, in patients unable to exercise
adequately.
4.2 DOSE AND METHOD OF ADMINISTRATION
Adenosine Juno is intended for use in hospitals, where facilities for
cardiac monitoring and
resuscitation are available. Product is for single use in one patient
only. Discard any residue.
DIAGNOSTIC DOSE
ADULTS
1.
Adenosine Juno should be administered undiluted as a continuous
peripheral
intravenous infusion at a dose of 140 µg/kg/min over fixed time
interval of six minutes
(total dose 0.84 mg/kg) using an infusion pump. Separate venous sites
for Adenosine
Juno and radionuclide administration are recommended to avoid an
adenosine bolus
effect.
2.
After three minutes of Adenosine Juno infusion, the radionuclide is
injected.
3.
Heart rate and blood pressure should be recorded at 1 minute
intervals, and ECG should
be monitored continuously during Adenosine Juno infusion. To avoid an
adenosine bolus
effect, blood pressure should be measured in the arm opposite to the
Adenosine Juno
infusion.
The table below is given as a guide for adjustment of the infusion
rate of undiluted Adenosine
Juno, in line with body weight (total dose 0.84 mg/kg).
Australian Product Information
Page | 2
Patient Weight
Infusion Rate
_(kg) _
_(mL/min) _
45-49
2.1
50-54
2.3
55-59
2.6
60-64
2.8
65-69
3.0
70-74
3.3
75