PERSANTIN dipyridamole 10mg/2mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dipyridamole, Quantity: 5 mg/mL

Available from:

Clinect Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: macrogol 600; tartaric acid; water for injections; hydrochloric acid

Administration route:

Intravenous

Units in package:

5x2mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 29 AUGUST 2000: Persantin Ampoules are indicated as an alternative to exercise in myocardial imaging.

Product summary:

Visual Identification: A clear, yellow solution practically free from suspended particles; Container Type: Ampoule; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1991-09-26

Patient Information leaflet

PERSANTIN
® AMPOULES
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PERSANTIN AMPOULES?
Persantin Ampoules contain the active ingredient dipyridamole.
Persantin Ampoules are used as a tool in detecting potential
problems on how the heart functions in times of stress.
For more information, see Section 1. Why am I using Persantin
Ampoules? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PERSANTIN AMPOULES?
Do not use if you have ever had an allergic reaction to dipyridamole
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Persantin Ampoules? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Persantin Ampoules and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PERSANTIN AMPOULES?
•
Your doctor will decide what dose you will receive, based on your body
weight.
•
Persantin Ampoules are given as an infusion (drip) into your veins,
over several minutes.
More instructions can be found in Section 4. How do I use Persantin
Ampoules? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PERSANTIN AMPOULES?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Persantin.
•
Tell your doctor if you are pregnant or if you think you may be
pregnant or are breast-feeding.
•
Tell your doctor if you have or have had any of the following medical
conditions:
•
any heart condition or heart disease
•
asthma, high or low blood pressure
•
unexplained fainting or mini-stroke
•
severe muscle disease (myasthenia gravis).
THINGS YOU
SHOULD NOT DO
•
You

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
PERSANTIN® (DIPYRIDAMOLE) INJECTION
AMPOULE
1.
NAME OF THE MEDICINE
Dipyridamole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PERSANTIN Ampoules contain dipyridamole 10 mg in 2 mL and are intended
for intravenous administration.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
PERSANTIN 10 mg/2 mL solution for injection is a clear, yellow
solution practically free from suspended
particles.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PERSANTIN Ampoules are indicated as an alternative to exercise in
myocardial imaging.
4.2 DOSE AND METHOD OF ADMINISTRATION
Perfusion imaging: The dose of intravenous PERSANTIN as an adjunct to
myocardial perfusion imaging should
be adjusted according to the weight of the patient. The recommended
dose is 0.14 mg/kg/min (0.56 mg/kg
total) infused over 4 minutes. Although the maximum tolerated dose has
not been determined, clinical
experience suggests that a total dose beyond 60 mg is not needed for
any patient.
Stress echo: The recommended protocol for intravenous dosing is 0.56
mg/kg over a 4 minute period, followed
by 4 minutes of no dose, and if echo monitoring performed and analysed
in real time shows no changes, by
an additional 0.28 mg/kg over 2 minutes, yielding a cumulative dosage
of 0.84 mg/kg over 10 minutes. This
“high dose” protocol may also be given in 6 minutes. Most
experience has been gained using a total dose of
0.84 mg/kg over 10 minutes or 6 minutes, therefore it is not
recommended to exceed this dose for diagnostic
testing.
Prior to intravenous administration, PERSANTIN should be diluted in at
least a 1:2 ratio with sodium chloride
0.45% or 0.9% or glucose 5% to a total volume of approximately 20 to
50 mL. Infusion of undiluted
PERSANTIN may cause local irritation. The imaging agent should be
injected within 5 minutes following
administration of intravenous PERSANTIN.
PERSANTIN for intravenous administration should not be mixed with
other drugs in the same syringe or
infusion