CAVERJECT IMPULSE alprostadil 10microgram powder for injection with 0.5mL diluent dual chamber cartridge in single use syringe device

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alprostadil, Quantity: 20 microgram/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: benzyl alcohol; water for injections

Administration route:

Intracavernosal

Units in package:

2 x dual chamber cartridge in single use syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Intracavernosal alprostadil (PGE1) is indicated for the treatment of erectile dysfunction in adult males. Intracavernosal alprostadil may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Product summary:

Visual Identification: ; Container Type: Cartridge; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2002-07-29

Patient Information leaflet

CAVERJECT
® IMPULSE
_alprostadil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Caverject Impulse. 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 using Caverject
Impulse against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CAVERJECT
IMPULSE IS USED FOR
Caverject Impulse may be prescribed
by your doctor for the treatment of
erectile dysfunction (inability to
maintain an erection to have sexual
intercourse).
Caverject Impulse may also be used
to help in the diagnosis of erectile
dysfunction.
Caverject Impulse contains
alprostadil as the active ingredient.
Alprostadil is also known as
prostaglandin E1 (PGE1) and is
found naturally in many parts of your
body.
Caverject Impulse works by
increasing the blood flow to your
penis. The increased blood flowing
into the penis is trapped in the
spongy erectile tissue of the penis
called the corpora cavernosa. When
these chambers fill with blood they
swell and your penis becomes erect.
Caverject Impulse is injected into the
side of the penis and should produce
an erection in 5 to 20 minutes. The
erection should last for about 30 to
60 minutes.
Caverject Impulse is available only
with a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CAVERJECT
IMPULSE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE
CAVERJECT IMPULSE
_WHEN YOU MUST NOT USE IT_
DO NOT USE CAVERJECT IMPULSE IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
alprostadil, the active ingredient
in Caverject Impulse
•
any of the ingredients listed at the
end of this leaflet.
•
have a penis which is scarred, not
straight or if you experience
painful erections (Peyronie's
d

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
CAVERJECT
® IMPULSE (ALPROSTADIL)
1.
NAME OF THE MEDICINE
Alprostadil.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Caverject Impulse dual chamber syringe is available in two strengths,
10 and 20 micrograms.
Each 0.5 mL cartridge delivers a maximum dose of 10 micrograms or 20
micrograms of
alprostadil.
EXCIPIENT(S) WITH KNOWN EFFECT
Each mL of reconstituted solution contains 8.9 mg/mL of benzyl
alcohol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for intracavernosal injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Intracavernosal alprostadil (PGE
1
) is indicated for the treatment of erectile dysfunction in
adult males. Intracavernosal alprostadil may be a useful adjunct to
other diagnostic tests in
the diagnosis of erectile dysfunction.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Before initiation of treatment with Caverject Impulse, patients should
be carefully assessed
by a specialist practitioner in erectile dysfunction with appropriate
training in the use of this
drug. The dose should be titrated carefully according to individual
need.
ERECTILE DYSFUNCTION OF NEUROGENIC OR PSYCHOGENIC ETIOLOGY
If the erectile dysfunction is known to be of neurogenic or
psychogenic aetiology, the
generally recommended initial dose of Caverject Impulse is 2.5
micrograms with subsequent
upward titration of the dose in increments of 2.5 micrograms.
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Page 2 of 12
ERECTILE DYSFUNCTION OF ARTERIOGENIC ORIGIN OR DUE TO OTHER ORGANIC
CAUSES
If the erectile dysfunction is known to be of arteriogenic origin or
due to other organic
causes, the generally recommended initial dose of Caverject Impulse is
5 micrograms with
subsequent upward titration of the dose in increments of 5 micrograms.
CAVERJECT IMPULSE AS AN ADJUNCT TO THE DIAGNOSIS OF ERECTILE
DYSFUNCTION
If the aetiology of the erectile dysfunction is unknown or the
Cave