Caverject 10 micrograms Powder and Solvent for Solution for Injection

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Alprostadil

थमां उपलब्ध:

Pfizer Healthcare Ireland

ए.टी.सी कोड:

G04BE; G04BE01

INN (इंटरनेशनल नाम):

Alprostadil

डोज़:

10 microgram(s)

फार्मास्यूटिकल फॉर्म:

Powder and solvent for solution for injection

प्रिस्क्रिप्शन प्रकार:

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

चिकित्सीय क्षेत्र:

Drugs used in erectile dysfunction; alprostadil

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

1997-04-04

सूचना पत्रक

Package leaflet: Information for the user
Caverject
®
10 OR 20 MICROGRAMS
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Alprostadil
Read all of this leaflet carefully before you start using this
medicine because
it contains important information for you
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others.
It may harm them, even if their signs of illness are the same as
yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Caverject is and what it is used for
2. What you need to know before you use Caverject
3. How to use Caverject
4. Possible side effects
5. How to store Caverject
6. Contents of the pack and other information
1.
What Caverject is and what it is used for
Caverject contains alprostadil which is similar to the natural
substance in your body called prostaglandin E1. It widens
blood vessels so that blood can flow in your penis more easily. This
makes it easier for you to have an erection.
Caverject is used for “erectile dysfunction” including weak
erections or impotence. Your doctor may also use it to help find
the exact cause of your erectile dysfunction along with other tests.
Caverject is not suitable for children under 18 years of age.
2.
What you need to know before you use Caverject
Do not use Caverject:
•
if you are allergic (hypersensitive) to Caverject or any other
medicines containing alprostadil or any of the other
ingredients of Caverject (listed in section 6).
•
if you have sickle cell anaemia (a blood disease), leukaemia (cancer
of the blood), multiple myeloma (bone cancer)
or any other problem which increases the risk of getting
“priapism”. This is a painful condition when your penis
continues to remain erect.
•
if you have a penis which is scarred or not straight which may
sometim

उत्पाद विशेषताएं

Health Products Regulatory Authority
08 January 2021
CRN009ZCR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caverject 10 micrograms Powder and Solvent for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alprostadil 10 micrograms
When reconstituted, each 1ml delivers a dose of 10 micrograms of
alprostadil.
Excipients with known effect:
Each 1ml of reconstituted solution contains 8.4 mg of benzyl alcohol,
equivalent to 8.4 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: A white to off-white lyophilized powder.
Solvent: A clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Caverject is indicated for the treatment of erectile dysfunction in
adult males due to neurogenic, vasculogenic, psychogenic or
mixed aetiology.
Caverject may be a useful adjunct to other diagnostic tests in the
diagnosis of erectile dysfunction.
Caverject is not indicated for paediatric use (see section 4.4 Benzyl
alcohol).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Caverject is administered by direct intracavernous injection. A
1/2-inch, 27 to 30 gauge needle is generally recommended. The
dose of Caverject should be individualised for each patient by careful
titration under supervision by a physician.
The intracavernosal injection must be done under sterile conditions.
The site of injection is usually along the dorsolateral
aspect of the proximal third of the penis. Visible veins should be
avoided. Both the side of the penis that is injected and the site
of injection should be alternated; prior to the injection, the
injection site must be cleansed with an alcohol swab.
To reconstitute Caverject using the prefilled diluent syringe: flip
off the plastic cap from the vial, and use one of the swabs to
wipe the rubber cap. Fit the 22 gauge needle to the syringe.
Inject the 1 ml of diluent into the vial, and shake to dissolve the
powder entirely. Withdraw slightly more than the required
dose