CAVERJECT 5 Microgram Pdr+Solv for Soln for Inj

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

ALPROSTADIL

Διαθέσιμο από:

Pfizer Healthcare Ireland

Φαρμακολογική κατηγορία (ATC):

G04BE01

INN (Διεθνής Όνομα):

ALPROSTADIL

Δοσολογία:

5 Microgram

Φαρμακοτεχνική μορφή:

Pdr+Solv for Soln for Inj

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Drugs used in erectile dysfunction

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-02-14

Φύλλο οδηγιών χρήσης

 Package leaflet: Information for the user 

CAVERJECT
®
 5, 10 or 20 micrograms Powder and Solvent for Solution 
for Injection 

Alprostadil 
_PFIZER _

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 (liste

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Caverject 5 micrograms Powder and Solvent for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alprostadil 5 micrograms
When reconstituted, each 1ml delivers a dose of 5 micrograms of
alprostadil.
Excipients with known effect:
Each 1ml of reconstituted solution contains 7.96 mg of benzyl alcohol.
Sodium.
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).
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 of Caverject solution, remove the 22 gauge needle, and
fit the 30 gauge needle.
Adjust volume to the
required