CAVERJECT STERILE POWDER INJECTION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ALPROSTADIL (PROSTAGLANDIN E1)

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ALPROSTADIL (PROSTAGLANDIN E1)

Unit dalam pakej:

20 mcg/mL; 20 mcg/mL; 20 mcg/mL

Dikeluarkan oleh:

PFIZER MANUFACTURING BELGIUM NV,

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CAVERJECT
®
POWDER FOR SOLUTION FOR INJECTION
Alprostadil (20 μg)
WHAT IS IN THIS LEAFLET
1.
What Caverject is used for
2.
How Caverject works
3.
Before you use Caverject
4.
How to use Caverject
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Caverject
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CAVERJECT IS USED FOR
Caverject is used for erectile dysfunction
(inability to develop or maintain an
erection of the penis during sexual
activity) in adult males due to nerve
related, blood related, psychological
factors or other system disorders.
HOW CAVERJECT WORKS
After injection, the active ingredient of
Caverject is present in many mammalian
tissues and fluids. Caverject acts by
providing a relaxing effect on the smooth
muscle around blood vessels of the penis
so that blood can flow easily.
BEFORE YOU USE CAVERJECT
-
_When you must not use it_
Do not use Caverject if you
-
are allergic to Caverject or any of
the other ingredients present in this
medicine.
-
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.
-
have an implant in your penis.
-
have a condition in which sexual
activity should be avoided.
-
have a deformed penis (See section
“Before you start to use it”)
_Pregnancy and lactation_
Caverject is indicated only for use in
males.
-
_Before you start to use it_
Talk to your doctor before taking
Caverject if you
-
have anatomical deformations of the
penis, such as angulation (abnormal
bend or curve), phimosis (inability
to retract the penis foreskin),
cavernosal fibrosis (fibrous tissue
formation in penis), Peyronie's
disease or plaques.
-
have had a mini-stroke (transient
ischaemic attack)
-
have heart (cardiovascular) disorders
and brain (cerebrovascular)
disorders or are at risk of

Ciri produk

Pfizer Confidential
1
1. NAME OF THE MEDICINAL PRODUCT
CAVERJECT
®
(ALPROSTADIL)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Alprostadil 20 micrograms. When reconstituted, each 1 ml delivers a
dose of 20 micrograms
of alprostadil.
Excipient with known effect
Each 1 ml 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
Pharmaceutical form after reconstitution: injectable solution.
Way of administration: intracavernosal.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Alprostadil
is indicated for the treatment of erectile dysfunction in adult males
due to
neurogenic, vasculogenic, psychogenic or mixed aetiology.
Alprostadil may be a useful adjunct to other diagnostic tests in the
diagnosis of erectile
dysfunction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Alprostadil is administered by direct intracavernous injection. A half
inch, 27 to 30
gauge needle is generally recommended. The dose of alprostadil 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
must be alternated; prior to the injection, the injection site must be
cleansed with an
alcohol swab.
To reconstitute alprostadil using the pre-filled 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 alprostadil solution,
remove the 22
gauge needle, and fit the 30 gauge needle. Adjust volume to the
required dose for
Pfizer Confidential
2
injection. Following administration, any unused contents of the vial
or syringe shou