CAVERJECT 20 MCG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

ALPROSTADIL

Disponível em:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Código ATC:

G04BE01

Forma farmacêutica:

POWDER FOR SOLUTION FOR INJECTION

Composição:

ALPROSTADIL 20 MCG/VIAL

Via de administração:

INTRACAVERNOSAL

Tipo de prescrição:

Required

Fabricado por:

PFIZER MANUFACTURING BELGIUM NV/SA

Grupo terapêutico:

ALPROSTADIL

Área terapêutica:

ALPROSTADIL

Indicações terapêuticas:

Treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic or mixed etiology. Useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Data de autorização:

2020-06-30

Folheto informativo - Bula

ةعرجلا صحف
.امامت كتعرجل ةمئلاملا ةملاعلا لباقم
سبكملا نوكي ىتح طغضلا لصاو
.ةملاعلا رهظت نيأ بيبطلا كل حضوأ دقل
لولحملا نقح II مسقلا
.هاندأ امهفصو دراولا ( corpora cavernosa)
نيتقطنملا ىدحإ يف زهاجلا لولحملا نقح
ُ
ي
•
.نلآا اهحتفا ،ةيناثلا ميقعتلا ةشاش
لامعتساب بيبطلا كل ىصوأ اذإ .احاترم
نوكت يكل دعتساو كسبلام عزنا
•
وضعلا يف اهنم ءزج ءاقبو ةربإ رسك نع
تاغيلبت كانه .رسكلل ادج ةضرعم ةيوتلملا
ةربلإا .ةيوتلم تسيل ةربلإا نأ نم دكأت
تضرعت اذإ .ةيحارج ةيلمعب مسجلا نم
ةربلإا ةلازإو ىفشتسملا يف ثوكملا ىلإ
ةجاح كانه تناك ةنيعم تلااح يفو ،يركذلا
ةربلإا لعج ةلواحم زوجي لا .ربلإا ربع
بقثلل ةمواقم ةقلغم ةيواح يف اهنم
صلختلا بجيو اهلامعتسا زوجي لا
،ءاوتللال ةربلإا
يف رهظي امك فطلب طغضاو ةبابسلاو
ماهبلإاب ةفلقلا كسمأ .ةنقحملا ىلع
،ةلمعتسم ريغ ،ةديدج ةمقعم ةربإ تبث
.ةميقتسم
.جراخلا وحن نقحلا ةقطنم زربت .C مسرلا
•
ىلع فطلب طغضا .هقوف ماهبلإاو ،نيتيصخلا
نم برقلاب هتحت نيعبصإ نوكي امنيب
،ةيماملأا ةهجلا نم يركذلا وضعلا كسمأ
.فلخلا وحن ةفلقلا بحسا ،ناتخلا ةيلمع
زتجت مل اذإ .نقحلا ةقطنم زاربلإ
ةبابسلاو ماهبلإا نيب يركذلا وضعلا
•
. A مسرلا رظنا ،ةنكادلا ةقطنملا يف
نقحلا ةيلمع متت
•
.فجت ةقطنملا عدو ةيناثلا ميقعتلا ةشاشب
نقحلا ةقطنم ر
ّ
هط ،بيبطلا

Características técnicas

Caverject LPD CC 150623
Page 1 of ; 2023-0086474
_ _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Caverject 10 micrograms
Caverject 20 micrograms
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alprostadil 10 micrograms.
When reconstituted, each 1ml delivers a dose of 10 micrograms of
alprostadil.
Alprostadil 20 micrograms.
When reconstituted, each 1ml delivers a dose of 20 micrograms of
alprostadil.
Alprostadil 10 micrograms & 20 micrograms:
Excipient 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 for Solution for Injection
A white to off-white powder.
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Caverject is administered by direct intracavernous injection. A half
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 must
Caverject LPD CC 150623
Page 2 of ; 2023-0086474
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 req