CAVERJECT 20 MCG

国家: 以色列

语言: 英文

来源: Ministry of Health

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下载 资料单张 (PIL)
17-08-2016
下载 产品特点 (SPC)
22-08-2023
下载 公众评估报告 (PAR)
11-04-2021

有效成分:

ALPROSTADIL

可用日期:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC代码:

G04BE01

药物剂型:

POWDER FOR SOLUTION FOR INJECTION

组成:

ALPROSTADIL 20 MCG/VIAL

给药途径:

INTRACAVERNOSAL

处方类型:

Required

厂商:

PFIZER MANUFACTURING BELGIUM NV/SA

治疗组:

ALPROSTADIL

治疗领域:

ALPROSTADIL

疗效迹象:

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.

授权日期:

2020-06-30

资料单张

                                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
                                
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产品特点

                                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
                                
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其他语言的文件

资料单张 资料单张 阿拉伯文 20-12-2021
资料单张 资料单张 希伯来文 17-08-2016

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