Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
ALPROSTADIL
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
G04BE01
POWDER FOR SOLUTION FOR INJECTION
ALPROSTADIL 20 MCG/VIAL
INTRACAVERNOSAL
Required
PFIZER MANUFACTURING BELGIUM NV/SA
ALPROSTADIL
ALPROSTADIL
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.
2020-06-30
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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument