البلد: هولندا
اللغة: الهولندية
المصدر: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ALPROSTADIL 3 mg/g
Recordati Ireland Ltd. (Co. Cork) Raheens East RINGASKIDDY (IERLAND)
G04BE01
ALPROSTADIL 3 mg/g
Crème
DODECYL-2-N,N-DIMETHYLAMINOPROPIONAATHYDROCHLORIDE ; ETHANOL ; ETHYLLAURAAT ; FOSFORZUUR (E 338) ; GUARAPROLOSE ; KALIUMDIWATERSTOFFOSFAAT 0-WATER (E 340) ; NATRIUMHYDROXIDE (E 524) ; WATER, GEZUIVERD,
Cutaan gebruik
Alprostadil
Hulpstoffen: DODECYL-2-N,N-DIMETHYLAMINOPROPIONAATHYDROCHLORIDE; ETHANOL; ETHYLLAURAAT; FOSFORZUUR (E 338); GUARAPROLOSE; KALIUMDIWATERSTOFFOSFAAT 0-WATER (E 340); NATRIUMHYDROXIDE (E 524); WATER, GEZUIVERD;
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ALPROSTADIL RECORDATI 3 MG/G CREAM Alprostadil 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 or pharmacist. - 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 ALPROSTADIL RECORDATI is and what it is used for 2. What you need to know before you use ALPROSTADIL RECORDATI 3. How to use ALPROSTADIL RECORDATI 4. Possible side effects 5. How to store ALPROSTADIL RECORDATI 6. Contents of the pack and other information 1. WHAT ALPROSTADIL RECORDATI IS AND WHAT IT IS USED FOR Alprostadil Recordati is used to treat erectile dysfunction (ED) in men 18 years of age or older. ED is the inability to attain or maintain an erection sufficient for sexual intercourse. There are several causes of ED including medications that you may be taking for other conditions, poor blood circulation in the penis, nerve damage, emotional problems, too much smoking or alcohol use, and hormonal problems. Often ED is due to more than one cause. Treatments for ED include switching medications, if you are taking a medication that causes ED, prescription medications, medical devices that produce an erection, surgical procedures to correct blood flow to the penis, penile implants and psychological counseling. After application of Alprostadil Recordati the onset of erection is within 5 to 30 minutes. You should not stop taking any prescription medications, unless told to do so by your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALPROSTADIL RECORDATI DO NOT USE ALPROSTADIL RECORDATI – if you have underlying disorders such as drop in blood pressure whe اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alprostadil Recordati 3 mg/g cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single use container contains 300 micrograms of alprostadil in 100 mg of cream (3 mg/g). For a full list of excipients see Section 6.1. 3 PHARMACEUTICAL FORM Cream Alprostadil Recordati is a white to off-white cream supplied in AccuDose, a single dose container. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of men ≥ 18 years of age with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Alprostadil Recordati is applied to the tip of the penis. Alprostadil Recordati should be used as needed to achieve an erection. Each Alprostadil Recordati AccuDose container is for single use only and should be properly discarded after use. The onset of effect is within 5 to 30 minutes after administration. The duration of effect is approximately 1 to 2 hours. However, the actual duration will vary from patient to patient. Each patient should be instructed by a medical professional on proper technique for administration of Alprostadil Recordati prior to self-administration. The maximum frequency of use is no more than 2-3 times per week and only once per 24-hour period. The initial dose should be recommended by a physician. A starting dose with the 300 mcg dose can be considered especially in patients with serious ED, co-morbidity or failure to PDE- 5 inhibitors. Those patients that do not tolerate the 300 mcg dose due to local side effects can be titrated to the lower 200 mcg dose. Patients should be given instruction on proper administration technique, information on possible side effects (e.g., dizziness, fainting) and the need to avoid operating machinery until one is aware of their tolerance to the drug. In the clinical trial there was a higher withdrawal rate in the 300 mcg treated group compared to the 200 mcg group, 30% compared to 2 اقرأ الوثيقة كاملة