국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
ALPROSTADIL
Clinical Technology Centre (International) Limited (PPD)
ALPROSTADIL
2 mg/g
Cream
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ VITAROS 2MG/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 phamacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Vitaros is and what it is used for 2. What you need to know before you use Vitaros 3. How to use Vitaros 4. Possible side effects 5. How to store Vitaros 6. Contents of the pack and other information 1. WHAT VITAROS IS AND WHAT IT IS USED FOR Vitaros is available in two dosage strengths of 200 and 300 micrograms alprostadil in 100 mg of cream.Vitaros 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 Vitaros the onset of erection is within 5 to 30 minutes. Y 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vitaros 2mg/g Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single use container contains 200 micrograms of alprostadil in 100 mg of cream (2 mg/g). For a full list of excipients see Section 6.1. 3 PHARMACEUTICAL FORM Cream Vitaros is a white to off-white cream supplied in AccuDose, a single dose container. AccuDose is a container consisting of a plunger, barrel, and protective cap provided in a protective sachet. 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 Vitaros is applied to the tip of the penis. Vitaros is available in two dosage strengths of 200 and 300 mcg alprostadil in 100 mg of cream. Vitaros should be used as needed to achieve an erection. Each Vitaros 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 Vitaros 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 전체 문서 읽기