਍䘀漀爀 椀渀琀爀愀瘀攀渀漀甀猀 甀猀攀 漀渀氀礀⸀ 倀愀爀攀渀琀攀爀愀氀 搀爀甀最 瀀爀漀搀甀挀琀猀 猀栀漀甀氀搀 戀攀 椀渀猀瀀攀挀琀攀搀 瘀椀猀甀愀氀氀礀 昀漀爀 瀀愀爀琀椀挀甀氀愀琀攀 洀愀琀琀攀爀 愀渀搀 搀椀猀挀漀氀漀爀愀琀椀漀渀 瀀爀椀漀爀 琀漀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀Ⰰ 眀栀攀渀攀瘀攀爀 猀漀氀甀琀椀漀渀 愀渀搀 挀漀渀琀愀椀渀攀爀 瀀攀爀洀椀琀⸀ 䐀漀 渀漀琀 甀猀攀 椀昀 瀀愀爀琀椀挀甀氀愀琀攀 洀愀琀琀攀爀 椀猀 猀攀攀渀 漀爀 椀昀 琀栀攀 挀漀渀琀攀渀琀猀 漀昀 琀栀攀 瘀椀愀氀 愀爀攀 搀椀猀挀漀氀漀爀攀搀 漀爀 椀昀 琀栀攀 瘀椀愀氀 椀猀 搀愀洀愀最攀搀 椀渀 愀渀礀 眀愀礀⸀ഀഀ
਍㰀戀爀㸀ഀഀ For spider veins (varicose veins ≤1 mm in diameter), use Asclera 0.5%. For reticular veins (varicose veins 1 to 3 mm in diameter), use Asclera 1%. Use 0.1 to 0.3 mL per injection and no more than 10 mL per session.਍㰀戀爀㸀ഀഀ
਍唀猀攀 愀 猀礀爀椀渀最攀 ⠀最氀愀猀猀 漀爀 瀀氀愀猀琀椀挀⤀ 眀椀琀栀 愀 昀椀渀攀 渀攀攀搀氀攀 ⠀琀礀瀀椀挀愀氀氀礀Ⰰ ㈀㘀ⴀ 漀爀 ㌀　ⴀ最愀甀最攀⤀⸀ 䤀渀猀攀爀琀 琀栀攀 渀攀攀搀氀攀 琀愀渀最攀渀琀椀愀氀氀礀 椀渀琀漀 琀栀攀 瘀攀椀渀 愀渀搀 椀渀樀攀挀琀 琀栀攀 猀漀氀甀琀椀漀渀 猀氀漀眀氀礀 眀栀椀氀攀 琀栀攀 渀攀攀搀氀攀 椀猀 猀琀椀氀氀 椀渀 琀栀攀 瘀攀椀渀⸀ 䄀瀀瀀氀礀 漀渀氀礀 最攀渀琀氀攀 瀀爀攀猀猀甀爀攀 搀甀爀椀渀最 椀渀樀攀挀琀椀漀渀 琀漀 瀀爀攀瘀攀渀琀 瘀攀椀渀 爀甀瀀琀甀爀攀⸀ 䄀昀琀攀爀 琀栀攀 渀攀攀搀氀攀 栀愀猀 戀攀攀渀 爀攀洀漀瘀攀搀 愀渀搀 琀栀攀 椀渀樀攀挀琀椀漀渀 猀椀琀攀 栀愀猀 戀攀攀渀 挀漀瘀攀爀攀搀Ⰰ 愀瀀瀀氀礀 挀漀洀瀀爀攀猀猀椀漀渀 椀渀 琀栀攀 昀漀爀洀 漀昀 愀 猀琀漀挀欀椀渀最 漀爀 戀愀渀搀愀最攀⸀ 䄀昀琀攀爀 琀栀攀 琀爀攀愀琀洀攀渀琀 猀攀猀猀椀漀渀Ⰰ 攀渀挀漀甀爀愀最攀 琀栀攀 瀀愀琀椀攀渀琀 琀漀 眀愀氀欀 昀漀爀 ㄀㔀 琀漀 ㈀　 洀椀渀甀琀攀猀⸀ 䬀攀攀瀀 琀栀攀 瀀愀琀椀攀渀琀 甀渀搀攀爀 漀戀猀攀爀瘀愀琀椀漀渀 琀漀 搀攀琀攀挀琀 愀渀礀 愀渀愀瀀栀礀氀愀挀琀椀挀 漀爀 愀氀氀攀爀最椀挀 爀攀愀挀琀椀漀渀 ⠀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀⤀⸀ഀഀ
਍㰀戀爀㸀ഀഀ Maintain compression for 2 to 3 days after treatment of spider veins and for 5 to 7 days for reticular veins. For extensive varicosities, longer compression treatment with compression bandages or a gradient compression stocking of a higher compression class is recommended. Post-treatment compression is necessary to reduce the risk of deep vein thrombosis.਍㰀戀爀㸀ഀഀ
਍刀攀瀀攀愀琀 琀爀攀愀琀洀攀渀琀猀 洀愀礀 戀攀 渀攀挀攀猀猀愀爀礀 椀昀 琀栀攀 攀砀琀攀渀琀 漀昀 琀栀攀 瘀愀爀椀挀漀猀攀 瘀攀椀渀猀 爀攀焀甀椀爀攀猀 洀漀爀攀 琀栀愀渀 ㄀　 洀氀⸀ 吀栀攀猀攀 琀爀攀愀琀洀攀渀琀猀 猀栀漀甀氀搀 戀攀 猀攀瀀愀爀愀琀攀搀 戀礀 ㄀ 琀漀 ㈀ 眀攀攀欀猀⸀ഀഀ
਍㰀戀爀㸀ഀഀ Small intravaricose blood clots (thrombi) that develop may be removed by stab incision and thrombus expression (microthrombectomy).਍㰀戀爀㸀ഀഀ
਍ഀഀ ਍㰀愀 渀愀洀攀㴀∀䘀伀刀䴀匀∀㸀㰀⼀愀㸀ഀഀ ਍㰀倀㸀ഀഀ

਍䄀猀挀氀攀爀愀 椀猀 愀瘀愀椀氀愀戀氀攀 愀猀 愀 　⸀㔀─ 愀渀搀 ㄀─ 猀漀氀甀琀椀漀渀 椀渀 ㈀ 洀䰀 最氀愀猀猀 愀洀瀀甀氀攀猀⸀ഀഀ

਍㰀⼀愀㸀ഀഀ

਍㰀⼀倀㸀ഀഀ

਍䄀䐀嘀䔀刀匀䔀 刀䔀䄀䌀吀䤀伀一匀ഀഀ

਍㰀倀㸀ഀഀ Clinical Studies Experience਍㰀戀爀㸀ഀഀ
਍䈀攀挀愀甀猀攀 挀氀椀渀椀挀愀氀 琀爀椀愀氀猀 愀爀攀 挀漀渀搀甀挀琀攀搀 甀渀搀攀爀 眀椀搀攀氀礀 瘀愀爀礀椀渀最 挀漀渀搀椀琀椀漀渀猀Ⰰ 愀搀瘀攀爀猀攀 爀攀愀挀琀椀漀渀 爀愀琀攀猀 漀戀猀攀爀瘀攀搀 椀渀 琀栀攀 挀氀椀渀椀挀愀氀 琀爀椀愀氀猀 漀昀 愀 搀爀甀最 挀愀渀渀漀琀 戀攀 搀椀爀攀挀琀氀礀 挀漀洀瀀愀爀攀搀 琀漀 爀愀琀攀猀 椀渀 琀栀攀 挀氀椀渀椀挀愀氀 琀爀椀愀氀猀 漀昀 愀渀漀琀栀攀爀 搀爀甀最 愀渀搀 洀愀礀 渀漀琀 爀攀昀氀攀挀琀 琀栀攀 爀愀琀攀猀 漀戀猀攀爀瘀攀搀 椀渀 瀀爀愀挀琀椀挀攀⸀ഀഀ
਍㰀戀爀㸀ഀഀ In 5 controlled randomized clinical trials, Asclera has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo. Patients were 18 to 70 years old. The patient population was predominately female and consisted of Caucasian and Asian patients.਍㰀戀爀㸀ഀഀ
਍吀愀戀氀攀 ㄀ 猀栀漀眀猀 愀搀瘀攀爀猀攀 攀瘀攀渀琀猀 洀漀爀攀 挀漀洀洀漀渀 眀椀琀栀 䄀猀挀氀攀爀愀 漀爀 猀漀搀椀甀洀 琀攀琀爀愀搀攀挀礀氀 猀甀氀昀愀琀攀 ⠀匀吀匀⤀ ㄀─ 琀栀愀渀 眀椀琀栀 瀀氀愀挀攀戀漀 戀礀 愀琀 氀攀愀猀琀 ㌀─ 椀渀 琀栀攀 瀀氀愀挀攀戀漀ⴀ 挀漀渀琀爀漀氀氀攀搀 䔀䄀匀䤀 猀琀甀搀礀 ⠀猀攀攀 䌀氀椀渀椀挀愀氀 匀琀甀搀椀攀猀 嬀㄀㐀崀⤀⸀ 䄀氀氀 漀昀 琀栀攀猀攀 眀攀爀攀 椀渀樀攀挀琀椀漀渀 猀椀琀攀 爀攀愀挀琀椀漀渀猀 愀渀搀 洀漀猀琀 眀攀爀攀 洀椀氀搀⸀ഀഀ
਍㰀⼀甀氀㸀ഀഀ ਍㰀甀氀㸀ഀഀ
਍唀氀琀爀愀猀漀甀渀搀 攀砀愀洀椀渀愀琀椀漀渀猀 愀琀 漀渀攀 眀攀攀欀 ⠀넀㌀ 搀愀礀猀⤀ 愀渀搀 ㄀㈀ 眀攀攀欀猀 ⠀넀㈀ 眀攀攀欀猀⤀ 愀昀琀攀爀 琀爀攀愀琀洀攀渀琀 搀椀搀 渀漀琀 爀攀瘀攀愀氀 搀攀攀瀀 瘀攀椀渀 琀栀爀漀洀戀漀猀椀猀 椀渀 愀渀礀 琀爀攀愀琀洀攀渀琀 最爀漀甀瀀⸀ഀഀ
਍㰀戀爀㸀ഀഀ Post-marketing Safety Experience਍㰀戀爀㸀ഀഀ
਍吀栀攀 昀漀氀氀漀眀椀渀最 愀搀瘀攀爀猀攀 爀攀愀挀琀椀漀渀猀 栀愀瘀攀 戀攀攀渀 爀攀瀀漀爀琀攀搀 搀甀爀椀渀最 甀猀攀 漀昀 瀀漀氀椀搀漀挀愀渀漀氀 椀渀 眀漀爀氀搀ⴀ眀椀搀攀 攀砀瀀攀爀椀攀渀挀攀㬀 椀渀 猀漀洀攀 漀昀 琀栀攀猀攀 挀愀猀攀猀 琀栀攀猀攀 愀搀瘀攀爀猀攀 攀瘀攀渀琀猀 栀愀瘀攀 戀攀攀渀 猀攀爀椀漀甀猀 漀爀 琀爀漀甀戀氀攀猀漀洀攀⸀ 䈀攀挀愀甀猀攀 琀栀攀猀攀 爀攀愀挀琀椀漀渀猀 愀爀攀 爀攀瀀漀爀琀攀搀 瘀漀氀甀渀琀愀爀椀氀礀 昀爀漀洀 愀 瀀漀瀀甀氀愀琀椀漀渀 漀昀 甀渀挀攀爀琀愀椀渀 猀椀稀攀 愀渀搀 眀椀琀栀漀甀琀 愀 挀漀渀琀爀漀氀 最爀漀甀瀀Ⰰ 椀琀 椀猀 渀漀琀 瀀漀猀猀椀戀氀攀 琀漀 攀猀琀椀洀愀琀攀 琀栀攀椀爀 昀爀攀焀甀攀渀挀礀 爀攀氀椀愀戀氀礀 漀爀 琀漀 攀猀琀愀戀氀椀猀栀 愀 挀愀甀猀愀氀 爀攀氀愀琀椀漀渀猀栀椀瀀 琀漀 搀爀甀最 攀砀瀀漀猀甀爀攀⸀ഀഀ
਍㰀戀爀㸀ഀഀ Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma਍㰀戀爀㸀ഀഀ
਍㰀椀㸀一攀爀瘀漀甀猀 猀礀猀琀攀洀 搀椀猀漀爀搀攀爀猀㨀㰀⼀椀㸀 䌀攀爀攀戀爀漀瘀愀猀挀甀氀愀爀 愀挀挀椀搀攀渀琀Ⰰ 洀椀最爀愀椀渀攀Ⰰ 瀀愀爀攀猀琀栀攀猀椀愀 ⠀氀漀挀愀氀⤀Ⰰ 氀漀猀猀 漀昀 挀漀渀猀挀椀漀甀猀渀攀猀猀Ⰰഀഀ confusional state, dizziness਍㰀戀爀㸀ഀഀ
਍㰀椀㸀䌀愀爀搀椀愀挀 搀椀猀漀爀搀攀爀猀㨀㰀⼀椀㸀 䌀愀爀搀椀愀挀 愀爀爀攀猀琀Ⰰ 瀀愀氀瀀椀琀愀琀椀漀渀猀ഀഀ
਍㰀戀爀㸀ഀഀ Vascular disorders. Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse,਍瘀愀猀挀甀氀椀琀椀猀ഀഀ
਍㰀戀爀㸀ഀഀ Respiratory, thoracic and mediastinal disorders: Dyspnea਍㰀戀爀㸀ഀഀ
਍㰀椀㸀匀欀椀渀 愀渀搀 猀甀戀挀甀琀愀渀攀漀甀猀 琀椀猀猀甀攀 搀椀猀漀爀搀攀爀猀㨀㰀⼀椀㸀 匀欀椀渀 栀礀瀀攀爀瀀椀最洀攀渀琀愀琀椀漀渀Ⰰ 搀攀爀洀愀琀椀琀椀猀 愀氀氀攀爀最椀挀Ⰰ 栀礀瀀攀爀琀爀椀挀栀漀猀椀猀 ⠀椀渀 琀栀攀 愀爀攀愀ഀഀ of sclerotherapy) General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush Injury, poisoning and procedural complications: Nerve injury਍㰀⼀倀㸀ഀഀ ਍ഀഀ ਍㰀愀 渀愀洀攀㴀∀䐀刀唀䜀䤀一吀䔀刀䄀䌀吀䤀伀一匀∀㸀ഀഀ

਍一漀 搀爀甀最ⴀ搀爀甀最 椀渀琀攀爀愀挀琀椀漀渀猀 栀愀瘀攀 戀攀攀渀 猀琀甀搀椀攀搀 眀椀琀栀 䄀猀挀氀攀爀愀⸀ഀഀ

਍㰀戀㸀倀爀攀最渀愀渀挀礀㰀⼀戀㸀ഀഀ

਍倀爀攀最渀愀渀挀礀 䌀愀琀攀最漀爀礀 䌀⸀ 倀漀氀椀搀漀挀愀渀漀氀 栀愀猀 戀攀攀渀 猀栀漀眀渀 琀漀 栀愀瘀攀 愀渀 攀洀戀爀礀漀挀椀搀愀氀 攀昀昀攀挀琀 椀渀 爀愀戀戀椀琀猀 眀栀攀渀 最椀瘀攀渀 椀渀 搀漀猀攀猀 愀瀀瀀爀漀砀椀洀愀琀攀氀礀 攀焀甀愀氀 ⠀漀渀 琀栀攀 戀愀猀椀猀 漀昀 戀漀搀礀 猀甀爀昀愀挀攀 愀爀攀愀⤀ 琀漀 琀栀攀 栀甀洀愀渀 搀漀猀攀⸀ 吀栀椀猀 攀昀昀攀挀琀 洀愀礀 栀愀瘀攀 戀攀攀渀 猀攀挀漀渀搀愀爀礀 琀漀 洀愀琀攀爀渀愀氀 琀漀砀椀挀椀琀礀⸀ 吀栀攀爀攀 愀爀攀 渀漀 愀搀攀焀甀愀琀攀 愀渀搀 眀攀氀氀ⴀ挀漀渀琀爀漀氀氀攀搀 猀琀甀搀椀攀猀 椀渀 瀀爀攀最渀愀渀琀 眀漀洀攀渀⸀ 䄀猀挀氀攀爀愀 猀栀漀甀氀搀 渀漀琀 戀攀 甀猀攀搀 搀甀爀椀渀最 瀀爀攀最渀愀渀挀礀⸀ഀഀ

਍㰀甀㸀䄀渀椀洀愀氀 匀琀甀搀椀攀猀㰀⼀甀㸀ഀഀ

਍䐀攀瘀攀氀漀瀀洀攀渀琀愀氀 爀攀瀀爀漀搀甀挀琀椀瘀攀 琀漀砀椀挀椀琀礀 琀攀猀琀椀渀最 眀愀猀 瀀攀爀昀漀爀洀攀搀 椀渀 爀愀琀猀 愀渀搀 爀愀戀戀椀琀猀 眀椀琀栀 椀渀琀爀愀瘀攀渀漀甀猀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀⸀ 倀漀氀椀搀漀挀愀渀漀氀 椀渀搀甀挀攀搀 洀愀琀攀爀渀愀氀 愀渀搀 昀攀琀愀氀 琀漀砀椀挀椀琀礀 椀渀 爀愀戀戀椀琀猀Ⰰ 椀渀挀氀甀搀椀渀最 爀攀搀甀挀攀搀 洀攀愀渀 昀攀琀愀氀 眀攀椀最栀琀 愀渀搀 爀攀搀甀挀攀搀 昀攀琀愀氀 猀甀爀瘀椀瘀愀氀Ⰰ 眀栀攀渀 愀搀洀椀渀椀猀琀攀爀攀搀 搀甀爀椀渀最 最攀猀琀愀琀椀漀渀 搀愀礀猀 㘀ⴀ㈀　 愀琀 搀漀猀攀猀 漀昀 㐀 愀渀搀 ㄀　 洀最⼀欀最Ⰰ 戀甀琀 椀琀 搀椀搀 渀漀琀 挀愀甀猀攀 猀欀攀氀攀琀愀氀 漀爀 瘀椀猀挀攀爀愀氀 愀戀渀漀爀洀愀氀椀琀椀攀猀⸀ 一漀 愀搀瘀攀爀猀攀 洀愀琀攀爀渀愀氀 漀爀 昀攀琀愀氀 攀昀昀攀挀琀猀 眀攀爀攀 漀戀猀攀爀瘀攀搀 椀渀 爀愀戀戀椀琀猀 愀琀 愀 搀漀猀攀 漀昀 ㈀ 洀最⼀欀最⸀ 一漀 攀瘀椀搀攀渀挀攀 漀昀 琀攀爀愀琀漀最攀渀椀挀椀琀礀 漀爀 昀攀琀愀氀 琀漀砀椀挀椀琀礀 眀愀猀 漀戀猀攀爀瘀攀搀 椀渀 爀愀琀猀 搀漀猀攀搀 搀甀爀椀渀最 最攀猀琀愀琀椀漀渀 搀愀礀猀 㘀ⴀ㄀㜀 眀椀琀栀 搀漀猀攀猀 甀瀀 琀漀 ㄀　 洀最⼀欀最⸀ 倀漀氀椀搀漀挀愀渀漀氀 搀椀搀 渀漀琀 愀昀昀攀挀琀 琀栀攀 愀戀椀氀椀琀礀 漀昀 爀愀琀猀 琀漀 搀攀氀椀瘀攀爀 愀渀搀 爀攀愀爀 瀀甀瀀猀 眀栀攀渀 愀搀洀椀渀椀猀琀攀爀攀搀 椀渀琀攀爀洀椀琀琀攀渀琀氀礀 戀礀 椀渀琀爀愀瘀攀渀漀甀猀 椀渀樀攀挀琀椀漀渀 昀爀漀洀 最攀猀琀愀琀椀漀渀 搀愀礀 ㄀㜀 琀漀 瀀漀猀琀ⴀ瀀愀爀琀甀洀 搀愀礀 ㈀㄀ 愀琀 搀漀猀攀猀 甀瀀 琀漀 ㄀　 洀最⼀欀最⸀ഀഀ

਍㰀甀㸀䠀甀洀愀渀 匀琀甀搀椀攀猀㰀⼀甀㸀ഀഀ

਍吀栀攀爀攀 愀爀攀 渀漀 愀搀攀焀甀愀琀攀 愀渀搀 眀攀氀氀ⴀ挀漀渀琀爀漀氀氀攀搀 猀琀甀搀椀攀猀 漀渀 琀栀攀 甀猀攀 漀昀 䄀猀挀氀攀爀愀 椀渀 瀀爀攀最渀愀渀琀 眀漀洀攀渀⸀ഀഀ

਍㰀戀㸀䰀愀戀漀爀 愀渀搀 䐀攀氀椀瘀攀爀礀㰀⼀戀㸀ഀഀ

਍吀栀攀 攀昀昀攀挀琀猀 漀昀 䄀猀挀氀攀爀愀 漀渀 氀愀戀漀爀 愀渀搀 搀攀氀椀瘀攀爀礀 椀渀 瀀爀攀最渀愀渀琀 眀漀洀攀渀 愀爀攀 甀渀欀渀漀眀渀⸀ഀഀ

਍㰀戀㸀一甀爀猀椀渀最 䴀漀琀栀攀爀猀㰀⼀戀㸀ഀഀ

਍䤀琀 椀猀 渀漀琀 欀渀漀眀渀 眀栀攀琀栀攀爀 瀀漀氀椀搀漀挀愀渀漀氀 椀猀 攀砀挀爀攀琀攀搀 椀渀 栀甀洀愀渀 洀椀氀欀⸀ 䈀攀挀愀甀猀攀 洀愀渀礀 搀爀甀最猀 愀爀攀 攀砀挀爀攀琀攀搀 椀渀 栀甀洀愀渀 洀椀氀欀 愀渀搀 戀攀挀愀甀猀攀 漀昀 琀栀攀 瀀漀琀攀渀琀椀愀氀 昀漀爀 猀攀爀椀漀甀猀 愀搀瘀攀爀猀攀 爀攀愀挀琀椀漀渀猀 椀渀 渀甀爀猀椀渀最 椀渀昀愀渀琀猀Ⰰ 愀瘀漀椀搀 愀搀洀椀渀椀猀琀攀爀椀渀最 琀漀 愀 渀甀爀猀椀渀最 眀漀洀愀渀⸀ഀഀ

਍㰀戀㸀倀攀搀椀愀琀爀椀挀 唀猀攀㰀⼀戀㸀ഀഀ

਍吀栀攀 猀愀昀攀琀礀 愀渀搀 攀昀昀攀挀琀椀瘀攀渀攀猀猀 漀昀 䄀猀挀氀攀爀愀 椀渀 瀀攀搀椀愀琀爀椀挀 瀀愀琀椀攀渀琀猀 栀愀瘀攀 渀漀琀 戀攀攀渀 攀猀琀愀戀氀椀猀栀攀搀⸀ഀഀ

਍㰀戀㸀䜀攀爀椀愀琀爀椀挀 唀猀攀㰀⼀戀㸀ഀഀ

਍䌀氀椀渀椀挀愀氀 猀琀甀搀椀攀猀 漀昀 䄀猀挀氀攀爀愀 搀椀搀 渀漀琀 椀渀挀氀甀搀攀 猀甀昀昀椀挀椀攀渀琀 渀甀洀戀攀爀猀 漀昀 猀甀戀樀攀挀琀猀 愀最攀搀 㘀㔀 愀渀搀 漀瘀攀爀 琀漀 搀攀琀攀爀洀椀渀攀 眀栀攀琀栀攀爀 琀栀攀礀 爀攀猀瀀漀渀搀 搀椀昀昀攀爀攀渀琀氀礀 昀爀漀洀 礀漀甀渀最攀爀 猀甀戀樀攀挀琀猀⸀ഀഀ

਍伀瘀攀爀搀漀猀攀 洀愀礀 爀攀猀甀氀琀 椀渀 愀 栀椀最栀攀爀 椀渀挀椀搀攀渀挀攀 漀昀 氀漀挀愀氀椀稀攀搀 爀攀愀挀琀椀漀渀猀 猀甀挀栀 愀猀 渀攀挀爀漀猀椀猀⸀ഀഀ

਍䄀猀挀氀攀爀愀 椀猀 愀 猀琀攀爀椀氀攀Ⰰ 渀漀渀瀀礀爀漀最攀渀椀挀Ⰰ 愀渀搀 挀漀氀漀爀氀攀猀猀 琀漀 昀愀椀渀琀氀礀 最爀攀攀渀椀猀栀ⴀ礀攀氀氀漀眀 猀漀氀甀琀椀漀渀 漀昀 瀀漀氀椀搀漀挀愀渀漀氀 昀漀爀 椀渀琀爀愀瘀攀渀漀甀猀 甀猀攀 愀猀 愀 猀挀氀攀爀漀猀椀渀最 愀最攀渀琀⸀ഀഀ

਍吀栀攀 愀挀琀椀瘀攀 椀渀最爀攀搀椀攀渀琀Ⰰ 瀀漀氀椀搀漀挀愀渀漀氀 椀猀 愀 渀漀渀ⴀ椀漀渀椀挀 搀攀琀攀爀最攀渀琀Ⰰ 挀漀渀猀椀猀琀椀渀最 漀昀 琀眀漀 挀漀洀瀀漀渀攀渀琀猀Ⰰ 愀 瀀漀氀愀爀 栀礀搀爀漀瀀栀椀氀椀挀 ⠀搀漀搀攀挀礀氀 愀氀挀漀栀漀氀⤀ 愀渀搀 愀渀 愀瀀漀氀愀爀 栀礀搀爀漀瀀栀漀戀椀挀 ⠀瀀漀氀礀攀琀栀礀氀攀渀攀 漀砀椀搀攀⤀ 挀栀愀椀渀⸀ 倀漀氀椀搀漀挀愀渀漀氀 栀愀猀 琀栀攀 昀漀氀氀漀眀椀渀最 猀琀爀甀挀琀甀爀愀氀 昀漀爀洀甀氀愀㨀ഀഀ
਍㰀愀 渀愀洀攀㴀∀䌀䠀䔀䴀䤀䌀䄀䰀开匀吀刀唀䌀吀唀刀䔀∀㸀㰀⼀愀㸀ഀഀ ਍㰀戀爀㸀㰀戀爀㸀ഀഀ C12H25(OCH2CH2)nOH Polyethylene glycol monododecyl ether਍㰀戀爀㸀ഀഀ Mean extent of polymerization (n) : Approximately 9਍㰀戀爀㸀ഀഀ Mean molecular weight : Approximately 600਍㰀戀爀㸀㰀戀爀㸀ഀഀ Each mL contains 5 mg (0.5%) or 10 mg (1.0%) polidocanol in water for injection with 5% (v/v) ethanol at pH 6.5-8.0; disodium hydrogen phosphate dihydrate, potassium dihydrogen phosphate are added for pH adjustment.਍㰀⼀倀㸀ഀഀ ਍ഀഀ ਍㰀⼀愀㸀ഀഀ

਍㰀⼀倀㸀ഀഀ

਍䌀䰀䤀一䤀䌀䄀䰀 倀䠀䄀刀䴀䄀䌀伀䰀伀䜀夀ഀഀ

਍㰀戀㸀䌀愀爀挀椀渀漀最攀渀攀猀椀猀Ⰰ 䴀甀琀愀最攀渀攀猀椀猀Ⰰ 䤀洀瀀愀椀爀洀攀渀琀 漀昀 䘀攀爀琀椀氀椀琀礀㰀⼀戀㸀ഀഀ

਍䰀漀渀最ⴀ琀攀爀洀 猀琀甀搀椀攀猀 琀漀 攀瘀愀氀甀愀琀攀 挀愀爀挀椀渀漀最攀渀椀挀 瀀漀琀攀渀琀椀愀氀 栀愀瘀攀 渀漀琀 戀攀攀渀 挀漀渀搀甀挀琀攀搀 眀椀琀栀 瀀漀氀椀搀漀挀愀渀漀氀⸀ 倀漀氀椀搀漀挀愀渀漀氀 眀愀猀 渀攀最愀琀椀瘀攀 椀渀 戀愀挀琀攀爀椀愀氀 爀攀瘀攀爀猀攀 洀甀琀愀琀椀漀渀 愀猀猀愀礀猀 椀渀 匀愀氀洀漀渀攀氀氀愀 愀渀搀 䔀⸀ 挀漀氀椀Ⰰ 愀渀搀 椀渀 愀 洀椀挀爀漀渀甀挀氀攀甀猀 愀猀猀愀礀 挀漀渀搀甀挀琀攀搀 椀渀 洀椀挀攀⸀ 倀漀氀椀搀漀挀愀渀漀氀 椀渀搀甀挀攀搀 渀甀洀攀爀椀挀愀氀 挀栀爀漀洀漀猀漀洀愀氀 愀戀攀爀爀愀琀椀漀渀猀 椀渀 挀甀氀琀甀爀攀搀 渀攀眀戀漀爀渀 䌀栀椀渀攀猀攀 栀愀洀猀琀攀爀 氀甀渀最 昀椀戀爀漀戀氀愀猀琀猀 椀渀 琀栀攀 愀戀猀攀渀挀攀 漀昀 洀攀琀愀戀漀氀椀挀 愀挀琀椀瘀愀琀椀漀渀⸀ഀഀ

਍倀漀氀椀搀漀挀愀渀漀氀 搀椀搀 渀漀琀 愀昀昀攀挀琀 爀攀瀀爀漀搀甀挀琀椀瘀攀 瀀攀爀昀漀爀洀愀渀挀攀 ⠀昀攀爀琀椀氀椀琀礀⤀ 漀昀 爀愀琀猀 眀栀攀渀 愀搀洀椀渀椀猀琀攀爀攀搀 椀渀琀攀爀洀椀琀琀攀渀琀氀礀 愀琀 搀漀猀愀最攀猀 甀瀀 琀漀 ㄀　 洀最⼀欀最 ⠀愀瀀瀀爀漀砀椀洀愀琀攀氀礀 攀焀甀愀氀 琀漀 琀栀攀 洀愀砀椀洀甀洀 栀甀洀愀渀 搀漀猀攀 漀渀 琀栀攀 戀愀猀椀猀 漀昀 戀漀搀礀 猀甀爀昀愀挀攀 愀爀攀愀⤀⸀ഀഀ

਍㰀⼀愀㸀ഀഀ

਍㰀⼀倀㸀ഀഀ

਍䌀䰀䤀一䤀䌀䄀䰀 匀吀唀䐀䤀䔀匀ഀഀ

਍㰀倀㸀ഀഀ Asclera was evaluated in a multicenter, randomized, double-blind, placebo- and comparator-controlled trial (EASI-study) in patients with spider or reticular varicose veins. A total of 338 patients were treated with Asclera [0.5% for spider veins (N=94), 1% for reticular veins (N=86)], sodium tetradecyl sulfate (STS) 1% (N=105), or placebo (0.9% isotonic saline solution) (N=53) for either spider or reticular veins. Patients were predominately female, ranging in age from 19 to 70 years. All of them received an intravenous injection in the first treatment session; repeat injections were given three and six weeks later if the previous injection was evaluated as unsuccessful (defined as 1, 2 or 3 on a 5-point scale, see below). Patients returned at 12 and 26 weeks after the last injection for final assessments.਍㰀戀爀㸀㰀戀爀㸀ഀഀ The primary effectiveness endpoint was improvement of veins judged by a blinded panel. Digital images of the selected treatment area were taken prior to injection, compared with those taken at 12 weeks post-treatment, and rated on a 5-point scale (1 = worse than before, 2 = same as before, 3 = moderate improvement, 4 = good improvement, 5 = complete treatment success); results are shown in Table 2.਍㰀戀爀㸀㰀戀爀㸀ഀഀ ਍㰀戀爀㸀㰀戀爀㸀ഀഀ The secondary efficacy criterion was the rate of treatment success, pre-defined as a score of 4 or 5 with patients scoring 1, 2, or 3 considered treatment failures; results are shown in Table 3.਍㰀戀爀㸀㰀⼀甀氀㸀ഀഀ ਍㰀甀氀㸀㰀戀爀㸀ഀഀ At 12 and 26 weeks, patients’ judgment of the results was assessed by showing them the digital images of their treatment area taken at baseline and asking them to rate their satisfaction with their treatment using a verbal rating scale (1 = very unsatisfied; 2 = somewhat unsatisfied; 3 = slightly satisfied; 4 = satisfied and 5 = very satisfied); results are shown in Table 4.਍㰀戀爀㸀㰀⼀甀氀㸀ഀഀ ਍㰀甀氀㸀㰀戀爀㸀ഀഀ ਍㰀⼀倀㸀ഀഀ ਍ഀഀ ਍ഀഀ

਍䄀搀瘀椀猀攀 琀栀攀 瀀愀琀椀攀渀琀 琀漀 眀攀愀爀 挀漀洀瀀爀攀猀猀椀漀渀 猀琀漀挀欀椀渀最猀 漀爀 猀甀瀀瀀漀爀琀 栀漀猀攀 漀渀 琀栀攀 琀爀攀愀琀攀搀 氀攀最猀 挀漀渀琀椀渀甀漀甀猀氀礀 昀漀爀 ㈀ 琀漀 ㌀ 搀愀礀猀 愀渀搀 昀漀爀 ㈀ 琀漀 ㌀ 眀攀攀欀猀 搀甀爀椀渀最 琀栀攀 搀愀礀琀椀洀攀⸀ 䌀漀洀瀀爀攀猀猀椀漀渀 猀琀漀挀欀椀渀最猀 漀爀 猀甀瀀瀀漀爀琀 栀漀猀攀 猀栀漀甀氀搀 戀攀 琀栀椀最栀 漀爀 欀渀攀攀 栀椀最栀 搀攀瀀攀渀搀椀渀最 甀瀀漀渀 琀栀攀 愀爀攀愀 琀爀攀愀琀攀搀 椀渀 漀爀搀攀爀 琀漀 瀀爀漀瘀椀搀攀 愀搀攀焀甀愀琀攀 挀漀瘀攀爀愀最攀⸀ഀഀ

਍䄀搀瘀椀猀攀 琀栀攀 瀀愀琀椀攀渀琀 琀漀 眀愀氀欀 昀漀爀 ㄀㔀 琀漀 ㈀　 洀椀渀甀琀攀猀 椀洀洀攀搀椀愀琀攀氀礀 愀昀琀攀爀 琀栀攀 瀀爀漀挀攀搀甀爀攀 愀渀搀 搀愀椀氀礀 昀漀爀 琀栀攀 渀攀砀琀 昀攀眀 搀愀礀猀⸀ഀഀ

਍䘀漀爀 琀眀漀 琀漀 琀栀爀攀攀 搀愀礀猀 昀漀氀氀漀眀椀渀最 琀爀攀愀琀洀攀渀琀Ⰰ 愀搀瘀椀猀攀 琀栀攀 瀀愀琀椀攀渀琀 琀漀 愀瘀漀椀搀 栀攀愀瘀礀 攀砀攀爀挀椀猀攀Ⰰ 猀甀渀戀愀琀栀椀渀最Ⰰ 氀漀渀最 瀀氀愀渀攀 昀氀椀最栀琀猀Ⰰ 愀渀搀 栀漀琀 戀愀琀栀猀 漀爀 猀愀甀渀愀⸀ഀഀ

਍㰀⼀倀㸀ഀഀ

਍㰀戀㸀䐀椀猀琀爀椀戀甀琀攀搀 戀礀㨀㰀⼀戀㸀ഀഀ
਍㰀戀㸀㰀愀 栀爀攀昀㴀∀栀琀琀瀀㨀⼀⼀眀眀眀⸀戀椀漀昀漀爀洀⸀挀漀洀⼀∀ 琀愀爀最攀琀㴀∀开戀氀愀渀欀∀㸀䈀椀漀昀漀爀洀 䴀攀搀椀挀愀氀Ⰰ 䤀渀挀㰀⼀愀㸀㰀⼀戀㸀ഀഀ
਍㐀㄀㌀㌀ 䌀漀甀爀琀渀攀礀 刀漀愀搀Ⰰ 匀甀椀琀攀 ⌀㄀　ഀഀ
਍䘀爀愀渀欀猀瘀椀氀氀攀Ⰰ 圀䤀 㔀㌀㄀㈀㘀ഀഀ

[March 2010]਍㰀⼀倀㸀ഀഀ

਍㰀戀㸀䴀愀渀甀昀愀挀琀甀爀攀搀 戀礀㨀㰀⼀戀㸀ഀഀ
਍㰀戀㸀㰀愀 栀爀攀昀㴀∀栀琀琀瀀㨀⼀⼀眀眀眀⸀欀爀攀甀猀猀氀攀爀ⴀ挀栀攀洀椀攀⸀搀攀⼀椀渀搀攀砀⸀瀀栀瀀㼀猀瀀爀愀挀栀㴀攀∀ 琀愀爀最攀琀㴀∀开戀氀愀渀欀∀㸀䌀栀攀洀椀猀挀栀攀 䘀愀戀爀椀欀 䬀爀攀甀猀猀氀攀爀 ☀ 䌀漀⸀ 䜀洀戀䠀㰀⼀愀㸀㰀⼀戀㸀ഀഀ
਍㘀㔀㈀　㌀ 圀椀攀猀戀愀搀攀渀ഀഀ
਍䜀䔀刀䴀䄀一夀ഀഀ
਍䄀猀挀氀攀爀愀 椀猀 愀 琀爀愀搀攀洀愀爀欀 漀昀 䌀栀攀洀椀猀挀栀攀 䘀愀戀爀椀欀 䬀爀攀甀猀猀氀攀爀 ☀ 䌀漀⸀ 䜀洀戀䠀㰀⼀愀㸀Ⰰ 㘀㔀㈀　㌀ 圀椀攀猀戀愀搀攀渀Ⰰ 䜀䔀刀䴀䄀一夀ഀഀ