recommended [0.0001:<0.0001 compared to placebo. At 12 weeks (Visit 4) Yes 95% 92% 8% No 5% 8% 92% Missing 0.6% 0% 0% At 26 weeks (Visit 5) Yes 95% 91% 6% No 5% 9% 94% At 12 and 26 weeks, patients' judgement 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. Table 4: Patient satisfaction after 12 weeks and 26 weeks Polidocanol (N=155) STS (N=105) Placebo (N=53) * p> <0.0001 compared to STS and placebo Patient satisfaction with treatment after 12 weeks (Visit 4) Satisfied or very satisfied 87% * 64% 14% Patient satisfaction with treatment after 26 weeks (Visit 5) Satisfied or very satisfied 84% * 63% 16% How Supplied/Storage and Handling Asclera is supplied in single-use, preservative free ampules in the following packages: NDC 46783-121-52 Five 0.5% ampules (2 mL) NDC 46783-221-52 Five 1.0% ampules (2 mL) Each ampule is intended for immediate use in a single patient. Each unopened ampule is stable up to three years. Store at 15-30 C; (59-86 F). Patient Counseling Information Advise the patient to wear compression stockings or support hose on the treated legs continuously for 2 to 3 days and for 2 to 3 weeks during the daytime. Compression stockings or support hose should be thigh or knee high depending upon the area treated in order to provide adequate coverage. Advise the patient to walk for 15 to 20 minutes immediately after the procedure and daily for the next few days. For two to three days following treatment, advise the patient to avoid heavy exercise, sunbathing, long plane flights, and hot baths or sauna. Distributed by: Merz Aesthetics, Inc. 4133 Courtney Road, Suite #10 Franksville, WI 53126 Manufactured by: Chemische Fabrik Kreussler & Co. GmbH 65203 Wiesbaden GERMANY Asclera is a registered trademark of Chemische Fabrik Kreussler & Co. GmbH, 65203 Wiesbaden, GERMANY PRINCIPAL DISPLAY PANEL - 20 mg Carton NDC 46783-221-52 ASCLERA (polidocanol) Injection 20 mg per 2 mL (10 mg per mL) 1% For Intravenous Use Only Rx Only Single use: Discard unused portion Contains: 5 ampules each containing 20 mg per 2 mL PRINCIPAL DISPLAY PANEL - 10 mg Carton NDC 46783-121-52 ASCLERA (polidocanol) Injection 10 mg per 2 mL (5 mg per mL) 0.5% For Intravenous Use Only Rx Only Single use: Discard unused portion Contains: 5 ampules each containing 10 mg per 2 mL ASCLERA polidocanol injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:46783-221 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLIDOCANOL (POLIDOCANOL) POLIDOCANOL 0.01000 g in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL 0.04200 g in 1 mL POTASSIUM PHOSPHATE, MONOBASIC 0.00085 g in 1 mL SODIUM PHOSPHATE, DIBASIC 0.00240 g in 1 mL WATER 0.93875 g in 1 mL Packaging # Item Code Package Description 1 NDC:46783-221-52 2 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021201 06/01/2010 ASCLERA polidocanol injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:46783-121 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLIDOCANOL (POLIDOCANOL) POLIDOCANOL 0.00500 g in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL 0.04200 g in 1 mL POTASSIUM PHOSPHATE, MONOBASIC 0.00043 g in 1 mL SODIUM PHOSPHATE, DIBASIC 0.00120 g in 1 mL WATER 0.94437 g in 1 mL Packaging # Item Code Package Description 1 NDC:46783-121-52 2 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021201 06/01/2010 Labeler - Merz Aesthetics, Inc. (137113929) Establishment Name Address ID/FEI Operations Chemische Fabrik Kreussler & Co. GmbH 315568337 MANUFACTURE Revised: 09/2011 Merz Aesthetics, Inc. Next Pregnancy Warnings Print this page Add to My Med List More about polidocanol Side Effects During Pregnancy Dosage Information Compare Alternatives Support Group En Español 2 Reviews Add your own review/rating Drug class: sclerosing agents Consumer resources Laureth-9 polidocanol Polidocanol Polidocanol Intravenous (Advanced Reading) Professional resources Polidocanol (AHFS Monograph) Polidocanol (Wolters Kluwer) Other brands: Varithena , Asclera Related treatment guides Varicose Veins> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Sclerosing agents Related Drugs sclerosing agents Ethamolin , polidocanol , Sotradecol , Varithena , Asclera Varicose Veins polidocanol , Sotradecol , Varithena , Asclera , More... Polidocanol Rating 2 User Reviews 3.5 /10 2 User Reviews 3.5 Rate it! for boosting
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