Rx Item-Asclera Polidocanol 1% Ampoules 10MG/ML 5X2ML BY Metha Pharma

These highlights do not include all the information needed to use Asclera � Injection safely and effectively. See full prescribing information for Asclera. Asclera (polidocanol) Injection, for intravenous use Initial U.S. Approval: 2010 RECENT MAJOR CHANGES Warnings and Precautions, Venous Thrombosis and Pulmonary Embolism (5.2) 02/2018 Warnings and Precautions, Arterial Embolism (5.3) 02/2018 Warnings and Precautions, Tissue Ischemia and Necrosis (5.4) 02/2018 INDICATIONS AND USAGE Asclera (polidocanol) is a sclerosing agent indicated to treat uncomplicated spider veins (varicose veins ?1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. It has not been studied in larger varicose veins > 3 mm in diameter. (1) DOSAGE AND ADMINISTRATION For intravenous use only. The strength of the solution and the volume injected depend on the size and extent of the varicose veins. Extensive varicosities may require multiple treatment sessions. (2) Spider veins (varicose veins ?1 mm in diameter): Use Asclera 0.5%. (2) Reticular veins (varicose veins 1 to 3 mm in diameter): Use Asclera 1%. (2) Use 0.1 to 0.3 mL for each injection into each varicose vein. The maximum recommended volume per treatment session is 10 mL. (2) DOSAGE FORMS AND STRENGTHS 0.5% and 1% solution in 2 mL glass ampules. (3) CONTRAINDICATIONS Known allergies to polidocanol. (4) Patients with acute thromboembolic diseases. (4) WARNINGS AND PRECAUTIONS Be prepared to treat anaphylaxis. (5.1) Venous Thrombosis and Pulmonary Embolism. (5.2) Arterial Embolism. (5.3) Tissue ischemia and necrosis: Do not inject intra-arterially. (5.4) ADVERSE REACTIONS The most common adverse reactions occurring at least 3% more frequently than on placebo are mild local reactions at the site of injection. (6) To report SUSPECTED ADVERSE REACTIONS, contact Merz North America, Inc. at 1-844-469-6379 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 2/2018

ASCLERA 1% 10MG/ML 5X2ML DIR
ASCLERA POLIDOCANOL 1% AMPOULES 10MG/ML 5X2ML 10mg/ml =20mg/2ml by Metha Pharm NDC No. NEW 67850-0141-50 67850-141-50 6785014150 67850014150 OLD 46783-0221-52 46783-221-52 4678322152 46783022152

ASCLERA 1% 10MG/ML 5X2ML DIR
ASCLERA POLIDOCANOL 1% AMPOULES 10MG/ML 5X2ML 10mg/ml =20mg/2ml by Metha Pharm NDC No. NEW 67850-0141-50 67850-141-50 6785014150 67850014150 OLD 46783-0221-52 46783-221-52 4678322152 46783022152

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