ASCLERA- polidocanol injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

POLIDOCANOL (UNII: 0AWH8BFG9A) (POLIDOCANOL - UNII:0AWH8BFG9A)

Beschikbaar vanaf:

Methapharm, Inc

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Asclera® (polidocanol) is indicated to sclerose 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. Asclera has not been studied in varicose veins more than 3 mm in diameter. Asclera is contraindicated for patients with known allergy to polidocanol and patients with acute thromboembolic diseases. Risk Summary The available data from case reports on use of polidocanol-containing products, including ASCLERA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although none of these risks have been identified, there is minimal benefit in treating uncomplicated spider veins and reticular veins in the lower extremity during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum. The animal reproduction studies were conducted in a manner to achieve systemic e

Product samenvatting:

Asclera is supplied in single-use, preservative free ampules in the following packages: NDC 67850-140-05 Five 0.5% ampules (2 mL) NDC 67850-141-05 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).

Autorisatie-status:

New Drug Application

Productkenmerken

ASCLERA- POLIDOCANOL INJECTION, SOLUTION
METHAPHARM, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INDICATIONS AND USAGE
Asclera (polidocanol) is a sclerosing agent indicated to sclerose
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. Asclera has not been studied in varicose veins more than
3mm in diameter. (1)
DOSAGE AND ADMINISTRATION
For intravenous use only. Solution strength 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 METHAPHARM AT
1-866-701-4636 OR
[e-mail] OR FDA AT 1-800-FDA-1088 OR
www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAIN