VARITHENA- polidocanol kit

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Biocompatibles, Inc.

INN (International Name):

POLIDOCANOL

Sammensætning:

POLIDOCANOL 180 mg in 1 mL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

VARITHENA (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities. The use of VARITHENA is contraindicated in patients with: - known allergy to polidocanol [see Warnings and Precautions (5.1)] - acute thromboembolic disease Risk Summary Few published case reports with use of polidocanol-containing products, including VARITHENA, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although no risks have been identified, there is minimal benefit in treating lower extremity varicosities during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum. In animal reproduction studies, no adverse develo

Produkt oversigt:

VARITHENA (polidocanol injectable foam) product is available in four configurations, each containing two sterile, connected, 303-mL aluminum alloy cylinders, one containing polidocanol solution (10 mg/mL) under carbon dioxide, and the other containing pressurized oxygen. Do not shake VARITHENA canisters. Avoid contact with eyes. Store the VARITHENA Bi-Canister or convenience box at or below 86°F (30°C); Do not refrigerate or freeze. Unused, non-activated VARITHENA canisters may be stored in the flat or upright position. Contains gas under pressure: May explode if heated. Store in a well-ventilated place. Store the canisters away from sources of heat including strong light conditions. Pressurized Oxygen: May cause or intensify fire; oxidizer. Store away from combustible materials. Once activated, the canister of 180 mg/18 mL (10 mg/mL) VARITHENA must be used within thirty (30) days. Once activated, the canister of 77.5mg/7.75mL (10mg/mL) VARITHENA must be used within thirty (30) days. Store activated canisters of VARITHENA upright, with the VARITHENA transfer unit attached, under the same temperature conditions as the VARITHENA Bi-Canister or convenience box. Use a new VARITHENA transfer unit for each treatment session. Discard aerosol canisters after use in accordance with state and local requirements. For more information, please refer to the IFU.

Autorisation status:

New Drug Application

Produktets egenskaber

VARITHENA- POLIDOCANOL
BIOCOMPATIBLES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VARITHENA® SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VARITHENA.
VARITHENA (POLIDOCANOL INJECTABLE FOAM), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
VARITHENA (polidocanol injectable foam) is a sclerosing agent
indicated for the treatment of incompetent
great saphenous veins, accessory saphenous veins, and visible
varicosities of the great saphenous vein
(GSV) system above and below the knee. VARITHENA improves the symptoms
of superficial venous
incompetence and the appearance of visible varicosities. (1).
DOSAGE AND ADMINISTRATION
Incompetent great saphenous or accessory saphenous veins: Use
Varithena 1% (CEAP Class 2-6
Disease). (2).
For intravenous use which should be performed under ultrasound
guidance when treating the GSV.
Use up to 5 mL per injection and 15 mL per treatment session. (2)
Separate treatment sessions by a minimum of 5 days. (2)
DOSAGE FORMS AND STRENGTHS
VARITHENA is supplied as polidocanol solution (10 mg/mL) in 18 mL or
7.75 mL; and must be activated
before use. (3)
Once activated, VARITHENA is a white, injectable foam delivering the
polidocanol solution. (3) Each mL of
VARITHENA injectable foam contains 1.3 mg of polidocanol.
CONTRAINDICATIONS
Known allergy to polidocanol (4)
Acute thromboembolic disease (4)
WARNINGS AND PRECAUTIONS
Be prepared to treat anaphylaxis. (5.1)
Tissue ischemia and necrosis: do not inject intra-arterially. (5.2)
Venous Thrombosis. (5.3)
ADVERSE REACTIONS
In clinical trials, the most common related adverse events (occurring
in ≥3% of patients treated with
VARITHENA) were pain/discomfort in extremity, infusion site thrombosis
(retained coagulum), injection site
hematoma or pain, thrombophlebitis superficial, and
extravasation.(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIOCOMPATIBLES, INC. AT
1-855-971-VEIN
(1-855-971-8346) OR FDA AT 1-800-FDA-1088 OR _