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Sclerosol (Talc Intrapleural) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Sclerosol® Intrapleural Aerosol, administered by aerosol during thoracoscopy or open thoracotomy, is indicated to prevent recurrence of malignant pleural effusions in symptomatic patients.

DOSAGE AND ADMINISTRATION

Sclerosol® Intrapleural Aerosol (sterile talc powder) is administered after adequate drainage of the effusion. It has been suggested that success of the pleurodesis is related to the completeness of the drainage of the pleural fluid, as well as full reexpansion of the lung, both of which will promote symphysis of the pleural surfaces.

The usual dosage of Sclerosol® Intrapleural Aerosol (sterile talc powder) is a single 4-8 g dose delivered intrapleurally from the spray canister (1-2 cans), which delivers talc at a rate of 1.2 g per second.

ADMINISTRATION PROCEDURE

Shake canister well before usage. Remove protective cap and securely attach actuator button with its delivery nozzle (either 15 cm or 25 cm) to the valve stem of canister.

Insert delivery nozzle through pleural trocar, taking care not to place the distal end of the delivery nozzle adjacent to the lung parenchyma or directly against the chest wall. While firmly holding the delivery nozzle and pleural trocar together in one hand, gently apply pressure to the actuator button on the canister. Sclerosol Intrapleural Aerosol® is not delivered by metered dose, but depends on the extent and duration of manual compression of the actuator button on the canister. The distal end of the delivery nozzle should be pointed in several different directions, while short bursts are administered in order to distribute the talc powder equally and extensively on all visceral and parietal pleural surfaces. For optimal distribution, always maintain the Sclerosol Intrapleural Aerosol® (sterile talc powder) canister in the upright position. After application, discard the canister and delivery nozzle. The duration of chest tube drainage following talc sclerosis is dictated by the clinical situation.

HOW SUPPLIED

NDC 63256-100-30: Sclerosol® Intrapleural Aerosol (sterile talc powder) contains 4 g of talc suspended in 25 g of inert propellant in a single-use aluminum canister. The canister is fitted with a continuous spray valve which delivers approximately 1.2 g of talc per second. This canister, attached to an actuator button, and two delivery nozzles of 15 cm and 25 cm length, are supplied in a sterile, flexible plastic peel pack.

STORAGE: Warning: Contents under pressure. Do not puncture or incinerate container. Store between 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) (see USP Controlled Room Temperature). Protect against sunlight and do not expose to a temperature above 49° C (120° F), or the canister may rupture. Avoid freezing. Shake well before using.

DISTRIBUTED BY: Bryan Corporation, Woburn MA 01801

October 2012

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