英文商品名:CALDESENE POWDER(SCLEROSOL GENERIC) 5oz/bottle

英文药品名:TALC

中文商品名:CALDESENE粉剂(司兰索仿制药) 5盎司/瓶

中文药品名:滑石粉

适应病症：恶性肿瘤性胸腔积液、恶性肿瘤、肿瘤、癌症

Sclerosol Intrapleural Aerosol：治疗恶性胸腔积液; Bryan Corporation生产; 1998年1月批准上市

Generic Name: sterile talc

Dosage Form: Powder

Sclerosol Description

Sclerosol® Intrapleural Aerosol (sterile talc powder 4 g) is a sclerosing agent for intrapleural administration supplied as a single-use, pressurized spray canister with two delivery tubes of 15 cm and 25 cm in length. Each canister contains 4.0 g of talc, either white or off-white to light grey, asbestos-free, and brucite-free grade of talc of controlled granulometry. The composition of the talc is ≥ 95% talc as hydrated magnesium silicate. The empirical formula is Mg3 Si4 O10 (OH)2 with molecular weight of 379.3. Associated naturally occurring minerals include chlorite (hydrated aluminum and magnesium silicate), dolomite (calcium and magnesium carbonite), calcite (calcium carbonate) and quartz. Talc is practically insoluble in water, and in dilute solutions of acids and alkali hydroxides. The canister and delivery tubes have been sterilized by gamma irradiation. The aerosol propellant contained in Sclerosol® Intrapleural Aerosol is dichlorodifluoromethane (CFC-12) with 26 g present per canister. The canister delivers 0.4 g of talc per second through the valve and the product contains no other excipients.

Mechanism of Action:

The therapeutic action of talc instilled into the pleural cavity is believed to result from induction of an inflammatory reaction. This reaction promotes adherence of the visceral to the parietal pleura, obliterating the pleural space and preventing reaccumulation of pleural fluid. The extent of talc systemically absorbed after intrapleural administration has not been adequately studied. Systemic exposure could be affected by the integrity of the visceral pleura, and therefore could be increased if talc is administered immediately following lung resection or biopsy.

Clinical Studies

The data demonstrating safety and efficacy of talc in the treatment of malignant pleural effusions are derived from the published medical literature. The following four trials were prospective, randomized studies of talc vs. a concurrent control, and provide sufficient detail for evaluation, including a clear, readily determined definition of response (no fluid reaccumulation by chest roentgenogram at one month or greater) and information allowing an analysis of all patients randomized. Talc was statistically significantly superior to the control arms in evaluable patients across the studies.

Indications and Usage for Sclerosol

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

Contraindications

None known.

Warnings

None.

Adverse Reactions

Talc administration has been described in more than 1500 patients reported in the medical literature. Patients with malignant pleural effusions were treated with talc via poudrage or slurry. In general, with respect to reported adverse experiences, it is difficult to distinguish the effects of talc from the effects of the procedure(s) associated with its administration. The most reported common adverse experiences were fever and pain. Almost all of the cases of fever, and over half of the cases of pain, were in patients who received diagnostic biopsies at the time of talc administration.

STORAGE

Warning: Contents under pressure. Do not puncture or incinerate container. Store between 59°F - 86°F (15°C - 30°C). Protect against sunlight and do not expose to a temperature above 120° F (49° C), or the canister may rupture. Avoid freezing. Shake well before using.