Controlled particle size talc for use in the pleural cavity
STERITALC® consists of talcum which is mined in France and is specifically processed for medical use (talcum pleurodesis).
STERITALC® is suited for all indications of pleurodesis. It is non-soluble and induces permanent pleurodesis. Compared with tetracyclines, talcum is more effective and less painful.
As a rule, for malignant indications 3 to 5 g are used, for treatment of spontaneous pneumothorax 2 g are sufficient in most cases.
A critical side effect of talcum pleurodesis can be ARDS (Acute Respiratory Distress Syndrome). A possible cause of ARDS may be the systemic dissemination of talcum. In some cases, after application in the pleural cavity, talcum was found in other organs (kidneys, spleen, liver), too. The literature assumes that there is a relation between the talcum particle size and the systemic dissemination of talcum: smaller talcum particles appear to disseminate more than larger ones1). The clinical picture also shows the effect of different particle sizes: talcum with a mean particle size below 15 µm induced stronger systemic and pulmonary inflammation reactions than talcum with a mean particle size of 25 µm.
STERITALC®, produced by Novatech, is specifically calibrated to a mean particle size of 25 µm in order to avoid systemic dissemination. Animal3) and clinical studies2) show the lesser systemic dissemination.
A multi-center study showed that STERITALC® with its calibrated particle size can be safely used for pleurodesis of malignant pleural effusions. None of more than 550 patients developed ARDS4). The authors recommend to use no other talcum.
Another cause of ARDS may be a sepsis due to unsterile talcum, or talcum containing endotoxines5). This, too, can be excluded when STERITALC® is used, because STERITALC® is free of endotoxines and comes sterile.
1) Ferrer, CHEST 2002; 122: 1018-1027
2) Maskell, Am .J. Respir. Crit. Care Med. 2004; 170: 377-382
3) Fraticelli, CHEST 2002; 122:1737-1741
4) Janssen, Lancet 2007; 369: 1535-1539
5) Antony, Eur. Respir. J. 2001; 18: 402-419
Three dosage forms
STERITALC® Vial F2, F4
- For use as a slurry (to be mixed with physiological saline solution; Xylocain may be added)
- For poudrage application via a thoracoscope / trocar
- For direct poudrage application via a thoracoscope / trocar (nebulization by aerosol)
- For direct poudrage application via a thoracoscope / trocar (nebulization by air)
- Ready to use – comes in a set with 3 g STERITALC®, a cannula and a balloon nebulizer.
Poudrage — creating a “mist”
The aim of using STERITALC® PF3 for poudrage is to create a “mist” in the pleural cavity, evenly distributing the talcum onto the parietal and visceral pleura.
Quantity of medical talc
Items / box
STERITALC® F2: Vial, 50 ml
STERITALC® F4: Vial, 50 ml
STERITALC® Spray, with cannula, L: 440 mm, OD: 2.1 mm
STERITALC® PF3: Vial 10 ml, with balloon and cannula, L: 420 mm, OD: 3.0 mm
Supplement for 16863: