STERITALC®

The only talcum pleurodesis product available in the US.

(talc) powder, for intrapleural use, indicated to decrease recurrence of malignant pleural effusions and pneumothorax

  • Granulometrically controlled talc
  • Sterile
  • Asbestos-free
  • Endotoxin-free

STERITALC® has been the standard of care for decades. Thousands of patients worldwide have been successfully treated with STERITALC®.

It is the only talc-based pleurodesis product with a well-documented and proven track record of safety and efficacy.

21 clinical studies from16 countries involving 2486 patients over a period of  25 years

„Es gilt als gesichert, dass es beim französischen Luzenac-Talk (… Steritalc®, Novatech) zu keiner systemischen Talkumdissemination kommt.“
“It is accepted as certain that the French Luzenac talc (… STERITALC®, NOVATECH) does not result in a systemic talc dissemination.”
Schnyder / Tschopp: Behandlung des Pneumothorax mittels internistisch-thorakoskopischer Talkumpleurodese. Der Pneumologe 2010. 7: 357-363

“The most important clinical implication of our study is that large-particle talc can safely be used for pleurodesis. Other talc preparations should not be used for this indication.”
Janssen et al.: Safety of pleurodesis with talc poudrage in malignant pleural effusion:a prospective cohort study. Lancet 2007; 369: 1535-1539

Excerpt from the US Prescribing Information for STERITALC®:


There are published reports of two large, prospective trials conducted to evaluate the safety of STERITALC® administered intrapleurally. One trial evaluated 558 patients treated with STERITALC® 4 g by poudrage for MPE. The second trial evaluated 418 patients with recurrent primary spontaneous pneumothorax treated with STERITALC® 2 g by poudrage.
No cases of ARDS or talc-related lung injury were reported.


 

Preventing systemic spread – preventing ARDS.

STERITALC® consists of talcum which is mined in France and is specifically processed for medical use (talcum pleurodesis).

STERITALC® is intended for treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural effusion. It is non-soluble and induces permanent pleurodesis. Compared with tetracyclines, talcum is more effective1,2.

For malignant indications 2 to 5 g are used, for treatment of pneumothorax 1 to 2 g are used.

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 even in other organs (kidneys, spleen, liver)3,4.

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 ones5.

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 μm6.

STERITALC®, produced by Novatech SA, France, is specifically calibrated in order to avoid systemic dissemination. Animal7 and clinical studies8 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 ARDS9. The authors recommend to use no other talcum.

Another cause of ARDS may be a sepsis due to unsterile talcum, or talcum containing endotoxines10. STERITALC® is free of endotoxines and comes sterile.


1 Noppen et al 1997, Acta Clin Belg. 1997; 52(5): 258-62
2 Hamed et al 1989, Br. J. Surg. 1989; Vol. 76, December 1266-1267
3 Fraticelli et al 2002, Chest 2002; 122: 1737-1741
4 Ferrer et al 2002, Chest 2002; 122: 1018-1027
5 Ferrer et al 2002, Chest 2002; 122: 1018-1027
6 Maskell, Am .J. Respir. Crit. Care Med. 2004; 170: 377-382
7 Fraticelli et al 2002, Chest 2002; 122: 1737-1741
8 Maskell, Am. J. Respir. Crit. Care Med. 2004; 170: 377-382
9 Janssen, Lancet 2007; 369: 1535-1539
10 Antony, Eur. Respir. J. 2001; 18: 402-419

Ordering Information STERITALC®

REF

STERITALC®

 

NDC-62327-222-42

2 grams


4 vials per carton
 

NDC-62327-333-43

3 grams

NDC-62327-444-44

4 grams

Ordering Information NOVATECH® TALCAIR™

REF

NOVATECH® TALCAIR™

 

109001T

Powder Blower
for STERITALC® 3 grams
(REF NDC-62327-333-43)

2 items per carton

Follow this link for more information about NOVATECH® TALCAIR™