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

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

„Es gilt als gesichert, dass es beim französischen Luzenac-Talk (… Steritalc®, Novatech) zu keiner systemischen Talkumdissemination kommt.“
(“It is regarded secure that the French Luzenac talcum (… Steritalc®, Novatech) does not lead to a systemic talcum 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

STERITALC®

different forms of application:

STERITALC® 2 grams and 4 grams

  • For use as a slurry (to be mixed with physiological saline solution; Xylocain may be added).
  • For poudrage application via a thoracoscope / trocar.

STERITALC® 3 grams

  • For poudrage application via a thoracoscope / trocar (nebulization by air) in combination with NOVATECH® TALCAIR™.

NOVATECH® TALCAIR™

NOVATECH® TALCAIR™ is a powder blower, consisting of an insufflation cannula with attached coupling for the STERITALC® 3 grams vial and a separate insufflation bulb.

NOVATECH® TALCAIR™ is used in combination with STERITALC® 3 grams.

NOVATECH® TALCAIR™ has been especially designed for use with STERITALC® from Novatech, medical talcum intended for treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural effusion. The talcum is applied by poudrage through a thoracoscope.

NOVATECH® TALCAIR™ allows the talcum to take full effect, spreading it homo­geneously inside the pleural cavity. The aim is to create a “mist” in the pleural cavity, evenly ­distributing the talcum onto the parietal and visceral pleura.

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

Prescribing Information

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205555s000lbl.pdf