INDICATIONS, SAFETY, AND WARNINGS Novapak™ Nasal Packing and Stent

INDICATIONS AND INTENDED USE

The Novapak™ Nasal Sinus Packing and Stent is intended for use in patients undergoing nasal/sinus surgery as a space-occupying stent to:

  • Separate tissue or structures compromised by surgical trauma.
  • Separate and prevent adhesions between mucosal surfaces in the nasal cavity.
  • Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption, and platelet aggregation.
  • Act as an adjunct to aid in the natural healing process.

Novapak™ Nasal Sinus Packing and Stent is indicated for use as a nasal packing to treat epistaxis.

CONTRAINDICATIONS AND WARNINGS

Patients with known shellfish allergies.

WARNINGS

  • Novapak™ contains chitosan from shellfish and should not be used in patients with known allergic responses to shellfish.
  • Physician should test for shellfish allergic response if status unknown, prior to use. In rare instances the physiochemical condition associated with Functional Endoscopic Sinus Surgery (FESS), both with and without material application, may present a risk of toxic shock syndrome (TSS). Warning signs of TSS include: sudden fever (usually 39°C or more), vomiting, diarrhea, dizziness, fainting (or near fainting when standing up) and/or a rash that looks like a sunburn.
  • Foreign body reaction may occur as with most surgical adjuvant treatments.
  • Novapak™ must be used according to the instructions for use. Read instructions prior to use.
  • Novapak™ performance has not been evaluated with pharmaceuticals.
  • Novapak™ Nasal Sinus Packing and Stent must be used according to the instructions for use. Read instructions prior to use.

PRECAUTIONS

  • Verify that the surgical field is not bleeding excessively. Control excessive bleeding, as you would normally, prior to application of the Novapak™ material.
  • Inspect the packaging to be sure that it is intact and undamaged prior to use. Do not use the product if the packaging is opened or damaged.
  • Do not reuse or resterilize Novapak™.
  • Thoroughly irrigate Novapak™ daily for best results to promote elimination. Failure to irrigate may result in incomplete dissolution.