Collanex Prescribing Information
Package insert / product label
Generic name: bovine type i collagen
Dosage form: transdermal powder
On This Page
Five Vials, 1g each
Collagen Particles
Triple Helical Matix
Conforms to FDA Quality System Requirements.
Manufactured as per cGMP standards.
Collanex Description
- This device is intended for single use only.
- All open and unused portions must be discarded.
- Sterility guaranteed in unopened, undamaged package only.
- Store in a cool and dry place.
Collanex Dosage and Administration
- Cleanse the wound.
- Apply medication to the wound if indicated.
- Apply Collanex™ Particles 1/4 inch thick to the wound surface. Do not pack tightly; allow for expansion of particles.
- Cover with non-stick dressing.
- Use Collanex™ Particles until wound is fully healed.
- Maintain a moist wound environment.
Product Removal
- Change as indicated by the amount of drainage and instructions provided with the absorbent cover dressing.
- After removal of the cover dressing, repeat steps under Product Application as needed.
Precautions
- Wounds may appear to be larger during the first several days of treatment due to the reduction of swelling.
- An increase in drainage may be seen in the first several days of treatment.
- The product is made from bovine materials. Do not use if you have an allergy to bovine derived materials (milk, beef products, leather, etc.)
- Warnings: Discontinue use of Collanex™ Particles and notify your doctor if excessive redness, pain, swelling or blistering occurs.
- All open and unused portions must be discarded.
- Warnings: Potencial risk of loss of sterility and infection if opened and reused.
RX Only
Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186
Made in the USA
800-442-7882
STRATUS
PHARMACEUTICALS INC
Reorder 5898075405
Rev1, 062021
PRINCIPAL DISPLAY PANEL - 1 g Vial Carton
COLLANEX™
Collagen Particles
Five Vials, 1g each
Collagen Particles
Triple Helical Matix
Conforms to FDA Quality System Requirements.
Manufactured as per cGMP standards.
Product Information:
- This device is intended for single use only.
- All open and unused portions must be discarded.
- Sterility guaranteed in unopened, undamaged pack-
age only. - Store in a cool and dry place.
RX Only
Five Vials, 1g each
STRATUS
PHARMACEUTICALS INC
Reorder 5898075405
COLLANEX COLLAGEN PARTICLES
dressing, wound, collagen powder |
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Labeler - STRATUS PHARMACEUTICALS INC (789001641) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Human BioSciences Inc | 014511541 | MANUFACTURE, LABEL |