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Getting Started with Mitosol

February 20, 2019 by MitosolAdmin


Mitosol, the only FDA approved mitomycin-c for ophthalmology. For those who may not be familiar with Mitosol here’s some information to help you make a smooth transition.

The Mitosol Kit

The Mitosol Kit

Mitosol is packaged as a complete kit with everything needed to safely deliver the proper concentration of mitomycin-c.

The Key Benefits:

  • Always there when you need it without refrigeration or light shielding and a long shelf life.
  • A safer system for handling MMC.
  • A more consistent concentration.
  • Will help healthcare facilities achieve USP <800> compliance.

Learn How to Safely Use Mitosol

We have a resource center available that includes all the necessary information for Mitosol application. Here’s a video with step-by-step instructions on using the Mitosol Kit.

More Mitosol Information

  • Mitosol Instruction Brochure (download 24 MB)
  • Mitosol Safety Data Sheet (download 1 MB)
  • Mitosol FAQs
  • USP Guidance (download 267 KB)

If you have questions or need help you can contact us at anytime. Customer Service 877-393-6486.

WMI-043 Rev 02/2021

Filed Under: Education Tagged With: News

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INDICATION

Mitosol® (mitomycin for solution) 0.2 mg/vial Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.

Dosage & Administration

Mitosol® is intended for topical application to the surgical site of glaucoma filtration surgery and must be reconstituted prior to application. Sponges provided within the Mitosol® kit should be fully saturated with the entire reconstituted contents in a manner prescribed in the Instructions For Use. The sponge(s) should be applied to the treatment area for two minutes. Reconstituted Mitosol® should be used within one hour of reconstitution.

US Patents #7,806,265, #8,186,511, #D685,962, #D685,963, #9,205,075, #9,539,241 and #9,649,428; other international patents issued and pending.

Product Information

Please click here for full Product Information for Mitosol®

IMPORTANT SAFETY INFORMATION
Contraindications

Mitosol® is contraindicated in patients that have demonstrated a hypersensitivity to mitomycin in the past.

Warnings & Precautions

Cell Death: Mitomycin is cytotoxic. Use of mitomycin in concentrations higher than 0.2 mg/mL or use for longer than 2 minutes may lead to unintended corneal and/or sclera damage including thinning or perforation. Direct contact with the corneal endothelium will result in cell death. Hypotony: The use of mitomycin has been associated with an increased instance of post-operative hypotony. Cataract Development: Use in phakic patients has been correlated to a higher instance of lenticular change and cataract formation. Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to use.

Adverse Events & Reactions

The most frequent adverse reactions to Mitosol® occur locally and include hypotony, hypotony maculopathy, blebitis, endophthalmitis, vascular reactions, corneal reactions, and cataract. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

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