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Mitosol

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Mitosol

PATIENT INFORMATION

Mitosol®
mitocycin for solution 0.2 mg/vial

Read INSTRUCTIONS FOR USE Before Proceeding

Instructions for Use

A. Black Outer Pack (Figure A)

One Chemotherapy Waste Bag
One Instructions for Use
One Package Insert
One Inner Tray

Black Outer Pack - Illustration

The Black Outer Pack is to be handled opened, and its STERILE contents dispensed by the non-sterile circulating nurse.

B. STERILE Inner Tray (Figure B)

One   Vial containing 0.2 mg mitomycin
One   1 mL syringe (Sterile Water For Injection) with Connector
One   Plunger Rod
One   Vial Adapter with Spike
One   1 mL TB Syringe, Luer Lock
One   Sponge Container
Six   3 mm Absorbent Sponges
Six   6 mm Absorbent Sponges
Six   Half Moon Sponges
One   Instrument Wedge Sponge
One   Alcohol Prep Pad, Sterile
One   Chemotherapy Waste Bag

Sterile Inner Tray - Illustration

The Sterile Inner Tray is to be handled, opened, and its Contents assembled and dispensed by the sterile scrub technician. This tray and its contents are STERILE.

1. Getting Started

Non-Sterile Circulating Nurse:

Open black outer pack. Affect sterile transfer of contents to the sterile field.

Sterile Surgical Technician:

Open sterile inner tray.

2. Reconstituting Mitosol®

    1. Screw white plunger rod to rubber plunger of pre-filled syringe. (Fig. 1)
    2. Screw white plunger rod - illustration

    3. Press firmly and screw the blue end of the vial adapter into the blue end of the syringe connector. (Fig. 2)
    4. Press firmly and screw the blue end - illustration

    5. Open and remove alcohol prep pad. Remove vial cap; disinfect vial stopper with alcohol prep pad.
    6. Holding vial face up, push spiked end of vial adapter down on the vial lid until seated and secure. (Fig. 3)
    7. Push spiked end of vial adapter down - illustration

    8. Inject entire contents of sterile water (1 ml) into vial. (Fig. 4)
    9. Inject entire contents - illustration

    10. Gently swirl vial and contents until complete reconstitution of Mitosol®. If product does not dissolve immediately, allow to stand at room temperature until the product has dissolved into solution.

3. Preparing sponges

  1. Invert vial and syringe and draw full volume of medication into syringe.
  2. Invert vial and syringe - illustration

  3. Unscrew the syringe and connector from vial and vial adapter (Fig. 6)
  4. Invert vial and syringe - illustration

  5. Place vial and vial adaptor in chemotherapy waste disposal bag (yellow bag).
  6. Take sponge container from sterile inner tray.
  7. Screw both syringes into sponge container; the TB syringe to one end, the pre-filled syringe to the other.
  8. Mitosol® must be used within 1 hour of reconstitution:
    • Inject medication into sponge container, saturating sponges. Reconstituted Mitosol® should remain undisturbed in sponge container for 60 seconds. (Fig. 7)
    • Inject medication into sponge container - illustration

    • If any excess fluid remains, withdraw plunger of TB syringe, drawing excess fluid/air into syringe.

4. Using Mitosol®

  1. With both syringes connected, the TB syringe to one end, the pre-filled syringe to the other, open sponge container, offering contents to surgeon for placement on surgical site. (Fig. 8)
  2. Open sponge container - illustration

  3. Apply saturated sponges to surgical site for two minutes. Remove sponges from eye and copiously irrigate surgical site.
  4. As used sponges are removed from surgical site, accept back into container for disposal. Close container lid.
  5. With syringes still connected to sponge container, remove entire assembly from surgical field in chemotherapy waste disposal bag.

DISPOSE OF CHEMOTHERAPY WASTE BAG AND ITS CONTENTS AS CHEMOTHERAPY WASTE

Last reviewed on RxList: 2/22/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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