PULMOZYME PULL-muh-zyme dornase alfa Instructions

PULL-muh-zyme dornase alfa

INSTRUCTIONS FOR USE
PULMOZYME® (PULL-muh-zyme)
(dornase alfa)
Inhalation Solution

This Instructions for Use contains information on how to use PULMOZYME with Jet Nebulizers and Compressors

See the other side of this Instructions for Use for information on use of Pulmozyme with the ultrasonic eRapid Nebulizer System

Read this Instructions for Use before you start taking Pulmozyme and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

A nebulizer and a compressor are used together to give a dose of Pulmozyme. A nebulizer changes the Pulmozyme liquid medicine into a fine mist you inhale by breathing through a mouthpiece. A compressor gives the nebulizer power and makes the nebulizer work.

Pulmozyme should only be used with the approved nebulizers and appropriate compressors as recommended below, or with the eRapid Nebulizer System (see other side of this Instructions for Use). Read and follow the manufacturer’s instructions.

Do not use any other inhaled medicines in the nebulizer at the same time. Keep all other inhaled medicine systems completely separate from Pulmozyme.

Use the mouthpiece or face mask provided with the nebulizer kit.

If your child cannot breathe in or breathe out by mouth, you may use the PARI BABY reusable nebulizer, but you should discuss it with your doctor first. The PARI BABY nebulizer is the same as the PARI LC Plus Jet system, except the mouthpiece is replaced by a tight-fitting face mask connected to an elbow piece.

Follow the steps on this side of the sheet to give Pulmozyme using the following jet nebulizer systems

For additional information on an appropriate compressor to use with Pulmozyme, read the manufacturer’s instructions for the recommended nebulizer.

Important Information You Need to Know Before Using PULMOZYME Supplies you will need to give a dose of Pulmozyme (See Figure A):

• 1 Pulmozyme ampule
• Compressor
• Nebulizer cup and cap (screw-on or snap-on)
• Plastic T (not needed for Sidestream nebulizer or PARI BABY)
• Flexible aerosol tube (not needed for Sidestream nebulizer or PARI BABY)
• Mouthpiece (clean) or PARI BABY facemask
• Long connecting tube Nose clip (optional, not needed for PARI BABY)

Taking your dose of Pulmozyme with a nebulizer:

• Replace the handset after you use your eRapid  Nebulizer System 90 times. Replace it even if you use the EasyCare cleaning aid.
• Your handset has been tested for only 90 doses of Pulmozyme. Delivery of the right dose of PULMOZYME cannot be certain after 90 doses.

How should I store Pulmozyme?

• Store Pulmozyme in its foil pouch in the refrigerator between 36°F to 46°F (2°C to 8°C) until you are ready to use it.
• When traveling, Pulmozyme should be kept cold.
• Protect Pulmozyme from excessive heat and light.
• Do not use Pulmozyme if it has been left at room temperature for a total time of 24 hours or if it becomes cloudy or discolored.
•  Do not use Pulmozyme past the expiration date printed on the ampule.

Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License No. 1048
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 07/2021

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