Pulmozyme (Page 3 of 5)
16 HOW SUPPLIED/STORAGE AND HANDLING
PULMOZYME (dornase alfa) inhalation solution is a sterile, clear, colorless solution supplied in:
- 30 unit cartons containing 5 foil pouches of 6 single-dose ampules. Each 2.5 mL ampule contains 2.5 mg of dornase alfa (1 mg/mL): NDC 50242-100-40.
Storage and Handling
Store PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat. Once the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat. Do not use beyond the expiration date stamped on the ampule. During transport, keep the ampules refrigerated in their protective foil pouch to protect from light and heat. Do not use if the ampules are exposed to room temperature (22°C to 28°C [72°F to 82°F]) for more than a total of 60 hours. Avoid excessive heat and light.
17 PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Instructions for Use).
Preparation
Advise patients to squeeze each ampule prior to use in order to check for leaks. The solution should be discarded if it is cloudy or discolored. Once opened, the entire contents of the ampule must be used or discarded [see Dosage and Administration (2.2)].
Drug Incompatibilities
Instruct patients not to dilute or mix PULMOZYME with other drugs in the nebulizer. Mixing of PULMOZYME with other drugs could lead to adverse physicochemical and/or functional changes in PULMOZYME or the admixed compound [see Dosage and Administration (2.2)].
Storage
Instruct patients on the proper techniques to store and handle PULMOZYME [see How Supplied/Storage and Handling (16)].
Manufacturer’s Instruction Manual
Instruct patients to read and follow the manufacturer’s instruction manual for the proper use and maintenance of the jet nebulizer/compressor system, or the vibrating mesh nebulizer used in PULMOZYME delivery.
Pulmozyme® (dornase alfa)
Inhalation Solution
Manufactured by:
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License No. 1048
©2024 Genentech, Inc. All rights reserved
©2024 Genentech, Inc.Pulmozyme® is a registered trademark of Genentech, Inc.
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 recommended vibrating mesh nebulizers
Read and understand this Instructions for Use and the nebulizer manufacturer’s instruction manual 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 recommended vibrating mesh nebulizers (see other side of this Instructions for Use). Read and follow the manufacturer’s instruction manual.
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 Instructions for Use to give Pulmozyme using the following jet nebulizer systems
Jet Nebulizer | Compressor |
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Hudson T Up-draft II | A compressor with the following specifications is recommended:
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Marquest Acorn II | |
PARI LC Plus | |
PARI BABY | |
Durable Sidestream |
For additional information on an appropriate compressor to use with Pulmozyme, read the manufacturer’s instruction manual for the recommended nebulizer.
Important Information You Need to Know Before Using PULMOZYME
Read and follow the nebulizer manufacturer’s instruction manual for correct use and maintenance:
- to clean the nebulizer before first use and after each use as recommended.
- to disinfect the nebulizer parts by using the disinfecting method recommended.
- to replace nebulizer parts as recommended.
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)
Preparing the jet nebulizer and compressor:Step 1. Clean a flat table surface and wash your hands.
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Step 2. Gather the nebulizer and test the compressor.
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Step 3. Gather the Pulmozyme ampule and check the expiration date.
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Step 4. Check the Pulmozyme ampule.
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Step 5. Attach the long connecting tube to the compressor.
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Step 6. Attach the mouthpiece.
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Step 7. Remove the cap from the cup.
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Step 8. Open the Pulmozyme ampule.
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Step 9. Pour the full Pulmozyme dose into the nebulizer cup. | |
Step 10. Connect the plastic T.
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Step 11. Attach the long connecting tube to the cup.
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Step 12. Turn on the compressor.
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Taking your dose of Pulmozyme with a nebulizer: | |
Step 13. Breathe through the mouthpiece.
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If you are using the PARI BABY nebulizer to give Pulmozyme to your child, follow the instructions below in Step 14. If not, go to Step 15Step 14. Breathing through the facemask. | |
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It is important that your child inhale the full dose of Pulmozyme. If you find a leak or feel moisture coming from the nebulizer during the treatment, turn off the compressor and make sure the nebulizer cap is sealed correctly before starting the compressor again (See Figure X). | |
After your treatment with Pulmozyme:Step 15. Prepare the nebulizer for cleaning and storage.
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How should I store Pulmozyme?
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Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990US License No. 1048
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 02/2024
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.