Medically reviewed by Drugs.com. Last updated on Oct 21, 2020.
Generic name: DORNASE ALFA 1mg in 1mL
Dosage form: inhalation solution
The recommended dosage for use in most cystic fibrosis patients is one 2.5 mg single-use ampule inhaled once daily using a recommended jet nebulizer connected to an air compressor system or eRapid™ Nebulizer System.
Some patients may benefit from twice daily administration [see Clinical Studies (14)].
Directions for Use
Administer PULMOZYME via the eRapid Nebulizer System or via a jet nebulizer connected to an air compressor with an adequate air flow (compressor specifications: approximate air flow of 3.5 to 9 Liters per minute (L/min) at approximately 20 to 45 pounds per square inch (psi) pressure) and equipped with a mouthpiece or suitable face mask (see Table 1). No data are currently available to support the administration of PULMOZYME with other nebulizer systems.
For additional information, refer to recommended nebulizer manufacturers' Instructions for Use.
Do not 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.
|Hudson T Up-draft II®||Suitable compressor with the following specifications is recommended:
|Marquest Acorn II®|
|PARI LC® Plus|
|eRapid™ Nebulizer System‡|
The patient should follow the manufacturer's instructions on the use and maintenance of the equipment, including cleaning and disinfection procedures.
When PULMOZYME is administered with the eRapid Nebulizer System, advise patients to replace the handset after 90 uses, regardless of whether the EasyCare cleaning aid is used. Since delivery data are not available for PULMOZYME administered with the eRapid handset beyond 90 administrations, delivery of the appropriate therapeutic dose of PULMOZYME cannot be assured beyond 90 administrations. The eRapid Nebulizer System should only be used by adults and children who can use a mouthpiece, and not by younger children who need a mask to take PULMOZYME.
Storage and Handling
Store PULMOZYME ampules in their protective foil pouch under refrigeration and protected from light. Refrigerate ampules during transport and do not expose to room temperatures for a total time of 24 hours.
Each PULMOZYME ampule should be squeezed prior to use in order to check for leaks. Discard ampules if the solution is cloudy or discolored. Once opened, the entire contents of the ampule must be used or discarded.
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