Stronger Iodine
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
PULMOZYME® (dornase alfa) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
In CF patients with an FVC ≥ 40% of predicted, daily administration of PULMOZYME has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.
History
There is currently no drug history available for this drug.
Other Information
PULMOZYME is a recombinant human deoxyribonuclease I (rhDNase) an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase). Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin, 100–200 mg/L. However, the presence of the antibiotic is not detectable in the final product. The product is purified by tangential flow filtration and column chromatography. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons. The primary amino acid sequence is identical to that of the native human enzyme.
PULMOZYME is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer or an approved nebulizer system [see Clinical Studies (14) and Dosage and Administration (2)]. PULMOZYME is a sterile, clear, colorless, highly purified solution in single-use ampules. Each ampule delivers 2.5 mL of the solution to the nebulizer bowl. Each mL of aqueous solution contains 1 mg dornase alfa, calcium chloride dihydrate (0.15 mg) and sodium chloride (8.77 mg). The solution contains no preservative. The nominal pH of the solution is 6.3.
Sources
Stronger Iodine Manufacturers
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Mwi/vet One
![Stronger Iodine (Iodine) Liquid [Mwi/vet One]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Stronger Iodine | Genentech, Inc.
2.1 Recommended DosageThe 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/compressor system or eRapid™ Nebulizer System.
Some patients may benefit from twice daily administration [see Clinical Studies (14)]
2.2 Directions for UseAdminister PULMOZYME via the eRapid Nebulizer System or via a jet nebulizer connected to an air compressor with an adequate air flow 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.
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.
Table 1 Recommended Jet Nebulizers/Compressors and Nebulizer Systems * Patients who are unable to inhale or exhale orally throughout the entire nebulization period may use the PARI BABY™ nebulizer. † Consisting of the eRapid™ Nebulizer Handset with eBase™ Controller. Jet Nebulizer Compressor Hudson T Up-draft II® with Pulmo-Aide® Marquest Acorn II® with Pulmo-Aide® PARI LC® Plus with PARI PRONEB® *PARI BABY™ with PARI PRONEB® Durable Sidestream® with MOBILAIRE™ Durable Sidestream® with Porta-Neb® Nebulizer System 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.
2.3 Storage and HandlingStore 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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