Dornase Alfa(Pulmozyme)
Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection
Formulation:
Inhalation solution
Validity period:
Use by expiration date on ampule.
Reminder: The outer packaging is for reference only, please purchase and use under the guidance of
a
pharmacist. For read by medical and pharmaceutical professionals only.
PULMOZYME® (dornase alfa) is a recombinant DNase enzyme formulated for inhalation. It works by enzymatically cleaving DNA in the sputum that accumulates in the airways of CF patients, thereby reducing the viscosity and elasticity of the mucus. This action helps to improve lung function and reduce the frequency of pulmonary exacerbations, significantly benefiting individuals with cystic fibrosis who suffer from chronic respiratory issues. The drug is administered using a nebulizer, with a typical dosage of 2.5 mg per day, although some patients may benefit from a higher frequency of administration (twice daily).
PULMOZYME® is a key component of cystic fibrosis therapy but should be used alongside other standard treatments like bronchodilators and antibiotics, as part of an individualized care regimen. It has been demonstrated in clinical trials to reduce pulmonary complications and improve respiratory outcomes in CF patients, making it an essential tool in the long-term management of the disease. However, proper administration and adherence to dosage instructions are critical to achieving the desired therapeutic outcomes.
Generic name
Dornase Alfa(Pulmozyme)
English name
Dornase Alfa
Alternative Names
Pulmozyme
Indications
Management of cystic fibrosis (CF) in pediatric and adult patients, in conjunction with standard therapies, to improve pulmonary function and reduce the risk of respiratory tract infections requiring parenteral antibiotics in patients with forced vital capacity (FVC) ≥40% of predicted.
Therapeutic Target
Hydrolysis of extracellular DNA in purulent CF sputum
Active Ingredients
Dornase alfa
Dosage form
Inhalation solution
specifications
30-unit cartons containing 5 foil pouches, each with 6 ampules. Each ampule: 2.5 mL solution (2.5 mg dornase alfa). NDC 50242-100-40.
Description
Dornase alfa is a recombinant glycoprotein (260 amino acids, ~37 kDa) produced in Chinese Hamster Ovary (CHO) cells. The solution is preservative-free, pH 6.3, and formulated for aerosol delivery via jet or vibrating mesh nebulizers.
Dosage and Administration
Standard Dose: 2.5 mg (one ampule) inhaled once daily.
Twice-Daily Use: Considered for patients with FVC >85% or age >21 years for enhanced efficacy.
Nebulizers: Approved systems include Hudson T Up-draft II®, PARI LC® Plus (jet), eRapid®, Innospire Go (vibrating mesh).
Pediatrics: PARI BABY™ with facemask for children unable to use a mouthpiece.
Instructions: Do not dilute/mix with other drugs; discard cloudy or discolored solutions.
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