Description

Pulmozyme (dornase alfa) solution for inhalation 2.5 mg/2.5 ml. ampoules №6

Ingredients

Active ingredient: Dornase alfa. Other ingredients: sodium chloride, calcium chloride dihydrate, polysorbate 80, and water for injection.

Dosage

Recommended dosage: The usual dose is 2.5 mg (1 ampoule) administered once daily via inhalation using a nebulizer.

Indications

Indicated for: Treatment of cystic fibrosis in patients aged 5 years and older to improve pulmonary function.

Contraindications

Do not use Pulmozyme if: You are allergic to dornase alfa or any of the ingredients in the product.

Directions

Administration: Administer the contents of one ampoule once daily using a recommended nebulizer device. Follow the instructions provided in the package insert.

Scientific Evidence

Pulmozyme (dornase alfa) has shown significant efficacy in improving lung function and reducing the frequency of respiratory exacerbations in patients with cystic fibrosis. Studies have demonstrated that regular use of dornase alfa can help decrease sputum viscosity, making it easier to clear mucus from the airways.

Additional Information

It is important to store Pulmozyme in the refrigerator between 2°C to 8°C (36°F to 46°F) and protect it from light. Do not freeze the solution. Discard any unused portion after 24 hours of opening the ampoule.

Pharmacological Effects

Dornase alfa, the active ingredient in Pulmozyme, is a recombinant human deoxyribonuclease enzyme that works by cleaving DNA in the thick mucus present in the airways of cystic fibrosis patients. This action helps to reduce the viscosity of the mucus, making it easier to clear and improving lung function.

Clinical Trials and Comparative Effectiveness

Clinical trials have shown that Pulmozyme is effective in improving lung function and reducing the risk of respiratory infections in patients with cystic fibrosis. Compared to other mucolytic agents, dornase alfa has been found to be more effective in improving pulmonary outcomes and quality of life in this patient population.

References:

• Ratjen F, et al. Dornase alfa in the treatment of cystic fibrosis in Europe: a report from the Epidemiologic Registry of Cystic Fibrosis. Pediatr Pulmonol. 2006;41(5):464-471.
• Elkins MR, et al. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006;354(3):229-240.