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Respiratory Drug Data - A-Z (English)

Drug Class Description

rhDNase.

Generic Name

Dornase alfa

Drug Description

Each ampoule contains 2500 U (corresponding to 2.5mg) of dornase alfa* per 2.5ml corresponding to 1000 U/ml or 1mg/ml**. *phosphorylated glycosylated protein human deoxyribonuclease 1 produced in Chinese Hamster Ovary Cell Line CHO A14.16-1 MSB #757 by recombinant DNA technology **1 Genentech unit/ml = 1µg/ml

Presentation

Nebuliser solution Clear, colourless to slightly yellowish solution

Indications

Management of cystic fibrosis patients with a forced vital capacity (FVC) of greater than 40% of predicted and over 5 years of age to improve pulmonary function.

Adult Dosage

2.5mg (corresponding to 2500 U) deoxyribonuclease l by inhalation once daily. Inhale the contents of one ampoule (2.5ml of solution) undiluted using a recommended jet nebuliser/compressor system.

Some patients over the age of 21 years may benefit from twice daily dosage.

Most patients gain optimal benefit from regular daily use of Pulmozyme. In studies in which Pulmozyme was given in an intermittent regimen, improvement in pulmonary function was lost on cessation of therapy. Patients should therefore be advised to take their medication every day without a break.

Patients should continue their regular medical care, including their standard regimen of chest physiotherapy.

Administration can be safely continued in patients who experience exacerbation of respiratory tract infection.

Safety and efficacy have not yet been demonstrated in patients under the age of 5 years, or in patients with forced vital capacity less than 40% of predicted.

Child Dosage

Under 5 years, not recommended; over 5 years, same as adult.

Contra Indications

Hypersensitivity to the active substance or to any of the excipients.

Special Precautions

Pregnancy, lactation.

Interactions

Pulmozyme can be effectively and safely used in conjunction with standard cystic fibrosis therapies such as antibiotics, bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, and analgesicsDo not mix with other drugs in nebuliser.

Adverse Reactions

Pregnancy

The safety of dornase alfa has not been established in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, or embryofoetal development. Caution should be exercised when prescribing dornase alfa to pregnant women.

 

Lactation

As it is not known whether dornase alfa is excreted in human milk, caution should be exercised when dornase alfa is administered to a breast-feeding woman

Manufacturer

Roche Products Limited

Drug Availability

(POM)

Updated

09 June 2009

Drug Languages: en it fr de es no nl pt se

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