Dornase alfa
Therapeutic Dornase alfa enzyme from the original Pulmozime® commercial drug.
Reference Standard as Aliquots
Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot | Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2023.12 |
Pulmozyme® DE |
0.3 mg |
Unit: aliquot(s) |
188,00 €
/aliquot
|
Biosimilars as Aliquots
Access Batch Specific Analytical Information
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Product Information
Here you will find the product information for the reference product.
Pulmozyme® / Dornase Alfa Reference Product
| Drug name | Pulmozyme® |
| INN | Dornase Alfa |
| API type | Dornase Alfa is an enzyme produced by recombinant DNA technology. |
| Pharmacotherapeutic group | Respiratory system |
| ATC code | R05CB13 |
| Target | DNA in cystic fibrosis mucus |
| General function | |
| Short description | 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. |
| Pharmacodynamic properties (Mechanism of action; Source EMC document) | Recombinant human DNase is a genetically engineered version of a naturally occurring human enzyme which cleaves extracellular DNA. Retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent secretions contain very high concentrations of extracellular DNA, a viscous polyanion released by degenerating leukocytes, which accumulate in response to infection. In vitro, dornase alfa hydrolyses DNA in sputum and greatly reduces the viscoelasticity of cystic fibrosis sputum. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMC document) | Inhalation studies conducted in rats and non-human primates show a low percentage of dornase alfa systemic absorption, < 15% for rats and < 2% for monkeys. Consistent with the results of these animal studies, dornase alfa administered to patients as an inhaled aerosol shows low systemic exposure. Absorption of dornase alfa from the gastrointestinal tract following oral administration to rats is negligible. |
| Original license holder | |
| Marketing authorisation numbers | 30289.00.00 (German authorisation number) |
| Marketing authorisation holder | Roche Pharma AG Kurbrunnenweg 9, 67480 Edenkoben Germany |
| Name of the manufacturer of the biological active substance | Not available |
| Name and address of the manufacturer(s) responsible for batch release | Not available |
| Max shelf life | 3 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Sodium Chloride Calcium Chloride Dihydrate Water for Injections |
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