Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
Pulmozyme 2500 U/2.5 ml, nebuliser solution.
| Pharmaceutical Form |
|---|
|
Nebuliser solution. Clear, colourless to slightly yellowish solution. |
Each ampoule contains 2500 U (corresponding to 2.5 mg) of dornase alfa* per 2.5 ml corresponding to 1000 U/ml or 1 mg/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
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dornase alfa |
Recombinant human DNase is a genetically engineered version of a naturally occurring human enzyme which cleaves extracellular DNA. In vitro, dornase alfa hydrolyses DNA in sputum and greatly reduces the viscoelasticity of cystic fibrosis sputum. |
| List of Excipients |
|---|
|
Sodium chloride |
2.5 ml of nebuliser solution in an ampoule (low density polyethylene plastic).
Pack sizes of 6 and 30.
Not all pack sizes may be marketed.
Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
PL 00031/0335
Date of first authorisation: 12 January 1994
Date of latest renewal: 11 March 2009
| Drug | Countries | |
|---|---|---|
| PULMOZYME | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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