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Dornase alfa Safety Data Sheet according to Regulation (EC) No 1907/2006 1. Identification of the substance/preparation and of the company/undertaking Product name Dornase alfa Product code CSE-1040 Use - pharmaceutical active substance - hydrolyzes the DNA present in sputum/mucus of cystic fibrosis patients and reduces viscosity in the lungs, promoting improved clearance of secretions Enquiries: F. Hoffmann-La Roche AG Postfach CH-4070 Basel Switzerland Phone +41-61/688 54 80 Fax +41-61/681 72 76 E-Mail info.sds@roche.com Local representation: Company information 2. Hazards identification Most important hazards - No particular hazards known. 3. Composition/Information on ingredients Characterization recombinant human glycoprotein Synonyms - Deoxyribonuclease - DNase - EC 3.1.21.1 - Pulmozyme *1 CAS number 143831-71-4 Molecular mass ~ 37000 g/mol *1 Pulmozyme solution for inhalation referring to: Page: 1/4 Replacing edition of: 20.3.07 Date: 2.8.08/CSE (SEISMO) Dornase alfa 4. First-aid measures Eye contact - rinse immediately with tap water for 10 minutes - open eyelids forcibly Skin contact - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents Inhalation - remove the casualty to fresh air and keep him/her calm - in the event of symptoms get medical treatment Note to physician - treat symptomatically 5. Fire-fighting measures Suitable extinguishing media - adapt extinguishing media to surrounding fire conditions Protection of fire-fighters - precipitate gases/vapours/mists with water spray 6. Accidental release measures Methods for cleaning up - collect solids (avoid dust formation) and hand over to waste removal 7. Handling and storage Handling Suitable materials - aluminium, glass, enamel, stainless steel, food-approved plastics Storage Storage conditions - 2 - 8 °C *1 - protected from light *1 Validity - see expiry date on the label *1 *1 Pulmozyme solution for inhalation referring to: 8. Exposure controls/Personal protection Engineering Measures - see 7. Personal protective equipment Hand protection - protective gloves (eg made of neoprene, nitrile or butyl rubber) Eye protection - safety glasses Page: 2/4 Replacing edition of: 20.3.07 Date: 2.8.08/CSE (SEISMO) Dornase alfa 9. Physical and chemical properties Form freeze-dried powder aqueous solution *1 Melting temperature 67 °C *1 Pulmozyme solution for inhalation referring to: 10. Stability and reactivity Stability - stable under the conditions mentioned in chapter 7 Conditions to avoid - temperatures above 30 °C Note - the solution must be clear and colourless, otherwise it must be disposed of *1 *1 Pulmozyme solution for inhalation referring to: 11. Toxicological information Acute toxicity not bioavailable by oral administration - Sensitization - asymptomatic sensitization via inhalation has been reported Mutagenicity not mutagenic (various in vivo and in vitro test systems) - Carcinogenicity no indication for carcinogenicity - Reproduction toxicity - not teratogenic, not embryotoxic (several species) Note - dosage (inhalation): 2.5 mg/d 12. Ecological information Ready biodegradability - globular proteins are generally well biodegradable Air pollution - observe local/national regulations 13. Disposal considerations Waste from residues - observe local/national regulations regarding waste disposal 14. Transport information Note - not classified by transport regulations Page: 3/4 Replacing edition of: 20.3.07 Date: 2.8.08/CSE (SEISMO) Dornase alfa 15. Regulatory information Note - no classification and labelling according to EU directives Water hazard class (Germany) 1: weakly hazardous for water (own classification according to directive VwVwS of 17.05.1999) 16. Other information NFPA Rating - Health: 0 Fire: 1 Reactivity: 0 Edition documentation - changes from previous version in sections 1, 2, 3, 16 The information in this safety data sheet is based on current scientific knowledge. It should not be taken as expressing or implying any warranty concerning product characteristics. Page: 4/4 Replacing edition of: 20.3.07 Date: 2.8.08/CSE (SEISMO)
