MIRCERA PFS 120 mcg/0.3 ml

Transcription

1 Safety Data Sheet MIRCERA PFS 120 mcg/0.3 ml according to Regulation (EU) nr. 1907/2006 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code MIRCERA PFS 120 mcg/0.3 ml SAP Relevant identified uses of the substance or mixture and uses advised against Use intravenous (IV) or subcutaneous (SC) injection 1.3. Details of the supplier of the safety data sheet Company information Enquiries: F. HoffmannLa Roche AG Postfach CH4070 Basel Switzerland Local representation: Phone +4161/ Fax +4161/ Emergency telephone number Emergency telephone number Phone +4161/ SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification no classification and labelling according to CLP (EC Regulation 1272/2008) 2.3. Other hazards SECTION 3: Composition/information on ingredients Characterization monopegylated epoetinβ, consisting of recombinant human epoetinβ protein which is bound covalently to a linear methoxypolyethylene glycol, with maintenance of its own glycosylation *1 Page: 1/7

2 Synonyms MIRCERA Prefilled Syringes 120 mcg/0.3 ml Ingredient Concentration GHSClassification (pure ingredient) Mannitol LMethionine Sodium sulfate mg/ml 30 mg/ml 1.49 mg/ml 5.68 mg/ml water solution suitable for injection SECTION 4: First aid measures 4.1. Description of first aid measures Eye contact Skin contact Inhalation rinse with tap water for 10 minutes open eyelids forcibly drench affected skin with water in the event of symptoms get medical treatment 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed to physician treat symptomatically SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media adapt extinguishing media to surrounding fire conditions 5.2. Special hazards arising from the substance or mixture Specific hazards no particular hazards known Page: 2/7

3 5.3. Advice for firefighters Protection of firefighters precipitate gases/vapours/mists with water spray SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures Personal precautions no special precautions required 6.2. Environmental precautions Environmental protection no special environmental precautions required 6.3. Methods and material for containment and cleaning up Methods for cleaning up mop or flush the contaminated area with water SECTION 7: Handling and storage 7.1. Precautions for safe handling Suitable materials glass, tested plastics 7.2. Conditions for safe storage, including any incompatibilities Storage conditions 2 8 C do not freeze protected from light do not shake solution Validity Packaging materials 30 days, at room temperature 36 months, 2 to 8 C, in the unopened original container, see "best use before" date stated on the label prefilled syringes keep it in the outer carton in order to protect from light SECTION 8: Exposure controls/personal protection 8.1. Control parameters Threshold value (Roche) air IOEL (Internal Occupational Exposure Limit): 0.5 µg/m3 * Exposure controls Respiratory protection respiratory protection not necessary during normal operations Page: 3/7

4 Hand protection Eye protection protective gloves (eg made of neoprene, nitrile or butyl rubber) safety glasses SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Colour Form Density slightly yellowish clear liquid g/cm3 Solubility > mg/l, water *1 ph value 6.0 to Other information SECTION 10: Stability and reactivity Reactivity Chemical stability Stability does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution Possibility of hazardous reactions Conditions to avoid Conditions to avoid warming light temperatures below 0 C Incompatible materials Page: 4/7

5 10.6. Hazardous decomposition products SECTION 11: Toxicological information Information on toxicological effects Acute toxicity NOAEL 750 µg/kg (i.v., several species) *1 not bioavailable by oral administration *1 Sensitization anaphylactic reactions may occur following the intravenous application of proteins; rare cases of hypersensitivity have been described Carcinogenicity not carcinogenic *1 Reproductive toxicity no indication for teratogenicity *1 stimulates the formation of red blood cells *1 therapeutic dose: 30 to 400 µg/week *1 SECTION 12: Ecological information Toxicity Ecotoxicity barely toxic for algae (nominal concentration > 100 mg/l) (Scenedesmus (=Desmodesmus) subspicatus) NOEC (72 h) 200 mg active substance/l EC 50 (72 h) > 200 mg active substance/l (OECD No. 201) *2 barely toxic for planktonic crustaceans (nominal concentration > 100 mg/l) (Daphnia magna) NOEC (48 h) 200 mg active substance/l EC 50 (48 h) > 200 mg active substance/l (OECD No. 202) *2 barely toxic for fish (nominal concentration > 100 mg/l) (zebrafish) NOEC (96 h) 200 mg active substance/l LC 50 (96 h) > 200 mg active substance/l (OECD No. 203) *2 no adverse influence on substrate biodegradation (activated sludge) concentration (14 d) 100 mg/l (measured initial concentration) (Manometric Respirometry Test, OECD No. 301 F) *2 Page: 5/7

6 12.2. Persistence and degradability Ready biodegradability not readily biodegradable complete primary degradation of active substance evidenced by HPLC 57 % BOD/ThOD, 28 d (Manometric Respirometry Test, OECD No. 301 F) * Bioaccumulative potential Mobility in soil Results of PBT and vpvb assessment Other adverse effects *2 referring to: MIRCERA injection solution, formulated C.E.R.A. with excipients SECTION 13: Disposal considerations Waste treatment methods Waste from residues observe local/national regulations regarding waste disposal SECTION 14: Transport information not classified by transport regulations SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture Water hazard class (Germany) not hazardous for water (own classification according to directive VwVwS of ) Page: 6/7

7 SECTION 16: Other information Please note this Safety Data Sheet for the bulk product does not apply for the finished, packaged medicinal product intended for the final user. Edition documentation changes from previous version in sections 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: 7/7