ROFERON-A PFS 3 M IU/0.5 ml

Transcription

1 Safety Data Sheet ROFERON-A PFS 3 M IU/0.5 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 ROFERON-A PFS 3 M IU/0.5 ml SAP Relevant identified uses of the substance or mixture and uses advised against Use - pharmaceutical active substance * Details of the supplier of the safety data sheet Company information Enquiries: F. Hoffmann-La Roche AG Postfach CH-4070 Basel Switzerland Local representation: Phone / Fax / info.sds@roche.com 1.4. Emergency telephone number Emergency telephone number Phone / 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 Synonyms with other inactive ingredients - ROFERON-A Prefilled Syringes 3 M IU/0.5 ml Page: 1/7

2 Ingredient Concentration GHS-Classification (pure ingredient) Sodium chloride Ammonium acetate Benzyl alcohol Polysorbate I.U./ml 7.21 mg/ml 0.77 mg/ml 10.0 mg/ml - Acute toxicity (Category 4), H312 - Acute toxicity (Category 4), H332 - Acute toxicity (Category 4), H mg/ml water solution suitable for injection > 98 % For the full text of the Hazard statements mentioned in this Section, see Section 16. SECTION 4: First aid measures 4.1. Description of first aid measures Eye contact Skin contact Inhalation - rinse immediately with tap water for at least 20 minutes - open eyelids forcibly - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents - remove the casualty to fresh air and keep him/her calm - 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 Page: 2/7

3 5.2. Special hazards arising from the substance or mixture Specific hazards - no particular hazards known 5.3. Advice for firefighters Protection of fire-fighters - 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 7.2. Conditions for safe storage, including any incompatibilities Storage conditions C - do not freeze Validity Packaging materials - 24 months, 2 to 8 C, after opening the content should be used within a short period, see expiry date on the label - keep it in the outer carton in order to protect from light - prefilled syringes SECTION 8: Exposure controls/personal protection 8.1. Control parameters Threshold value (Roche) air - IOEL (Internal Occupational Exposure Limit): 0.02 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 colourless sterile liquid ph value 4.8 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 - light - warming Incompatible materials Hazardous decomposition products Page: 4/7

5 SECTION 11: Toxicological information Information on toxicological effects Acute toxicity - LD I.U./kg (i.v., several species) *1 - LD I.U./kg (i.m., several species) *1 - LD I.U./kg (oral, several species) *1 Local effects - eye: non-irritant (rabbit) *1 - skin: slightly irritant (rabbit) *1 Sensitization Mutagenicity - not mutagenic (various in vivo and in vitro test systems) *1 Carcinogenicity - no information available Reproductive toxicity - not teratogenic *1 STOT-single exposure STOT-repeated exposure Aspiration hazard - Interferons are produced by cells as a reaction to viral infections. They are active against viruses, inhibit the growth of certain cells and influence the immune systeme, sometimes inhibiting it, sometimes stimulating it. *1 - elimination half life: 5 hours; inactivation through renal filtration and reabsorption processes *1 - at therapeutic doses, interferon alfa-2a commonly causes influenzalike symptoms such as fever, headache, myalgia etc. *1 - pre-existing auto-immune diseases may be influenced in an inpredictable manner, either positively or negatively *1 - about one fourth of those treated develop antibodies against interferon alfa-2a, however, these antibodies do not cause any symptoms *1 SECTION 12: Ecological information Toxicity Ecotoxicity - barely toxic for planktonic crustaceans (Daphnia magna) EC 50 (48 h) > 100 mg/l (nominal concentration) NOEC (48 h) 100 mg/l (nominal concentration) (OECD No. 202) *1 Page: 5/7

6 - barely toxic for algae (Desmodesmus (=Scenedesmus) subspicatus) ErC 50 (72 h) > 100 mg/l (nominal concentration) EbC 50 (72 h) < 100 mg/l (nominal concentration) NOEC (72 h) < 100 mg/l (nominal concentration) (OECD No. 201) * Persistence and degradability Ready biodegradability - proteins are generally well biodegradable *1 - readily biodegradable 100 % 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 *1 *2 referring to: referring to: Solution SECTION 13: Disposal considerations Waste treatment methods Waste from residues - observe local/national regulations regarding waste disposal SECTION 14: Transport information - not classified as Dangerous Good according to the Dangerous Goods Regulations Page: 6/7

7 SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture Water hazard class (Germany) 1: weakly hazardous for water (according to directive AwSV of ) SECTION 16: Other information Full text of H-Statements referred to under section 3 H302 Harmful if swallowed. H312 Harmful in contact with skin. H332 Harmful if inhaled. - 1 mg protein is equivalent to 270 m.i.u. *1 - 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 3, 15 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