Interferon alfa-2a Solution

Transcription

1 Safety Data Sheet Solution 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 Solution Product code Relevant identified uses of the substance or mixture and uses advised against Use - formulated pharmaceutical active substance 1.3. 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 naturally occurring protein with antiviral and immuno-modulatory properties *1 - Roferon-A Page: 1/7

2 Solution Ingredient Concentration GHS-Classification (pure ingredient) I.U./ml Sodium chloride Ammonium acetate Polysorbate Benzyl alcohol mg/ml - Acute toxicity (Category 4), H312 - Acute toxicity (Category 4), H332 - Acute toxicity (Category 4), H302 water solution suitable for injection For the full text of the H-phrases 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 10 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 - 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 Solution 5.2. Special hazards arising from the substance or mixture Specific hazards - formation of toxic and corrosive combustion gases (nitrogen oxides, sulfur oxides) possible SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures Personal precautions - ensure adequate ventilation 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 - clean floors and contaminated objects with plenty of 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 - protected from light Validity - 48 months, -80 C *1 - see "best use before" date stated on the label, in the unopened original container Packaging materials - 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 *1 Page: 3/7

4 Solution 8.2. Exposure controls General protective and hygiene measures Respiratory protection Hand protection Eye protection - instruction of employees recommended - respiratory protection not necessary during normal operations - breathing apparatus in case of aerosol mist formation - 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 Odour Solubility colourless to slightly yellow solution odourless completely soluble, water ph value 4.5 to Other information SECTION 10: Stability and reactivity Reactivity Chemical stability Stability - stable under the conditions mentioned in chapter Possibility of hazardous reactions Conditions to avoid Page: 4/7

5 Solution Incompatible materials Hazardous decomposition products 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 Mutagenicity - not mutagenic (various in vivo and in vitro test systems) *1 Reproductive toxicity - not teratogenic *1 - 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 - Dosage: as needed; doses range from 1.5 million I.U. 3 times weekly to 36 million I.U. daily, i.m. or s.c. *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 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) *1 Page: 5/7

6 Solution - 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) * 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 Air pollution - observe local/national regulations 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 Solution 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 Edition documentation - changes from previous version in sections 3, 8 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