Safety Data Sheet ROFERON-A PFS 3 M IU/0.5 ml 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-10131273 1.2. Relevant identified uses of the substance or mixture and uses advised against Use - pharmaceutical active substance *1 1.3. Details of the supplier of the safety data sheet Company information Enquiries: Roche Products Pty Limited Level 8, 30-34 Hickson Road Millers Point NSW 2000 Australia Local representation: Phone 0061-2-9454-9624 Fax 0061-2-9971-7401 E-Mail info.sds@roche.com 1.4. Emergency telephone number Emergency telephone number Phone 0061-2-9454-9624 *1 SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification no classification and labelling according to GHS Australian Remark - Poisons Schedule - Schedule 4 *1 - Not listed on the Australian Inventory of Chemical Substances (AICS) *1 - Listed on the Australian Inventory of Chemical Substances (AICS) *2 - Listed on the Australian Inventory of Chemical Substances (AICS) *3 - Listed on the Australian Inventory of Chemical Substances (AICS) *4 - Listed on the Australian Inventory of Chemical Substances (AICS) *5 Page: 1/7
ROFERON-A PFS 3 M IU/0.5 ml 2.3. Other hazards *1 *2 *3 *4 *5 Sodium chloride Ammonium acetate Benzyl alcohol Polysorbate 80 SECTION 3: Composition/information on ingredients Characterization Synonyms with other inactive ingredients - ROFERON-A Prefilled Syringes 3 M IU/0.5 ml Ingredient Concentration GHS-Classification (pure ingredient) 76543-88-9 Sodium chloride 7647-14-5 Ammonium acetate 631-61-8 Benzyl alcohol 100-51-6 Polysorbate 80 9005-65-6 6000000 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), H302 0.2 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 Page: 2/7
ROFERON-A PFS 3 M IU/0.5 ml 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 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 - 2-8 C - do not freeze Page: 3/7
ROFERON-A PFS 3 M IU/0.5 ml 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 *1 8.2. Exposure controls Respiratory protection Hand protection Eye protection - respiratory protection not necessary during normal operations - protective gloves (eg made of neoprene, nitrile or butyl rubber) - safety glasses *1 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 5.2 9.2. Other information SECTION 10: Stability and reactivity 10.1. Reactivity 10.2. Chemical stability Stability - does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution Page: 4/7
ROFERON-A PFS 3 M IU/0.5 ml 10.3. Possibility of hazardous reactions 10.4. Conditions to avoid Conditions to avoid - light - warming 10.5. Incompatible materials 10.6. Hazardous decomposition products SECTION 11: Toxicological information 11.1. Information on toxicological effects Acute toxicity - LD 0 250 000 000 I.U./kg (i.v., several species) *1 - LD 0 500 000 000 I.U./kg (i.m., several species) *1 - LD 0 800 000 000 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 Page: 5/7
ROFERON-A PFS 3 M IU/0.5 ml - about one fourth of those treated develop antibodies against interferon alfa-2a, however, these antibodies do not cause any symptoms *1 *1 SECTION 12: Ecological information 12.1. 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 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 12.2. 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) *6 12.3. Bioaccumulative potential 12.4. Mobility in soil 12.5. Results of PBT and vpvb assessment 12.6. Other adverse effects *1 *6 Solution Page: 6/7
ROFERON-A PFS 3 M IU/0.5 ml SECTION 13: Disposal considerations 13.1. Waste treatment methods Waste from residues - observe local/national regulations regarding waste disposal SECTION 14: Transport information Australian Remark - ADG Code: This product is not classified as a dangerous good. No special transport conditions are necessary unless required by other regulations. SECTION 15: Regulatory information 15.1. 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 18.04.2017) 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 *1 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
Safety Data Sheet ROFERON-A PFS 4.5 M IU/0.5 ml SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code ROFERON-A PFS 4.5 M IU/0.5 ml SAP-10131929 1.2. Relevant identified uses of the substance or mixture and uses advised against Use - pharmaceutical active substance *1 1.3. Details of the supplier of the safety data sheet Company information Enquiries: Roche Products Pty Limited Level 8, 30-34 Hickson Road Millers Point NSW 2000 Australia Local representation: Phone 0061-2-9454-9624 Fax 0061-2-9971-7401 E-Mail info.sds@roche.com 1.4. Emergency telephone number Emergency telephone number Phone 0061-2-9454-9624 *1 SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification no classification and labelling according to GHS Australian Remark - Poisons Schedule - Schedule 4 *1 - Not listed on the Australian Inventory of Chemical Substances (AICS) *1 - Listed on the Australian Inventory of Chemical Substances (AICS) *2 - Listed on the Australian Inventory of Chemical Substances (AICS) *3 - Listed on the Australian Inventory of Chemical Substances (AICS) *4 - Listed on the Australian Inventory of Chemical Substances (AICS) *5 Page: 1/7
ROFERON-A PFS 4.5 M IU/0.5 ml 2.3. Other hazards *1 *2 *3 *4 *5 Sodium chloride Ammonium acetate Benzyl alcohol Polysorbate 80 SECTION 3: Composition/information on ingredients Characterization Synonyms with other inactive ingredients - ROFERON-A Prefilled Syringes 4.5 M IU/0.5 ml Ingredient Concentration GHS-Classification (pure ingredient) 76543-88-9 Sodium chloride 7647-14-5 Ammonium acetate 631-61-8 Benzyl alcohol 100-51-6 Polysorbate 80 9005-65-6 9000000 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), H302 0.2 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 Page: 2/7
ROFERON-A PFS 4.5 M IU/0.5 ml 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 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 - 2-8 C - do not freeze Page: 3/7
ROFERON-A PFS 4.5 M IU/0.5 ml 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 *1 8.2. Exposure controls Respiratory protection Hand protection Eye protection - respiratory protection not necessary during normal operations - protective gloves (eg made of neoprene, nitrile or butyl rubber) - safety glasses *1 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 5.2 9.2. Other information SECTION 10: Stability and reactivity 10.1. Reactivity 10.2. Chemical stability Stability - does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution Page: 4/7
ROFERON-A PFS 4.5 M IU/0.5 ml 10.3. Possibility of hazardous reactions 10.4. Conditions to avoid Conditions to avoid - light - warming 10.5. Incompatible materials 10.6. Hazardous decomposition products SECTION 11: Toxicological information 11.1. Information on toxicological effects Acute toxicity - LD 0 250 000 000 I.U./kg (i.v., several species) *1 - LD 0 500 000 000 I.U./kg (i.m., several species) *1 - LD 0 800 000 000 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 Page: 5/7
ROFERON-A PFS 4.5 M IU/0.5 ml - about one fourth of those treated develop antibodies against interferon alfa-2a, however, these antibodies do not cause any symptoms *1 *1 SECTION 12: Ecological information 12.1. 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 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 12.2. 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) *6 12.3. Bioaccumulative potential 12.4. Mobility in soil 12.5. Results of PBT and vpvb assessment 12.6. Other adverse effects *1 *6 Solution Page: 6/7
ROFERON-A PFS 4.5 M IU/0.5 ml SECTION 13: Disposal considerations 13.1. Waste treatment methods Waste from residues - observe local/national regulations regarding waste disposal SECTION 14: Transport information Australian Remark - ADG Code: This product is not classified as a dangerous good. No special transport conditions are necessary unless required by other regulations. SECTION 15: Regulatory information 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture Water hazard class (Germany) 1: weakly hazardous for water (own classification according to directive VwVwS of 17.05.1999) 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 *1 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
Safety Data Sheet ROFERON-A PFS 6 M IU/0.5 ml SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code ROFERON-A PFS 6 M IU/0.5 ml SAP-10064139 1.2. Relevant identified uses of the substance or mixture and uses advised against Use - pharmaceutical active substance *1 1.3. Details of the supplier of the safety data sheet Company information Enquiries: Roche Products Pty Limited Level 8, 30-34 Hickson Road Millers Point NSW 2000 Australia Local representation: Phone 0061-2-9454-9624 Fax 0061-2-9971-7401 E-Mail info.sds@roche.com 1.4. Emergency telephone number Emergency telephone number Phone 0061-2-9454-9624 *1 SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification no classification and labelling according to GHS Australian Remark - Poisons Schedule - Schedule 4 *1 - Not listed on the Australian Inventory of Chemical Substances (AICS) *1 - Listed on the Australian Inventory of Chemical Substances (AICS) *2 - Listed on the Australian Inventory of Chemical Substances (AICS) *3 - Listed on the Australian Inventory of Chemical Substances (AICS) *4 - Listed on the Australian Inventory of Chemical Substances (AICS) *5 Page: 1/7
ROFERON-A PFS 6 M IU/0.5 ml 2.3. Other hazards *1 *2 *3 *4 *5 Sodium chloride Ammonium acetate Benzyl alcohol Polysorbate 80 SECTION 3: Composition/information on ingredients Characterization Synonyms with other inactive ingredients - ROFERON-A Prefilled Syringes 6 M IU/0.5 ml Ingredient Concentration GHS-Classification (pure ingredient) 76543-88-9 Sodium chloride 7647-14-5 Ammonium acetate 631-61-8 Benzyl alcohol 100-51-6 Polysorbate 80 9005-65-6 12000000 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), H302 0.2 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 Page: 2/7
ROFERON-A PFS 6 M IU/0.5 ml 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 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 - 2-8 C - do not freeze Page: 3/7
ROFERON-A PFS 6 M IU/0.5 ml 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 *1 8.2. Exposure controls Respiratory protection Hand protection Eye protection - respiratory protection not necessary during normal operations - protective gloves (eg made of neoprene, nitrile or butyl rubber) - safety glasses *1 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 5.2 9.2. Other information SECTION 10: Stability and reactivity 10.1. Reactivity 10.2. Chemical stability Stability - does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution Page: 4/7
ROFERON-A PFS 6 M IU/0.5 ml 10.3. Possibility of hazardous reactions 10.4. Conditions to avoid Conditions to avoid - light - warming 10.5. Incompatible materials 10.6. Hazardous decomposition products SECTION 11: Toxicological information 11.1. Information on toxicological effects Acute toxicity - LD 0 250 000 000 I.U./kg (i.v., several species) *1 - LD 0 500 000 000 I.U./kg (i.m., several species) *1 - LD 0 800 000 000 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 Page: 5/7
ROFERON-A PFS 6 M IU/0.5 ml - about one fourth of those treated develop antibodies against interferon alfa-2a, however, these antibodies do not cause any symptoms *1 *1 SECTION 12: Ecological information 12.1. 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 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 12.2. 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) *6 12.3. Bioaccumulative potential 12.4. Mobility in soil 12.5. Results of PBT and vpvb assessment 12.6. Other adverse effects *1 *6 Solution Page: 6/7
ROFERON-A PFS 6 M IU/0.5 ml SECTION 13: Disposal considerations 13.1. Waste treatment methods Waste from residues - observe local/national regulations regarding waste disposal SECTION 14: Transport information Australian Remark - ADG Code: This product is not classified as a dangerous good. No special transport conditions are necessary unless required by other regulations. SECTION 15: Regulatory information 15.1. 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 18.04.2017) 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 *1 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
Safety Data Sheet ROFERON-A PFS 9 M IU/0.5 ml SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code ROFERON-A PFS 9 M IU/0.5 ml SAP-10064172 1.2. Relevant identified uses of the substance or mixture and uses advised against Use - pharmaceutical active substance *1 1.3. Details of the supplier of the safety data sheet Company information Enquiries: Roche Products Pty Limited Level 8, 30-34 Hickson Road Millers Point NSW 2000 Australia Local representation: Phone 0061-2-9454-9624 Fax 0061-2-9971-7401 E-Mail info.sds@roche.com 1.4. Emergency telephone number Emergency telephone number Phone 0061-2-9454-9624 *1 SECTION 2: Hazards identification 2.1. / 2.2. Classification of the substance or mixture / Label elements GHS Classification no classification and labelling according to GHS Australian Remark - Poisons Schedule - Schedule 4 *1 - Not listed on the Australian Inventory of Chemical Substances (AICS) *1 - Listed on the Australian Inventory of Chemical Substances (AICS) *2 - Listed on the Australian Inventory of Chemical Substances (AICS) *3 - Listed on the Australian Inventory of Chemical Substances (AICS) *4 - Listed on the Australian Inventory of Chemical Substances (AICS) *5 Page: 1/7
ROFERON-A PFS 9 M IU/0.5 ml 2.3. Other hazards *1 *2 *3 *4 *5 Sodium chloride Ammonium acetate Benzyl alcohol Polysorbate 80 SECTION 3: Composition/information on ingredients Characterization Synonyms with other inactive ingredients - ROFERON-A Prefilled Syringes 9 M IU/0.5 ml Ingredient Concentration GHS-Classification (pure ingredient) 76543-88-9 Sodium chloride 7647-14-5 Ammonium acetate 631-61-8 Benzyl alcohol 100-51-6 Polysorbate 80 9005-65-6 18000000 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), H302 0.2 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 Page: 2/7
ROFERON-A PFS 9 M IU/0.5 ml 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 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 - 2-8 C - do not freeze Page: 3/7
ROFERON-A PFS 9 M IU/0.5 ml 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 *1 8.2. Exposure controls Respiratory protection Hand protection Eye protection - respiratory protection not necessary during normal operations - protective gloves (eg made of neoprene, nitrile or butyl rubber) - safety glasses *1 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 5.2 9.2. Other information SECTION 10: Stability and reactivity 10.1. Reactivity 10.2. Chemical stability Stability - does not contain any antimicrobial preservative; therefore, care must be taken to ensure the sterility of the prepared solution Page: 4/7
ROFERON-A PFS 9 M IU/0.5 ml 10.3. Possibility of hazardous reactions 10.4. Conditions to avoid Conditions to avoid - light - warming 10.5. Incompatible materials 10.6. Hazardous decomposition products SECTION 11: Toxicological information 11.1. Information on toxicological effects Acute toxicity - LD 0 250 000 000 I.U./kg (i.v., several species) *1 - LD 0 500 000 000 I.U./kg (i.m., several species) *1 - LD 0 800 000 000 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 Page: 5/7
ROFERON-A PFS 9 M IU/0.5 ml - about one fourth of those treated develop antibodies against interferon alfa-2a, however, these antibodies do not cause any symptoms *1 *1 SECTION 12: Ecological information 12.1. 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 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 12.2. 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) *6 12.3. Bioaccumulative potential 12.4. Mobility in soil 12.5. Results of PBT and vpvb assessment 12.6. Other adverse effects *1 *6 Solution Page: 6/7
ROFERON-A PFS 9 M IU/0.5 ml SECTION 13: Disposal considerations 13.1. Waste treatment methods Waste from residues - observe local/national regulations regarding waste disposal SECTION 14: Transport information Australian Remark - ADG Code: This product is not classified as a dangerous good. No special transport conditions are necessary unless required by other regulations. SECTION 15: Regulatory information 15.1. 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 18.04.2017) 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 *1 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