ROFERON-A PFS 3 M IU/0.5 ml Safety Data Sheet SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name ROFERON-A PFS 3 M IU/0.5 ml Product code SAP-10131273 1.2. Relevant identified uses of the substance or mixture and uses advised against Use - pharmaceutical active substance *1 *1 1.3. Details of the supplier of the safety data sheet Enquiries: Roche Products Pty Limited Level 8, 30-34 Hickson Road Millers Point NSW 2000 Australia Phone 0061-2-9454-9624 Fax 0061-2-9971-7401 E-Mail [email protected]Local representation: Company information 1.4. Emergency telephone number Phone 0061-2-9454-9624 Emergency telephone number *1 Interferon alfa-2a referring to: 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 Replacing edition of: 17.7.15 Date: 3.11.17/LS (SEISMO)
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Safety Data Sheet ROFERON-A PFS 3 M IU/0.5 ml · Safety Data Sheet ROFERON-A PFS 3 M IU/0.5 ml ... Product code SAP-10131273 1.2. ... headache, myalgia etc. *1
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ROFERON-A PFS 3 M IU/0.5 mlSafety Data Sheet
SECTION 1: Identification of the substance/mixture and of thecompany/undertaking
1.1. Product identifier
Product name ROFERON-A PFS 3 M IU/0.5 ml
Product code SAP-10131273
1.2. Relevant identified uses of the substance or mixture and uses advised against
Use - pharmaceutical active substance *1*1
1.3. Details of the supplier of the safety data sheet
Acute toxicity LD0 250’000’000 I.U./kg (i.v., several species) *1-LD0 500’000’000 I.U./kg (i.m., several species) *1-LD0 800’000’000 I.U./kg (oral, several species) *1-
Local effects - eye: non-irritant (rabbit) *1
- skin: slightly irritant (rabbit) *1
Sensitization - no information available
Mutagenicity not mutagenic (various in vivo and in vitro test systems) *1-
Carcinogenicity no information available-
Reproductive toxicity - not teratogenic *1
STOT-single exposure - no information available
STOT-repeated exposure - no information available
Aspiration hazard - no information available
Note - Interferons are produced by cells as a reaction to viral infections.They are active against viruses, inhibit the growth of certain cellsand influence the immune systeme, sometimes inhibiting it,sometimes stimulating it. *1
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 byother 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 of18.04.2017)
SECTION 16: Other information
Full text of H-Statements referred to under section 3H302 Harmful if swallowed.H312 Harmful in contact with skin.H332 Harmful if inhaled.
Note - 1 mg protein is equivalent to 270 m.I.U. *1
- Please note this Safety Data Sheet for the bulk product does notapply for the finished, packaged medicinal product intended forthe final user.
Edition documentation - changes from previous version in sections 3, 15
*1 Interferon alfa-2areferring to:
The information in this safety data sheet is based on current scientific knowledge. It should not betaken as expressing or implying any warranty concerning product characteristics.
Acute toxicity LD0 250’000’000 I.U./kg (i.v., several species) *1-LD0 500’000’000 I.U./kg (i.m., several species) *1-LD0 800’000’000 I.U./kg (oral, several species) *1-
Local effects - eye: non-irritant (rabbit) *1
- skin: slightly irritant (rabbit) *1
Sensitization - no information available
Mutagenicity not mutagenic (various in vivo and in vitro test systems) *1-
Carcinogenicity no information available-
Reproductive toxicity - not teratogenic *1
STOT-single exposure - no information available
STOT-repeated exposure - no information available
Aspiration hazard - no information available
Note - Interferons are produced by cells as a reaction to viral infections.They are active against viruses, inhibit the growth of certain cellsand influence the immune systeme, sometimes inhibiting it,sometimes stimulating it. *1
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 byother 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 todirective VwVwS of 17.05.1999)
SECTION 16: Other information
Full text of H-Statements referred to under section 3H302 Harmful if swallowed.H312 Harmful in contact with skin.H332 Harmful if inhaled.
Note - 1 mg protein is equivalent to 270 m.I.U. *1
- Please note this Safety Data Sheet for the bulk product does notapply for the finished, packaged medicinal product intended forthe final user.
Edition documentation - changes from previous version in sections 3, 15
*1 Interferon alfa-2areferring to:
The information in this safety data sheet is based on current scientific knowledge. It should not betaken as expressing or implying any warranty concerning product characteristics.
Acute toxicity LD0 250’000’000 I.U./kg (i.v., several species) *1-LD0 500’000’000 I.U./kg (i.m., several species) *1-LD0 800’000’000 I.U./kg (oral, several species) *1-
Local effects - eye: non-irritant (rabbit) *1
- skin: slightly irritant (rabbit) *1
Sensitization - no information available
Mutagenicity not mutagenic (various in vivo and in vitro test systems) *1-
Carcinogenicity no information available-
Reproductive toxicity - not teratogenic *1
STOT-single exposure - no information available
STOT-repeated exposure - no information available
Aspiration hazard - no information available
Note - Interferons are produced by cells as a reaction to viral infections.They are active against viruses, inhibit the growth of certain cellsand influence the immune systeme, sometimes inhibiting it,sometimes stimulating it. *1
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 byother 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 of18.04.2017)
SECTION 16: Other information
Full text of H-Statements referred to under section 3H302 Harmful if swallowed.H312 Harmful in contact with skin.H332 Harmful if inhaled.
Note - 1 mg protein is equivalent to 270 m.I.U. *1
- Please note this Safety Data Sheet for the bulk product does notapply for the finished, packaged medicinal product intended forthe final user.
Edition documentation - changes from previous version in sections 3, 15
*1 Interferon alfa-2areferring to:
The information in this safety data sheet is based on current scientific knowledge. It should not betaken as expressing or implying any warranty concerning product characteristics.
Acute toxicity LD0 250’000’000 I.U./kg (i.v., several species) *1-LD0 500’000’000 I.U./kg (i.m., several species) *1-LD0 800’000’000 I.U./kg (oral, several species) *1-
Local effects - eye: non-irritant (rabbit) *1
- skin: slightly irritant (rabbit) *1
Sensitization - no information available
Mutagenicity not mutagenic (various in vivo and in vitro test systems) *1-
Carcinogenicity no information available-
Reproductive toxicity - not teratogenic *1
STOT-single exposure - no information available
STOT-repeated exposure - no information available
Aspiration hazard - no information available
Note - Interferons are produced by cells as a reaction to viral infections.They are active against viruses, inhibit the growth of certain cellsand influence the immune systeme, sometimes inhibiting it,sometimes stimulating it. *1
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 byother 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 of18.04.2017)
SECTION 16: Other information
Full text of H-Statements referred to under section 3H302 Harmful if swallowed.H312 Harmful in contact with skin.H332 Harmful if inhaled.
Note - 1 mg protein is equivalent to 270 m.I.U. *1
- Please note this Safety Data Sheet for the bulk product does notapply for the finished, packaged medicinal product intended forthe final user.
Edition documentation - changes from previous version in sections 3, 15
*1 Interferon alfa-2areferring to:
The information in this safety data sheet is based on current scientific knowledge. It should not betaken as expressing or implying any warranty concerning product characteristics.