VALCYTE(R) F.C. Tablets (450 mg)

Transcription

1 Material Safety Data Sheet VALCYTE(R) F.C. Tablets (450 mg) 1. Product and Company Identification Product name Product code Use Company information VALCYTE(R) F.C. Tablets (450 mg) CSE2028 VALCYTE(R) is an antiviral indicated for the treatment of Cytomegalovirus Retinitis and Cytomegalovirus Disease. Enquiries: HoffmannLa Roche Inc. 340 Kingsland Street USANutley, N.J United States of America Local representation: Phone / US Emergency phone: (800) US Chemtrec phone: (800) Hazards identification Emergency Overview Form Color Hazard Overview Potential Health Effects tablets pink May cause blood system changes. May cause birth defects based on information on related materials May cause reproductive systems effects based on information on related materials Possible dust explosion hazard based on information on related materials May cause cancer based on information on related materials. Exposure: Inhalation, Ingestion, Skin contact, Eye contact Target Organs: eye, Hematopoietic/blood system, Male reproductive system, Female reproductive system Acute Effects: May cause eye irritation., This material has not been tested as a whole; therefore, the information described below is based on one or more of its ingredients. Chronic Effects: May cause blood system effects. Carcinogenicity: formulation not listed by NTP, IARC or OSHA Replacing edition of: Page: 1/6

2 VALCYTE(R) F.C. Tablets (450 mg) Additional Health Information Carcinogenicity: May cause cancer based on information on related materials. Reproductive Toxicity: May cause birth defects based on information on related materials. Since this material may affect reproductive capabilities and the developing fetus, females and males planning to have a child and pregnant women should exercise caution regarding potential exposure. It is also advisable for nursing mothers to exercise caution regarding exposure. 3. Composition/Information on ingredients Characterization final product Ingredients Valganciclovir hydrochloride (milled) CAS: Microcrystalline cellulose CAS: Concentration ~ 83 % ~ 8 % 4. Firstaid measures Eye contact Skin contact Inhalation Ingestion in case of contact with eyes rinse thoroughly with plenty of water and get medical advice remove immediately contaminated clothes, wash affected skin with plenty of water in case of inhalation remove to fresh air and seek medical aid consult physician 5. Firefighting measures Suitable extinguishing media Flash point (liquid) Specific hazards Protection of firefighters Special method of firefighting water spray jet, dry powder, foam, carbon dioxide not applicable Toxic emissions may be given off in a fire use selfcontained breathing apparatus cool endangered containers with water spray Replacing edition of: Page: 2/6

3 VALCYTE(R) F.C. Tablets (450 mg) 6. Accidental release measures Personal precautions Environmental protection Methods for cleaning up ensure adequate ventilation avoid release to the environment Scoop or shovel spilled material into a suitable labeled open head drum Secure the drum cover and move the container to a safe holding area Clean spill area thoroughly Collect wash with a noncombustible absorbent material and transfer to labeled container for treatment and disposal. Check area for residual material and repeat clean up if detected 7. Handling and storage Handling Technical measures local exhaust ventilation necessary avoid dust formation; consider dust explosion hazard Storage Storage conditions keep containers tightly closed room temperature store in a dry place 8. Exposure controls/personal protection Engineering Measures see 7. Threshold value (USA) air ACGIHTLV: 10 mg/m3 *1 OSHAPEL: 5 mg/m3 (respirable dust fraction) *1 OSHAPEL: 15 mg/m3 (total dust) *1 NIOSHREL: 5 mg/m3 (respirable dust fraction) *1 NIOSHREL: 10 mg/m3 (total dust) *1 Threshold value (Roche) air IOEL (Internal Occupational Exposure Limit): 5 µg/m3 *2 Personal protective equipment Respiratory protection Hand protection Eye protection Respiratory protection is recommended as a precaution to minimze exposure. Effective engineering controls are considered to be the primary means to control worker exposure. Respiratory protection should not substitute for feasible engineering controls. in case of open handling of larger quantities or accidental release: particle mask or respirator with independent air supply protective gloves safety glasses Replacing edition of: Page: 3/6

4 VALCYTE(R) F.C. Tablets (450 mg) Body protection protective clothing *1 *2 Microcrystalline cellulose Valganciclovir hydrochloride (milled) 9. Physical and chemical properties Color Form Solubility pink tablets soluble, water 10. Stability and reactivity Stability stable under the conditions mentioned in chapter 7 Conditions to avoid Materials to avoid Note high temperatures strong acids, oxidizing agents Hazardous polymerization: Will not occur 11. Toxicological information Acute toxicity LD 50 > mg/kg (oral, mouse) *2 LD 50 > mg/kg (oral, dog) *2 Local effects eye: nonirritant (rabbit) *2 skin: nonirritant (rabbit) *2 Sensitization nonsensitizing (guinea pig) *2 Chronic toxicity NOEL 2 mg/kg/d (oral, rat; 90 days) *2 NOAEL 1 mg/kg/d (oral, mouse; 180 days) *2 NOEL < 0.2 mg/kg/d (oral, dog; 90 days) *2 Mutagenicity mutagenic *2 Carcinogenicity carcinogenic *3 Note excretion is mainly renal *2 elimination halflife: 5 h *2 after oral administration ester hydrolysis to the active substance Ganciclovir *2 occurs testicular atrophy, renal and hematologic changes *2 *2 *3 Valganciclovir hydrochloride (milled) Ganciclovir Replacing edition of: Page: 4/6

5 VALCYTE(R) F.C. Tablets (450 mg) 12. Ecological information Inherent biodegradability Ecotoxicity Mobility not inherently biodegradable 2 %, 28 days *3 evidence for mediumterm biodegradation in surface waters *3 evidence for mediumterm biodegradation in surface waters 34 %, 28 d (analogous to OECD 308, Transformation in natural water/sediment systems) *3 inherently biodegradable *1 barely toxic for microorganisms (bacteria, fungi, cyanobacteria in pure culture) NOEC 1000 mg/l *3 barely toxic for planktonic crustaceans (Daphnia magna) EC 50 (48 h) > 1010 mg/l (average measured concentration) NOEC (48 h) 1010 mg/l (average measured concentration) *3 barely toxic for fish (rainbow trout) LC 50 (96 h) > 1020 mg/l (average measured concentration) NOEC (96 h) 1020 mg/l (average measured concentration) *3 barely toxic for fish (bluegill sunfish) LC 50 (96 h) > 1020 mg/l (average measured concentration) NOEC (96 h) 1020 mg/l (average measured concentration) *3 barely toxic for bluegreen algae (nominal concentration > 100 mg/l) (Nostoc sp.) NOEC (12 d) 1000 mg/l (FDA Technical Assistance Document No. 4.02) *3 barely volatile (waterair) KH = Pa*m3/mol (vapor pressure/water solubility) *3 *1 *3 Microcrystalline cellulose Ganciclovir 13. Disposal considerations Waste from residues Contaminated packaging RCRA waste incinerate in qualified installation with flue gas scrubbing observe local/national regulations regarding waste disposal DO NOT FLUSH unused medications or Pour them down a sink or drain. If available in your area, use takeback programs run by household hazardous waste collection programs or community pharmacies to dispose of unused and expired medicines. If you don t have access to a takeback program, dispose of these medicines in the household trash by removing them from their original containers and mixing them with an undesirable substance, such as used coffee grounds or kitty litter. Empty containers must be triple rinsed prior to disposal, recycling or reuse. not regulated under RCRA Replacing edition of: Page: 5/6

6 VALCYTE(R) F.C. Tablets (450 mg) 14. Transport information Note not classified by transport regulations, proper shipping name nonregulated 15. Regulatory information TSCA Status Reporting Requirements FDA Exemption not on inventory The United States Environmental Protection Agency (USEPA) has not established a Reportable Quantity (RQ) for releases of this material. In New Jersey, report all releases which enter a waterway or into soil, or which are likely to endanger the public health, harm the environment or cause a complaint to the NJDEPE Hotline ( ) and to local officials. State and local regulations vary and may impose additional reporting requirements. 16. Other information Edition documentation first edition 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. Replacing edition of: Page: 6/6

7 Material Safety Data Sheet VALCYTE(R) Powder for Constitution 1. Product and Company Identification Product name VALCYTE(R) Powder for Constitution Product code Use Company information Therapeutic Category: Antiviral Enquiries: HoffmannLa Roche Inc. 340 Kingsland Street USANutley, N.J United States of America Phone / US Emergency phone: (800) US Chemtrec phone: (800) Hazards identification Emergency Overview Form Color Hazard Overview Potential Health Effects powder white to slightly yellow May cause blood system changes. May cause birth defects based on information on related materials May cause reproductive systems effects based on information on related materials Possible dust explosion hazard based on information on related materials Exposure: Inhalation, Ingestion, Skin contact, Eye contact Target Organs: Hematopoietic/blood system Acute Effects: May cause eye irritation., This material has not been tested as a whole; therefore, the information described below is based on one or more of its ingredients. Chronic Effects: May cause blood system effects. Carcinogenicity: formulation not listed by NTP, IARC or OSHA Additional Health Information Reproduction Toxicity: May cause birth defects based on information on related materials. Since this material may affect reproductive capability and the developing fetus, females and males planning to have a child and pregnant women should exercise caution regarding exposure. Date: /CSE (SEISMO) Replacing edition of: Page: 1/5

8 VALCYTE(R) Powder for Constitution 3. Composition/Information on ingredients It is also advisable for nursing mothers to exercise caution regarding exposure. Ingredients Valganciclovir hydrochloride CAS: Fumaric acid CAS: Concentration ~ 46 % ~ 2 % 4. Firstaid measures Eye contact Skin contact Inhalation Ingestion in case of contact with eyes rinse thoroughly with plenty of water and get medical advice remove immediately contaminated clothes, wash affected skin with plenty of water in case of inhalation remove to fresh air and seek medical aid consult physician 5. Firefighting measures Suitable extinguishing media water spray jet, dry powder, foam, carbon dioxide Flash point (liquid) (Not applicable) Specific hazards Protection of firefighters Special method of firefighting consider dust explosion hazard use selfcontained breathing apparatus cool endangered containers with water spray 6. Accidental release measures Personal precautions ensure adequate ventilation Date: /CSE (SEISMO) Replacing edition of: Page: 2/5

9 VALCYTE(R) Powder for Constitution 7. Handling and storage Handling Technical measures Use with adequate ventilation processing in closed systems, if possible superposed by inert gas (e.g. nitrogen) avoid dust formation; consider dust explosion hazard take precautionary measures against electrostatic charging Storage Storage conditions 2 25 C dry and ventilated place 8. Exposure controls/personal protection Engineering Measures see 7. Threshold value (Roche) air IOEL (Internal Occupational Exposure Limit): 5 µg/m3 *1 Personal protective equipment Respiratory protection Hand protection Eye protection Body protection General protective and hygiene measures Respiratory protection is recommended as a precaution to minimze exposure. Effective engineering controls are considered to be the primary means to control worker exposure. Respiratory protection should not substitute for feasible engineering controls. Respiratory protection is recommended for dusty operations. Use of a negative pressure air purifying, half face respirator with a toxic/dust/mist/fume high efficiency filter in the laboratory or a suppliedair full facepiece respirator or suppliedair hood for production operations is recommended. protective gloves tightly fitting safety glasses protective clothing instruction of employees mandatory shower after work recommended *1 Valganciclovir hydrochloride 9. Physical and chemical properties Color Form white to slightly yellow powder Date: /CSE (SEISMO) Replacing edition of: Page: 3/5

10 VALCYTE(R) Powder for Constitution 10. Stability and reactivity Stability Materials to avoid stable under normal conditions strong oxidizing agents 11. Toxicological information Acute toxicity LD 50 > mg/kg (oral, mouse) *1 LD 50 > mg/kg (oral, dog) *1 Local effects eye: nonirritant (rabbit) *1 skin: nonirritant (rabbit) *1 skin: slightly irritating (rabbit) *2 eye: moderately irritating (rabbit) *2 Sensitization nonsensitizing (guinea pig) *1 Chronic toxicity NOEL 2 mg/kg/d (oral, rat; 90 days) *1 NOAEL 1 mg/kg/d (oral, mouse; 180 days) *1 NOEL < 0.2 mg/kg/d (oral, dog; 90 days) *1 Mutagenicity mutagenic *1 Note excretion is mainly renal *1 elimination halflife: 5 h *1 after oral administration ester hydrolysis to the active substance Ganciclovir *1 occurs testicular atrophy, renal and hematologic changes *1 *1 *2 Valganciclovir hydrochloride FUMARIC ACID 12. Ecological information Inherent biodegradability Ecotoxicity not inherently biodegradable 2 %, 28 days *3 evidence for mediumterm biodegradation in surface waters *3 barely toxic for microorganisms (bacteria, fungi, cyanobacteria in pure culture) NOEC 1000 mg/l *3 barely toxic for planktonic crustaceans (Daphnia magna) EC 50 (48 h) > 1010 mg/l (average measured concentration) NOEC (48 h) 1010 mg/l (average measured concentration) *3 barely toxic for fish (rainbow trout) LC 50 (96 h) > 1020 mg/l (average measured concentration) NOEC (96 h) 1020 mg/l (average measured concentration) *3 barely toxic for fish (bluegill sunfish) LC 50 (96 h) > 1020 mg/l (average measured concentration) NOEC (96 h) 1020 mg/l (average measured concentration) *3 Oncorhynchus kisutch LC 50 (24 weeks) 10 mg/l *2 Daphnia magna EC 50 (48 hours) 212 mg/l *2 Date: /CSE (SEISMO) Replacing edition of: Page: 4/5

11 VALCYTE(R) Powder for Constitution Mobility barely volatile (waterair) KH = Pa*m3/mol (vapor pressure/water solubility) *3 *2 *3 FUMARIC ACID Ganciclovir 13. Disposal considerations Waste from residues RCRA waste observe local/national regulations regarding waste disposal incinerate in qualified installation with flue gas scrubbing not regulated under RCRA 14. Transport information Note not classified by transport regulations, proper shipping name nonregulated 15. Regulatory information TSCA Status Reporting Requirements FDA Exemption not on inventory The United States Environmental Protection Agency (USEPA) has not established a Reportable Quantity (RQ) for releases of this material. In New Jersey, report all releases which are likely to endanger the public health, harm the environment or cause a complaint to the NJDEPE Hotline ( ) and to local officials. State and local regulations vary and may impose additional reporting requirements. 16. Other information Edition documentation changes from previous version in sections 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. Date: /CSE (SEISMO) Replacing edition of: Page: 5/5