General Information
Product name
KADCYLATM Solution
Product Synonyms
- T-DM1 (RO5304020) 2% aqueous solution with excipients
1.2.1 Relevant identified uses
- formulated pharmaceutical active substance (antineoplastic)
Icons in SDS
Company Information
company name
Enquiries
e-mail address of the competent person responsible for the Safety Data Sheet
info.sds@roche.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H302
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
SECTION 2: Hazards identification
OSHA Emergency Overview Form liquid Color colorless Hazard Overview - May cause allergic reactions. - Harmful if swallowed. - May cause birth defects based on information on related materials
Potential health effects
- Exposure: Inhalation, Ingestion, Skin contact, Eye contact - Target Organs: liver, Cardiovascular system, gastrointestinal system, Hematopoietic/blood system, Immune System, respiratory system - Acute Effects: May cause allergic reactions., Harmful if swallowed., May cause headache., May cause musculoskeletal effects., May cause general body weakness, fatigue and nausea.
Potential chronic health
May cause hepatic (liver) system effects., Signs and symptoms may include elevation of liver enzyme levels and jaundice (yellowing of the skin and eyes)., May cause cardiovascular effects., Signs and symptoms may include increase or decrease in blood pressure, irregular heartbeat, chest pains and cardiac arrest., May cause blood system changes., May cause respiratory effects., Signs and symptoms may include difficulty in breathing, coughing, wheezing, irritation (inflammation) and respiratory arrest.
Health hazards
oral Acute toxicity (Category 4) H302 Harmful if swallowed Signalword: Warning Label
Precautionary statements
- P312 Call a POISON CENTER or doctor/physician if you feel unwell.
2.3 Other hazards
Additional Health Information - Conditions Aggravated: Hypersensitivity to this material and other materials in its chemical class. - Reproduction Toxicity: May cause birth defects. Since this material may affect the developing fetus, females planning to have a child and pregnant women should exercise caution regarding exposure. - It is also advisable for nursing mothers to exercise caution regarding exposure. Note - no further information available
2.1 Classification of the substance or mixture
GHS Classification Health Hazards: 3.1 oral Acute toxicity (Category 4) H302 Harmful if swallowed. Signalword: Warning Label
