General Information
Revision date
2013-02-27
Product name
KADCYLATM Lyophilized Powder in Vials (100 & 160 mg)
Product Synonyms
- T-DM1 with excipients lyophilized
1.2.1 Relevant identified uses
- formulated pharmaceutical active substance (antineoplastic)
Emergency telephone
US emergency phone: (800)-827-6243
Icons in SDS
Company Information
company name
Hoffmann-La Roche Inc
e-mail address of the competent person responsible for the Safety Data Sheet
info.sds@roche.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H301, H312, H340, H350, H360FD
Hazard statements
Code
Statements
H301
Toxic if swallowed
Section 2
SECTION 2: Hazards identification
GHS Classification Emergency Overview Form lyophilized powder Color white 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. - Carcinogenicity: not listed by NTP, IARC or OSHA
Health hazards
3.1 dermal Acute toxicity (Category 4) H312 Harmful in contact with skin. 3.1 oral Acute toxicity (Category 3) H301 Toxic if swallowed. 3.5 Germ cell mutagenicity (Category 1B) H340 May cause genetic defects. 3.6 Carcinogenicity (Category 1B) H350 May cause cancer. 3.7 FD Reproductive toxicity (Category 1B) H360FD May damage fertility. May damage the unborn child.
Signal word
Danger Label:
Precautionary statements
P201 Obtain special instructions before use. - P280 Wear protective gloves/ protective clothing / eye protection / face protection. - P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. - P302 + P352 IF ON SKIN: Wash with plenty of soap and water. - P309 + P310 IF exposed or if you feel unwell: Immediately call a POISON CENTER or doctor/physician.
2.3 Other hazards
Additional Health Information - Conditions Aggravated: Hypersensitivity to this material and other materials in its chemical class. mg) - 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.
