General Information
Version
4.12
Revision date
2024-09-03
Product name
DOXIL
Substance name
DOXIL 2 mg/ml concentrate for solution for infusion CAELYX Pegylated liposomal doxorubicin hydrochloride
1.2.1 Relevant identified uses
Finished Pharmaceutical Product
supplier name
Janssen Pharmaceutica NV
Emergency telephone
+3214602111, 1-800-424-9300, +1 703-741-5970
Icons in SDS
Company Information
company name
Janssen Pharmaceutica NV
e-mail address of the competent person responsible for the Safety Data Sheet
SDSJanssen@its.jnj.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H302, H315, H318, H335, H350, H361fd
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
SECTION 2: Hazards identification
Signal word
Danger
Hazard statements
H302 Harmful if swallowed. H315 Causes skin irritation. H318 Causes serious eye damage. H335 May cause respiratory irritation. H350 May cause cancer. H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.
Prevention
P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P261 Avoid breathing mist or vapours. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response
P301 + P312 + P330 IF SWALLOWED: Call a POISON CENTER/ doctor if you feel unwell. Rinse mouth. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P304 + P340 + P312 IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/ doctor if you feel unwell. P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor. P308 + P313 IF exposed or concerned: Get medical advice/ attention. P332 + P313 If skin irritation occurs: Get medical advice/ P362 Take off contaminated clothing and wash before reuse.
Storage
P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P405 Store locked up.
Disposal
P501 Dispose of contents/ container to an approved waste disposal plant.
Other hazards
Refer to the pharmacotherapeutic group (section 1.2) and the patient packaging insert to evaluate the possible workplace hazards when this Finished Pharmaceutical Product is accidently leaking, broken or crushed
2.1 Classification of the substance or mixture
1910.1200) Acute toxicity (Oral) : Category 4 Skin irritation : Category 2 Serious eye damage : Category 1 Carcinogenicity : Category 1B Reproductive toxicity : Category 2 Specific target organ toxicity : Category 3 (Respiratory system) - single exposure
