Note: Ingredients listed on restricted chemical lists
EC/CAS
100-51-6
Name of the chemical
Benzyl Alcohol
Concentration
<5%
General Information
Version
4.4
Revision date
2025-04-29
Product name
Amiodarone Hydrochloride Injection
Product Synonyms
Hydrochloride Injection USP, 450 mg/9 mL (50 mg/mL); Amiodarone Hydrochloride Injection USP, 900 mg/18 mL (50 mg/mL)
1.2.1 Relevant identified uses
Pharmaceutical. Use only as directed The intent of this safety data sheet (SDS) is to provide safety information for occupational handling of this product. This information may not be relevant for medical use of this product. Patients/ consumers should consult the package insert/ product label/ physician/ pharmacist for information regarding the usage of this product. For information on the ingredients used in this product, refer to the appropriate SDS for each ingredient
Emergency telephone
+1-813-248-0585, 1-800-255-3924, +1 877-446-3679
Icons in SDS
Company Information
company name
Mylan Inc
e-mail address of the competent person responsible for the Safety Data Sheet
SDScontact@viatris.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H350, H361, H362, H372, H411
Hazard statements
Code
Statements
H350
May cause cancer
Section 2
SECTION 2: Hazards identification
Pharmaceutical Agent – Handling of this product in its final form presents minimal occupational exposure risk Patients/Consumers: Please refer to the product information insert or product label for appropriate consumer-specific information about this product when used according to the physician’s directions
2.1 Classification of the substance or mixture
Carcinogenicity, Category 1B Reproductive toxicity, Category 2 Effects on or via lactation, Yes Specific target organ toxicity (repeated exposure), Category 1 ( Thyroid, lung and liver ) Chronic aquatic toxicity, Category 2
Signal word
Danger
Hazard statements
H350 - May cause cancer H361 - Suspected of damaging fertility or the unborn child H362 - May cause harm to breast-fed children H372 - Causes damage to organs through prolonged or repeated exposure H411 - Toxic to aquatic life with long lasting effects
Prevention
Obtain special instructions before use Do not handle until all safety precautions have been read and understood Wear protective gloves/protective clothing/eye protection/face protection Avoid contact during pregnancy/while nursing Wash face, hands and any exposed skin thoroughly after handling Do not eat, drink or smoke when using this product Do not breathe dust/fume/gas/mist/vapors/spray Avoid release to the environment
Response
IF exposed or concerned: Get medical advice/attention Collect spillage
Storage
Store locked up
Precautionary statements
Disposal Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable
Other hazards
No information available. Contains Benzyl Alcohol Unknown acute toxicity No information available
