Note: Ingredients listed on restricted chemical lists
EC/CAS
9005-65-6
Name of the chemical
polyethyleneglycol sorbitan monooleate
Concentration
7-13
EC/CAS
100-51-6
Name of the chemical
Benzyl Alcohol
Concentration
1-5
General Information
Revision date
2014-02-04
Product name
Amiodarone Hydrochloride Injection, 50mg/mL
1.2.1 Relevant identified uses
Pharmaceutical. Antiarrhythmic drug. Use only as directed. Refer to product insert for usage
supplier name
Mylan Institutional LLC
Manufacturer Name
Mylan Institutional LLC
Emergency telephone
+1 877-446-3679
Icons in SDS
Company Information
company name
Mylan Institutional LLC
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H320, H361, H370
Hazard statements
Code
Statements
H320
Causes eye irritation
Section 2
SECTION 2: Hazards identification
Classification (GHS-US) 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. Pharmaceutical Agent – Handling of this product in its final form presents minimal occupational exposure risk.
Classification (GHS-US)
Eye Irrit. 2B H320 Repr. 2 H361 STOT SE 1 H370
2.2 Label elements
GHS-US labeling
Hazard pictograms
GHS08
Signal word
Danger
Hazard statements
H320 - Causes eye irritation H361 - Suspected of damaging fertility or the unborn child H370 - Causes damage to organs
Precautionary statements
P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood. P260 - Do not breathe dust/fume/gas/mist/vapors/spray. P264 - Wash hands, forearms, and exposed areas thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P280 - Wear protective gloves/protective clothing/eye protection/face protection. P305+P351+P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P308+P313 - If exposed or concerned: Get medical advice/attention. P321 - Specific treatment (see section 4). P337+P313 - If eye irritation persists: Get medical advice/attention. P405 - Store locked up. P501 - Dispose of contents/container according to local, regional, national, territorial, provincial, and international regulations.
Other hazards which do not result in classification
Cardiac effects. Amiodarone Hydrochloride Injection may cause a worsening of existing arrhythmias or precipitate a new arrhythmia. Refer to product insert for complete adverse drug interactions.
Ingredient(s) with unknown acute toxicity
Not available