General Information
Revision date
2018-07-19
Product name
ZEMDRI TM
Product Synonyms
Plazomicin Injection 500 mg/10mL
Chemical name
Mixture; contains an aminoglycoside antibacterial
CAS No.
1380078-95-4
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product/ mixture packaged in final form for patient use
Icons in SDS
Company Information
company name
Achaogen, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
SDS@achaogen.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H334
Hazard statements
Code
Statements
H334
May cause allergy or asthma symptoms or breathing difficulties if inhaled
Section 2
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. The classification and labeling listed below is for bulk drug product. Globally Harmonized Respiratory sensitizer - Category 1. System [GHS]
2.2 Label elements
SECTION 2 - HAZARDS IDENTIFICATION …continued
Signal word
Danger
Hazard statements
H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled wear respiratory protection. P304 + P341 - IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations.
Precautionary statements
P261 - Avoid breathing mist or vapor. P285 - In case of inadequate ventilation
2.3 Other hazards
Plazomicin injection contains plazomicin sulfate, an aminoglycoside antibiotic indicated for intravenous (IV) treatment of bacterial infections. Common adverse effects associated with use in clinical trials for the treatment of complicated urinary tract infection or acute pyelonephritis include gastrointestinal (GI) upset (diarrhea, nausea, vomiting), decreased renal function, and headache. The aminoglycoside class is associated with kidney damage. High acute IV exposures of aminoglycosides have been associated with neuromuscular blockade. High repeat-dose IV exposures of aminoglycosides have been associated with damage to hearing and/or balance. Clinical cases of respiratory sensitization following inhalation of similar aminoglycosides have been reported. May cause adverse effects on the developing fetus. Serious allergic reactions, including anaphylaxis, have been reported for aminoglycosides. Note This mixture is classified as hazardous according to Regulation EC No 1272/2008 (EU CLP) and Hazard Communication Standard No. 1910.1200 (US OSHA). The ecological properties of this mixture have not been fully characterized.
