Gadoterate Meglumine Injection

Fresenius Kabi USA, LLC

Revision date : 2022-08-02

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GHS07
Health risk rating 2
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Version

1.0

Revision date

2022-08-02

Product name

Gadoterate Meglumine Injection

Product Synonyms

D-glucitol,1-deoxy-1-(methylamino)-,[1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraaceto(4-)-.kappa.N1, .kappa.N4, kappa.N7, .kappa.N10, .kappa.O1, .kappa.O4, .kappa.O7, .kappa.O10]gadolinate(1-)(1:1) (Gd-DOTA)

Manufacturer Name

Fresenius Kabi USA, LLC

Emergency telephone

(800)255-3924, +1 (813)248-0585

Icons in SDS

GHS07 M004 M009 M010

Company Information

company name

Fresenius Kabi USA, LLC

e-mail address of the competent person responsible for the Safety Data Sheet

ibd@hengrui.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H315, H319

Hazard statements

Code

Statements

H315

Causes skin irritation

Section 2

SECTION 2: Hazards identification

Classification of the Substance or Mixture GHS-US/CA Classification Skin Irrit. 2 H315 Eye Irrit. 2A H319

Hazard statements

see section 16 : H315 - Causes skin irritation. H319 - Causes serious eye irritation.

2.2 Label elements

GHS-US/CA Labeling

Hazard pictograms

GHS07

Signal word

Warning

Precautionary statements

P264 - Wash hands, forearms, and other exposed areas thoroughly after handling. P280 - Wear protective gloves, protective clothing, and eye protection. P302+P352 - IF ON SKIN: Wash with plenty of water. P305+P351+P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P321 - Specific treatment (see section 4 on this SDS). P332+P313 - If skin irritation occurs: Get medical advice/attention. P337+P313 - If eye irritation persists: Get medical advice/attention. P362+P364 - Take off contaminated clothing and wash it before reuse.

Other hazards

Exposure may aggravate pre-existing eye, skin, or respiratory conditions.

Ingredient(s) with unknown acute toxicity

No additional information available

2.1 Classification of the substance or mixture

GHS-US/CA Classification Skin Irrit. 2 H315 Eye Irrit. 2A H319 Full text of hazard classes and H-statements : see section 16

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