Regulation (February 11, 2015)

Fresenius Kabi USA, LLC

Revision date : 2024-09-04

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GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

General Information

Version

1.0

Revision date

2024-09-04

Product name

Regulation (February 11, 2015)

1.2.1 Relevant identified uses

Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation

Manufacturer Name

Gland Pharma Limited

Icons in SDS

GHS08 M004 M009 M010 M017

Company Information

company name

Fresenius Kabi USA, LLC

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H360

Hazard statements

Code

Statements

H360

May damage fertility or the unborn child

Section 2

SECTION 2: Hazards identification

Classification (GHS-US)

Reproductive toxicity Category 1B H360 Combustible Dust

2.2 Label elements

GHS‐US/CA Labeling

Hazard pictograms

GHS08

Signal word

Danger

Hazard statements

May form combustible dust concentrations in air. H360 ‐ May damage fertility or the unborn child.

Precautionary statements

P201 ‐ Obtain special instructions before use P202 ‐ Do not handle until all safety precautions have been read and understood. P280 ‐ Wear protective gloves, protective clothing, and eye protection. P308+P313 ‐ If exposed or concerned: Get medical advice/attention. P405 ‐ Store locked up. P501 ‐ Dispose of contents/container in accordance with local, regional, national, and international regulations.

Additional information

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Proper grounding procedures to avoid static electricity should be followed. Prevent dust accumulation (to minimize explosion hazard). Avoid generating dust.

2.3 Other hazards

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

Ingredient(s) with unknown acute toxicity

No additional information available

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