Reclast

Sagent Pharmaceuticals

Revision date : 2025-03-06

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

69-65-8

Name of the chemical

D-mannitol C6H14O6

Concentration

4.95%

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

95%

General Information

Version

7.0

Revision date

2025-03-06

Product name

Reclast

Chemical name

(1-Hydroxy-2-imidazol-l-yl-phosphonoethyl) phosphonic acid monohydrate

1.2.1 Relevant identified uses

Treatment of Paget’s Disease

Icons in SDS

GHS08 M004 M010 M011 M017

Company Information

company name

Sagent Pharmaceuticals

GHS Information

Signal word

WARNING

Hazard Codes

Hazard statements (CLP)

H361fd

Hazard statements

Code

Statements

H361fd

Suspected of damaging fertility; Suspected of damaging the unborn child

Section 2

SECTION 2: Hazards identification

NFPA Rating Classification GHS Classification Toxic to Reproduction, Category 2 NFPA Rating

Health hazards

Fire Hazard Reactivity Hazard Signal Word, Hazard (c) Description of Hazards statement(s), Symbol(s), and/or Precautionary statement(s)

Signal word

WARNING Symbol GHS Hazard Statements H361fd Suspected of damaging fertility. Suspected of damaging the unborn child

Precautionary statements

P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned: Get medical attention/advice P501 - Dispose of contents/container in accordance with local/regional/national/international regulations (d) Unknown Acute Toxicity: N/A

2.1 Classification of the substance or mixture

GHS Classification: Toxic to Reproduction, Category 2 NFPA Rating Health Hazard 1 Fire Hazard 0 Reactivity Hazard 0 (b) Signal Word, Hazard (c) Description of Hazards

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