Topotecan Hydrochloride for Injection, USP

Fresenius Kabi USA, LLC

Revision date : 2017-11-21

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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

N/A

EC/CAS

87-69-4

Name of the chemical

L-(+)-tartaric acid

Concentration

N/A

General Information

Version

11/21/2017

Revision date

2017-11-21

Product name

Topotecan Hydrochloride for Injection, USP

Product name

Topotecan Hydrochloride for Injection, USP

Identification on the label/Trade name

Topotecan Hydrochloride for Injection, USP | Manufacturer Fresenius Kabi USA LLC

Manufacturer Name

Fresenius Kabi USA, LLC

Icons in SDS

M004 M009 M010 M011 M013 M017 M026 M059

Company Information

company name

Fresenius Kabi USA, LLC

Hazard Codes

Hazard statements (CLP)

H362

Hazard statements

Code

Statements

H362

May cause harm to breast-fed children

Section 2

SECTION 2: Hazards identification

GHS Class Reproductive toxicity. Effects on or via lactation.

Hazard statements

May cause harm to breast-fed children.

Precautionary statements

Obtain special instructions before use. Do not breathe dust/fume/gas/mist/vapours/spray. Avoid contact during pregnancy and while nursing. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. IF exposed or concerned: Get medical advice/attention. Emergency Overview This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert. Avoid contact with skin, eyes, nostrils and mouth.

Principle Routes of Exposure

Inhalation Ingestion Eye contact Skin Absorption. Injection.

Potential health effects

Caution - Potent pharmaceutical agent. May cause cancer. May produce adverse effects on the development of human offspring. Possible effects of overexposure in the workplace include: nausea; vomiting; diarrhoea; bone marrow toxicity. Eye Contact with eyes may cause irritation. Skin May cause irritation. Inhalation May cause irritation. Ingestion May be harmful if ingested. Signs/Symptoms Overexposure in the workplace might have the following effects: reduced white blood cell count; nausea; diarrhoea; vomiting; fatigue. Target Organs bone marrow and formation of blood cells Aggravation of Pre-Existing None generally recognized. Conditions

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