Oxaliplatin Injection

Fresenius Kabi USA, LLC

Revision date : 2015-06-01

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GHS07 GHS08
Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

110-15-6

Name of the chemical

succinic acid

Concentration

N/A

EC/CAS

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Revision date

2015-06-01

Product name

Oxaliplatin Injection

Manufacturer Name

Fresenius Kabi USA, LLC

Icons in SDS

Company Information

company name

Fresenius Kabi USA, LLC

GHS Information

Signal word

DANGER

Section 2

Signal word

DANGER. GHS Class: Respiratory sensitisation. Category 1. Reproductive toxicity. Category 2. Skin Sensitization. Category 1. Reproductive toxicity. Effects on or via lactation.

Hazard statements

May cause allergy or asthma symptoms or breathing difficulties if inhaled. Suspected of damaging fertility or the unborn child. May cause an allergic skin reaction. May cause harm to breast-fed children.

Precautionary statements

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not breathe dust/fume/gas/mist/vapours/spray. Avoid breathing 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. Contaminated work clothing should not be allowed out of the workplace. Wear protective gloves/protective clothing/eye protection/face protection. In case of inadequate ventilation wear respiratory protection. IF ON SKIN: Wash with plenty of water. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. IF exposed or concerned: Get medical advice/attention. Specific treatment (see ... on this label). If skin irritation or rash occurs: Get medical advice/attention. If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. Take off contaminated clothing and wash it before reuse. Store locked up. Dispose of contents/container in accordance with Local, State, Federal and Provincial regulations. Emergency Overview: WARNING! The drug substance Oxaliplatin is mutagenic, cytotoxic, neurotoxic and fetotoxic. The drug substance is a possible carcinogen and a severe eye irritant. 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.

Principle Routes of Exposure

Inhalation Ingestion Eye contact Skin Absorption. Injection.

Potential health effects

Eye: Contact with eyes may cause irritation. Signs/Symptoms: Anticipated signs of overexposure include nausea, vomiting, diarrhea, peripheral neurotoxicity (with cold sensitivity and rare laryngeal dysesthesias, sensation of difficulty with breathing or swallowing), and possible myelosuppression (low blood counts). Mucositis (sore mouth, or soreness of other mucous membranes) and transient elevation of liver enzymes have been observed. As with other platinum compounds allergic reactions have been observed. In therapeutic use very rare anaphylactoid reactions (severe, possibly life-threatening allergic reactions) have been observed. Aggravation of Pre-Existing Individuals with a history of known allergy to oxaliplatin or other platinum compounds. Conditions:

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