Idarubicin Hydrochloride Injection

Fresenius Kabi USA, LLC

Revision date : 2015-06-01

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GHS07 GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

56-81-5

Name of the chemical

glycerol

Concentration

N/A

EC/CAS

7647-01-0

Name of the chemical

Hydrochloric acid

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

Idarubicin Hydrochloride Injection

Manufacturer Name

Fresenius Kabi USA, LLC

Icons in SDS

GHS07 GHS08

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: 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

Overexposure may cause damage to the heart, liver, kidneys, bone marrow and reproductive system. May be harmful to the fetus. Eye: Contact with eyes may cause irritation. Skin: May cause skin irritation. Inhalation: May cause irritation of respiratory tract. Inhalation of significant amounts of the product is not anticipated to occur because of the small size of individual containers. Ingestion: May cause irritation. Signs/Symptoms: Potential adverse reactions from prescribed doses and overdoses are described in the package insert. Effects may include stinging, watering, and redness of the eyes and redness and a burning sensation on the skin. High concentrations are irritating to tissues and may lead to local ulceration and necrosis. In case of over-exposure by injection, burning sensation, infection, hair loss, abdominal cramps, headaches, nausea, vomiting, diarrhea, blood system effects, cardiac arrest, and a variety of other health effects may occur. Death can occur in the event of a massive accidental overdose. Occupational exposure has not been fully investigated. Target Organs: This product may produce adverse effects on the heart, liver, kidney and bone marrow. Cardiac toxicity is more common in patients who have received prior anthracyclines or who pre-existing cardiac disease. Changes in hepatic and renal function tests have been observed. Severe myleosupression will occur in all patients given a therapeutic dose. Deaths due to infection and/or bleeding have been reported during the period of severe myleosuppression. Aggravation of Pre-Existing Skin, respiratory heart, liver, kidney, bone marrow and reproductive disorders. Cardiac toxicity is more Conditions: common in patients who have received prior anthracyclines or who have pre-existing cardiac disease.

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