Levetiracetam Injection USP

Fresenius Kabi USA, LLC

Revision date : 2015-11-10

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GHS07 GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

64-19-7

Name of the chemical

acetic 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

Version

11/10/2015

Revision date

2015-11-10

Product name

Levetiracetam Injection USP

Product name

Levetiracetam Injection USP

Identification on the label/Trade name

Levetiracetam Injection USP | Manufacturer Distributed / Manufactured by Fresenius Kabi USA LLC

Manufacturer Name

Fresenius Kabi USA, LLC

Icons in SDS

GHS07 GHS08

Company Information

company name

Fresenius Kabi USA, LLC

GHS Information

Signal word

DANGER

Hazard Codes

Hazard statements (CLP)

H317, H336, H361, H362, H372

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

Signal word

DANGER. GHS Class Specific Target Organ Toxicity -STOT Repeated exposure RE. Category 1 (Oral, Nervous system). Reproductive toxicity. Category 2. Skin Sensitization. Category 1. Specific Target Organ Toxicity - STOT, Single Exposure SE. Category 3. Reproductive toxicity. Effects on or via lactation.

Hazard statements

Causes damage to organs through prolonged or repeated exposure. Suspected of damaging fertility or the unborn child. May cause an allergic skin reaction. May cause drowsiness or dizziness. 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. Use only outdoors or in a well-ventilated area. Contaminated work clothing should not be allowed out of the workplace. Wear protective gloves/protective clothing/eye protection/face 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. Call a POISON CENTER or doctor/physician if you feel unwell. Get medical advice/attention if you feel unwell. Specific treatment (see ... on this label). If skin irritation or rash occurs: Get medical advice/attention. Take off contaminated clothing and wash it before reuse. Store in a well-ventilated place. Keep container tightly closed. 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

Eye: Skin Contact with eyes may cause irritation. May cause skin irritation. Inhalation May cause irritation of respiratory tract. Ingestion May cause irritation. Signs/Symptoms The substance is used for the treatment of epilepsy and is generally well tolerated after repeated oral intake up to 3000 mg/day. The most frequently reported adverse events are drowsiness, weakness, and dizziness

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