Ondansetron Injection, USP

Fresenius Kabi USA, LLC

Revision date : 2023-11-01

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

Note: Ingredients listed on restricted chemical lists

EC/CAS

99-76-3

Name of the chemical

4-hydroxybenzoic acid, methyl ester

Concentration

N/A

EC/CAS

94-13-3

Name of the chemical

Propylparaben; propyl 4-hydroxybenzoate

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

11/01/2023

Revision date

2023-11-01

Product name

Ondansetron Injection, USP

Product name

Ondansetron Injection, USP

Identification on the label/Trade name

Ondansetron Injection, USP | Manufacturer 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, H334, H362

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

Signal word

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

Hazard statements

May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause an allergic skin reaction. May cause harm to breast-fed children.

Precautionary statements

Obtain special instructions before use. 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. 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 Contact with eyes may cause irritation. Signs/Symptoms Possible adverse reactions include: diarrhea, headache, fever, constipation, dizziness, musclemen pain, drowsiness, sedation, malaise, fatigue, shivers, injection site reaction, urinary retention, pain, chest pain, anxiety, dysuria, hypotension, fever, cold sensation, pruritus, and paresthesia. Flushing, rare cases of hypersensitivity reactions including anaphylaxis, bronchospasm, cardiopulmonary arrest, hypotension, laryngeal edema, laryngospasm, shock, shortness of breath, and stridor have also been reported. Local reactions such as pain, redness, and burning at the site of injection have been reported. Dystonic reactions including oculogyric crisis, urticaria, hiccups, transient dizziness, and transient blurred vision have also been reported. Transient blindness which resolved within a few minutes or up to 48 hrs was also reported. Occupational exposure has not been fully investigated. Overexposure in the workplace might have the following effects: symptoms of hypersensitivity, such as skin rash, hives, itching, and/or difficulty breathing, headache, constipation, flushing, and central nervous system activity. Aggravation of Pre-Existing Minor irritation might occur following direct contact with eyes. Adverse effects might occur in the central Conditions nervous system following overexposure.

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