Gemcitabine Hydrochloride for Injection, Gemzar, Gemcin, Gemtro

Sagent Pharmaceuticals

Revision date : 2025-07-26

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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

87-78-5

Name of the chemical

mannitol

Concentration

48.5%

EC/CAS

7647-01-0

Name of the chemical

Hydrochloric acid

Concentration

N/A

EC/CAS

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

N/A

General Information

Version

9.0

Revision date

2025-07-26

Product name

Gemcitabine Hydrochloride for Injection, Gemzar, Gemcin, Gemtro

Chemical name

2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer)

1.2.1 Relevant identified uses

Pharmaceutical product used as antineoplastic

Icons in SDS

GHS07 GHS08 M004 M009 M010 M011 M013 M017

Company Information

company name

Sagent Pharmaceuticals

GHS Information

Signal word

WARNING

Section 2

SECTION 2: Hazards identification

OSHA Classification GHS Classification Acute Oral Toxicity (Category 4) Eye Irritation (Category 2B) Toxic to Reproduction (Category 2) Mutagenicity (Category 2) Target Organ Toxicity (Category 2)

Signal word

WARNING Symbols Hazard Statements Harmful if swallowed Suspected of damaging fertility or the unborn child Suspected of causing genetic defects May cause damage to the skin, eyes, nervous system, blood, liver, or kidney through prolonged or repeated exposure N/A Causes eye irritation

Prevention

- Obtain special instructions before use - Do not eat, drink or smoke when using this product - Do not handle until all safety precautions have been read and understood - Do not breathe dust/mist/vapors/spray - Wash hands thoroughly after handling

Response

- IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell - Rinse mouth - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical advice/attention - Wash hands after handling - IF exposed or concerned: Get medical attention/advice (d) Unknown Acute Toxicity: N/A

2.1 Classification of the substance or mixture

GHS Classification Acute Oral Toxicity (Category 4) Eye Irritation (Category 2B) Toxic to Reproduction (Category 2) Mutagenicity (Category 2) Target Organ Toxicity (Category 2) US OSHA Classification Irritant, Reproductive Toxin, Target Organ Toxin (b) Signal Word, Hazard (c) Description of Hazards

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