Deferoxamine Mesylate for Injection (500 mg/Vial & 2 g/Vial)

Alvogen, Inc

Revision date : 2018-01-25

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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

231-791-2/7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Revision date

2018-01-25

Product name

Deferoxamine Mesylate for Injection (500 mg/Vial & 2 g/Vial)

Product Synonyms

N-[5-[3-[(5-aminopentyl)hydroxycarbamoyl] propionamido]pentyl]-3-[[5-(N- hydroxyacetamido) pentyl] carbamoyl]propionohydroxamic acid

1.2.1 Relevant identified uses

Pharmaceutical product used as acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias

Manufacturer Name

Alvogen, Inc

Emergency telephone

1-844-842-8672

Icons in SDS

GHS07 GHS08

Company Information

company name

Alvogen, Inc

GHS Information

Signal word

Danger!

Hazard Codes

Hazard statements (CLP)

H315, H317, H319, H334, H335

Hazard statements

Code

Statements

H315

Causes skin irritation

H317

May cause an allergic skin reaction

H319

Causes serious eye irritation

H334

May cause allergy or asthma symptoms or breathing difficulties if inhaled

H335

May cause respiratory irritation

Section 2

SECTION 2: Hazards identification

1999/45/EC EMERGENCY OVERVIEW

Product definition

This product a white to off-white lyophilized powder or cake with no odor

Health hazards

May cause skin irritation or sensitization. Contact with eyes may cause irritation. Inhalation of dust may cause irritation and possible respiratory sensitization. Flammability Hazards: This product is non-flammable Reactivity Hazards: None known

Environmental hazards

The Environmental effects of this product have not been investigated. Release of this product is not expected to have significant adverse effects in the aquatic environment. US DOT SYMBOLS

Signal word

Danger!

Classification according to GHS

Skin Irritant Category 2 Skin Sensitizer Category 1 Eye Irritant Category 2 Respiratory Sensitizer Category 1 STOT SE Category 3

Precautionary statements

H315 – Causes skin irritation P260: Do not breathe dust/fume/mist/vapors/spray H317 – May cause allergic skin reaction P262: Do not get in eyes, on skin or on clothing H319 - Causes serious eye irritation P264: Wash skin after handling. H334 – May cause allergy or asthma symptoms or breathing difficulties if inhaled H335 – May cause respiratory irritation 2.3 HEALTH HAZARDS OR RISKS FROM EXPOSURE: SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The most significant routes of exposure for this product are by injection, ingestion, inhalation and skin or eye contact. ACUTE: May cause skin irritation or sensitization. Contact with eyes may cause irritation. Inhalation of dust may cause irritation and possible respiratory sensitization. CHRONIC: Ocular and auditory disturbances have been reported when deferoxamine mesylate was given over prolonged periods of time at high doses. TARGET ORGANS Acute Eyes, Skin, Respiratory System Chronic Eyes, Auditory

2.1 Classification of the substance or mixture

EUROPEAN UNION DIRECTIVES: This product does not meet the definition of a hazardous substance or preparation as defined by 29 CFR 1910. 1200 AND the European Union Council Directives 67/548/EEC, 1999/45/EC, 1272/2008/EC and subsequent Directives. EU HAZARD CLASSIFICATION OF INGREDIENTS PER DIRECTIVE 1272/2008/EC: EC# 205-314-3 This substance is not classified in the Annex VI EC# 231-791-2 This substance is not classified in the Annex VI Substances not listed either individually or in group entries must be self classified. Component(s) Contributing to Classification(s) All Ingredients

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