CRESEMBA (isavuconazonium sulfate) for Injection

Astellas US LLC

Revision date : 2023-04-14

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GHS07 GHS08 GHS09
Health risk rating 4
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

69-65-8

Name of the chemical

D-mannitol C6H14O6

Concentration

<=20

EC/CAS

87-78-5

Name of the chemical

mannitol

Concentration

<=20

General Information

Version

2.1

Revision date

2023-04-14

Product name

CRESEMBA (isavuconazonium sulfate) for Injection

1.2.1 Relevant identified uses

Pharmaceutical research, manufacture of clinical drug product, and clinical use

Icons in SDS

GHS07 GHS08 GHS09 M004 M009 M010 M016

Company Information

company name

Astellas US LLC

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H302, H315, H319, H361, H372, H410

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

SECTION 2: Hazards identification

Classification (GHS-US) Classification of the Substance or Mixture Classification (GHS-US) Comb. Dust Acute Tox. 4 (Oral) H302 Skin Irrit. 2 H315 Eye Irrit. 2A H319 Repr. 2 H361 STOT RE 1 H372 Aquatic Chronic 1 H410

2.2 Label elements

GHS-US Labeling

Hazard pictograms

GHS07 GHS08 GHS09

Signal word

Warning

Hazard statements

May form combustible dust concentrations in air. H302 - Harmful if swallowed. H315 - Causes skin irritation. H319 - Causes serious eye irritation. H361 - Suspected of damaging the unborn child. H372 - Causes damage to organs (liver, adrenals, thyroid) through prolonged or repeated exposure. H410 - Very toxic to aquatic life with long lasting effects.

Precautionary statements

P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood. P260 - Do not breathe dust. P264 - Wash hands, forearms and face thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P273 - Avoid release to the environment. P280 - Wear eye protection, protective clothing, protective gloves. P301+P312 - If swallowed: Call a doctor, a POISON CENTER if you feel unwell. P302+P352 - If on skin: Wash with plenty of water. P305+P351+P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P308+P313 - If exposed or concerned: Get medical advice/attention. P314 - Get medical advice/attention if you feel unwell. P321 - Specific treatment (see Section 4 on this SDS). P330 - Rinse mouth. P332+P313 - If skin irritation occurs: Get medical advice/attention. P337+P313 - If eye irritation persists: Get medical advice/attention. P362+P364 - Take off contaminated clothing and wash it before reuse. P391 - Collect spillage. P405 - Store locked up. P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations.

Other hazards

Exposure may aggravate those with pre-existing eye, skin, or respiratory conditions

Ingredient(s) with unknown acute toxicity

No data available

2.1 Classification of the substance or mixture

Classification (GHS-US) Comb. Dust Acute Tox. 4 (Oral) H302 Skin Irrit. 2 H315 Eye Irrit. 2A H319 Repr. 2 H361 STOT RE 1 H372 Aquatic Chronic 1 H410

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