Bivalirudin for Injection

Meitheal Pharmaceuticals, Inc

Revision date : 2021-01-25

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GHS07
Health risk rating 2
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

≥25-≤50

EC/CAS

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

≤10

General Information

Version

Regulatory Affairs

Revision date

2021-01-25

Product name

Bivalirudin for Injection

supplier name

Meitheal Pharmaceuticals, Inc

Emergency telephone

844-824-8426 (Monday - Friday, 08 00 - 18 00 CST

Icons in SDS

GHS07

Company Information

company name

Meitheal Pharmaceuticals, Inc

e-mail address of the competent person responsible for the Safety Data Sheet

info@meithealpharma.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H315, H319

Hazard statements

Code

Statements

H315

Causes skin irritation

Section 2

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

COMBUSTIBLE DUSTS H315 SKIN IRRITATION - Category 2 H319 EYE IRRITATION - Category 2A

Signal word

Warning

Hazard statements

H315 - Causes skin irritation. SDS Title: SDS Number: Page Number: Bivalirudin for Injection Safety Data Sheet SDS-000042 Page 2 of 14 Function: Date of issue/ Date of Version number: Regulatory Affairs January 25, 2021 1.0

Prevention

P280 - Wear protective gloves. Wear eye or face protection. P264 - Wash thoroughly after handling.

Response

P362 + P364 - Take off contaminated clothing and wash it before reuse. P302 + P352 - IF ON SKIN: Wash with plenty of water. P332 + P313 - If skin irritation occurs: Get medical advice or attention. P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337 + P313 - If eye irritation persists: Get medical advice or attention.

Storage

Not applicable.

Disposal

Not applicable.

Supplemental label elements

Keep container tightly closed. Keep away from heat, hot surfaces, sparks, open flames elements and other ignition sources. No smoking. Prevent dust accumulation.

2.3 Other hazards

None known.

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