Midazolam (CIV) Injection (With Preservative) 50 mg/10 mL

Hazard statements (CLP)

H302, H314, H317, H332, H335, H360D, H362

Code

Statements

H302

Harmful if swallowed

SECTION 2: Hazards identification

1999/45/EC EMERGENCY OVERVIEW

Product definition

This product is a clear, colorless liquid with no odor

Health hazards

Common adverse effects include respiratory depression, changes in blood pressure, headache, lightheadedness, dizziness and drowsiness, and dry mouth. This compound can cross the placenta in pregnant women. Secreted in human breast milk. 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

Oral Toxicity Category 4 Skin Corrosion/Irritation Category C Skin Irritant Category 2 Eye Irritant Category 2 Skin Sensitization Category 1 STOT SE Category 3 Reproductive Toxicity Category 2

Precautionary statements

H302: Harmful if swallowed P202: Do not handle until all safety precautions H314: Causes severe skin burns and eye damage have been read and understood. H317: May cause an allergic skin reaction P260: Do not breathe dust/fume/gas/mist/vapors/ H332: Harmful if inhaled spray H335: May cause respiratory irritation P263: Avoid contact during pregnancy/while nursing H360D: May damage the unborn child P264: Wash skin after handling. H362: May cause harm to breast-fed children

Response

P305+P351+P338 IF IN EYES Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing

Storage

P403+P235: Store in a well ventilated place. Keep cool

Disposal

P501: Dispose of contents/container in accordance with local/regional/national/international regulations Other Known Hazard(s): This mixture has not been tested to the criteria for PBT or vPvB in accordance with Annex VII. No other hazards known 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: Common adverse effects include respiratory depression, changes in blood pressure, headache, lightheadedness, dizziness and drowsiness, and dry mouth. This compound can cross the placenta in pregnant women. Secreted in human breast milk. CHRONIC: Use of this product may cause reproductive harm. Repeat-dose studies in animals have shown a potential to cause adverse effects on nervous system and liver. TARGET ORGANS Acute Skin, Eyes, Respiratory System Chronic: Reproduction, Liver, Nervous System

2.1 Classification of the substance or mixture

EUROPEAN UNION DIRECTIVES: This product does 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# 261-774-5 This substance is not classified in the Annex VI of Directive 67/548/EEC EC# 202-859-9 This substance is not classified in the Annex VI of Directive 67/548/EEC EC# 613-386-6 This substance is not classified in the Annex VI of Directive 67/548/EEC EC# 231-132-9 This substance is classified in the Annex VI of Directive 67/548/EEC, Index# 011-001-00-0 EC# 231-55-7 This substance is not classified in the Annex VI of Directive 67/548/EEC EC# 215-185-5 This substance is not classified in the Annex VI of Directive 67/548/EEC EC# 231-791-2 This substance is not classified in the Annex VI of Directive 67/548/EEC Substances not listed either individually or in group entries must be self classified.- Component(s) Contributing to Classification(s) All Ingredients 2.2 LABEL ELEMENTS: GHS Hazard Classification(s): Oral Toxicity Category 4 Skin Corrosion/Irritation Category C