Attachment 4 - Midazolam - SDS 9Mar2017.pdf

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING

Product Identifier

Material Name: Midazolam Injection (Hospira, Inc.)

Trade Name: Midazolam Injection Chemical Family: Benzodiazepine

Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Intended Use: Pharmaceutical product used as antianxiety agent

Details of the Supplier of the Safety Data Sheet

2. HAZARDS IDENTIFICATION

Classification of the Substance or Mixture GHS - Classification

Reproductive Toxicity: Category 1B Effects on or via lactation

Label Elements

Signal Word: Danger Hazard Statements: H360D - May damage the unborn child

H362 - May cause harm to breast-fed children

Precautionary Statements: P202 - Do not handle until all safety precautions have been read and understood P260 - Do not breathe dust/fume/gas/mist/vapors/spray P263 - Avoid contact during pregnancy/while nursing P264 - Wash hands thoroughly after handling P270 - Do not eat, drink or smoke when using this product P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned: Get medical attention/advice P405 - Store locked up P501 - Dispose of contents/container in accordance with all local and national regulations

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Hospira, A Pfizer Company 275 North Field Drive Lake Forest, Illinois 60045 1-800-879-3477

Hospira UK Limited Horizon Honey Lane Hurley Maidenhead, SL6 6RJ United Kingdom

Revision date: 29-Mar-2017

Emergency telephone number:

CHEMTREC (24 hours): 1-800-424-9300

Emergency telephone number:

International CHEMTREC (24 hours): +1-703-527-3887

Version: 1.0

Contact E-Mail: pfizer-MSDS@pfizer.com

SAFETY DATA SHEET

Other Hazards An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8).

Note: This document has been prepared in accordance with standards for workplace safety, which requires the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warning included may not apply in all cases.

Your needs may vary depending upon the potential for exposure in your workplace.

3. COMPOSITION / INFORMATION ON INGREDIENTS

Hazardous Ingredient CAS Number EU

EINECS/ELINCS

List

GHS Classification %

Hydrochloric Acid 7647-01-0 231-595-7 Press. Gas Skin Corr.1A (H314) Acute Tox.3 (H331)

SODIUM HYDROXIDE 1310-73-2 215-185-5 Skin Corr. 1A (H314) ** Midazolam 59467-70-8 261-774-5 Acute Tox. 4 (H302)

Repr. 1B (H360D) Lact. (H362)

</= 0.5

Additional Information: * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. In accordance with 29 CFR 1910.1200, the exact percentage composition of this mixture has been withheld as a trade secret.

For the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 16

4. FIRST AID MEASURES

Description of First Aid Measures Eye Contact: Flush eye(s) immediately with plenty of water. If irritation occurs or persists, get medical attention.

Skin Contact: Wash exposed area with soap and water, remove contaminated clothing and obtain medical assistance if irritation occurs.

Ingestion: Get medical attention. Do not induce vomiting unless directed by medical personnel. Never give anything by mouth to an unconscious person.

Inhalation: Remove to fresh air. If not breathing, give artificial respiration. Get medical attention.

Most Important Symptoms and Effects, Both Acute and Delayed Symptoms and Effects of Exposure:

For information on potential signs and symptoms of exposure, See Section 2 - Hazards Identification and/or Section 11 - Toxicological Information.

Medical Conditions Aggravated by Exposure:

None known

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Version: 1.0

Revision date: 29-Mar-2017 Material Name: Midazolam Injection (Hospira, Inc.)

Indication of the Immediate Medical Attention and Special Treatment Needed Notes to Physician: None

5. FIRE FIGHTING MEASURES

Extinguishing Media: Dry chemical, carbon dioxide, water spray or alcohol-resistant foam

Special Hazards Arising from the Substance or Mixture Hazardous Combustion Products:

May include oxides of carbon.

Fire / Explosion Hazards: May generate flammable vapors. Fine particles (such as dust and mists) may fuel fires/explosions.

Advice for Fire-Fighters During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.

6. ACCIDENTAL RELEASE MEASURES

Personal Precautions, Protective Equipment and Emergency Procedures Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.

Environmental Precautions Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

Methods and Material for Containment and Cleaning Up Measures for Cleaning / Collecting:

Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill area thoroughly.

Additional Consideration for Large Spills:

Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel.

7. HANDLING AND STORAGE

Precautions for Safe Handling Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protective equipment (see Section 8).

Wash thoroughly after handling. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases.

Potential points of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls. Avoid breathing vapor or mist.

Conditions for Safe Storage, Including any Incompatibilities Storage Conditions: Store as directed by product packaging.

Specific end use(s): Pharmaceutical drug product

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Control Parameters Refer to available public information for specific member state Occupational Exposure Limits.

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ACGIH Ceiling Threshold Limit: 2 ppm

Revision date: 29-Mar-2017 Material Name: Midazolam Injection (Hospira, Inc.)

Australia PEAK 5 ppm

7.5 mg/m3

Version: 1.0

Hydrochloric Acid

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

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Italy OEL - TWA 5 ppm 8 mg/m3

Material Name: Midazolam Injection (Hospira, Inc.)

Japan - OELs - Ceilings 2 ppm

3.0 mg/m3

Cyprus OEL - TWA

Latvia OEL - TWA 5 ppm 8 mg/m3

5 ppm 8 mg/m3

Version: 1.0

Lithuania OEL - TWA 5 ppm 8 mg/m3

Luxembourg OEL - TWA 5 ppm 8 mg/m3

Czech Republic OEL - TWA 8 mg/m3

Malta OEL - TWA 5 ppm 8 mg/m3

Netherlands OEL - TWA 8 mg/m3

Austria OEL - MAKs

Poland OEL - TWA 5 mg/m3

Estonia OEL - TWA 5 ppm 8 mg/m3

Portugal OEL - TWA 5 ppm 8 mg/m3

5 ppm 8 mg/m3

Romania OEL - TWA 5 ppm 8 mg/m3

Germany - TRGS 900 - TWAs

Slovakia OEL - TWA 5 ppm

8.0 mg/m3

2 ppm 3 mg/m3

Slovenia OEL - TWA 5 ppm 8 mg/m3

Spain OEL - TWA 5 ppm

7.6 mg/m3

Germany (DFG) - MAK 2 ppm

3.0 mg/m3

Switzerland OEL -TWAs 2 ppm

3.0 mg/m3

Belgium OEL - TWA

Vietnam OEL - TWAs 5 mg/m3

5 ppm 8 mg/m3

SODIUM HYDROXIDE

Greece OEL - TWA 5 ppm 7 mg/m3

ACGIH Ceiling Threshold Limit: 2 mg/m3

Revision date: 29-Mar-2017

Australia PEAK 2 mg/m3

Hungary OEL - TWA

Austria OEL - MAKs 2 mg/m3

8 mg/m3

Bulgaria OEL - TWA 2.0 mg/m3

Ireland OEL - TWAs 5 ppm 8 mg/m3

Bulgaria OEL - TWA 5 ppm

8.0 mg/m3

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Exposure Controls Engineering Controls: Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne contamination levels below the exposure limits listed above in this section.

Personal Protective Equipment:

Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Contact your safety and health professional or safety equipment supplier for assistance in selecting the correct protective clothing/equipment based on an assessment of the workplace conditions, other chemicals used or present in the workplace and specific operational processes.

Hands: Impervious disposable gloves (e.g. Nitrile, etc.) (double recommended) if skin contact with drug product is possible and for bulk processing operations. (Protective gloves must meet the standards in accordance with EN374, ASTM F1001 or international equivalent.)

Eyes: Wear safety glasses or goggles if eye contact is possible. (Eye protection must meet the standards in accordance with EN166, ANSI Z87.1 or international equivalent.)

Skin: Impervious disposable protective clothing is recommended if skin contact with drug product is possible and for bulk processing operations. (Protective clothing must meet the standards in accordance with EN13982, ANSI 103 or international equivalent.)

Respiratory protection: Under normal conditions of use, if the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL (e.g. particulate respirator with a full mask, P3 filter). (Respirators must meet the standards in accordance with EN136, EN143, ASTM F2704-10 or international equivalent.)

9. PHYSICAL AND CHEMICAL PROPERTIES

Solvent Solubility: No data available Water Solubility: No data available pH: 3.0 (2.5-3.5) Melting/Freezing Point (°C): No data available Boiling Point (°C): No data available.

Partition Coefficient: (Method, pH, Endpoint, Value)

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1 mg/m3

Latvia OEL - TWA 0.5 mg/m3

OSHA - Final PELS - TWAs: 2 mg/m3

Estonia OEL - TWA 1 mg/m3

Poland OEL - TWA 0.5 mg/m3

Revision date: 29-Mar-2017

Slovakia OEL - TWA 2 mg/m3

Physical State: Solution

Slovenia OEL - TWA 2 mg/m3

Color: Clear colorless

France OEL - TWA

Odor: No data available.

2 mg/m3

Odor Threshold: No data available.

Molecular Formula: Mixture

Sweden OEL - TWAs 1 mg/m3

Molecular Weight: Mixture

Material Name: Midazolam Injection (Hospira, Inc.)

Switzerland OEL -TWAs 2 mg/m3

Greece OEL - TWA

Midazolam

2 mg/m3

Version: 1.0

Pfizer Occupational Exposure Band (OEB):

OEB 4 (control exposure to the range of 1ug/m3 to <10ug/m3)

Hungary OEL - TWA 2 mg/m3

Czech Republic OEL - TWA

Japan - OELs - Ceilings 2 mg/m3

9. PHYSICAL AND CHEMICAL PROPERTIES

Decomposition Temperature (°C): No data available.

Evaporation Rate (Gram/s): No data available Vapor Pressure (kPa): No data available Vapor Density (g/ml): No data available Relative Density: No data available Viscosity: No data available

Flammablity:

Autoignition Temperature (Solid) (°C): No data available Flammability (Solids): No data available Flash Point (Liquid) (°C): No data available Upper Explosive Limits (Liquid) (% by Vol.): No data available Lower Explosive Limits (Liquid) (% by Vol.): No data available

10. STABILITY AND REACTIVITY

Reactivity: No data available Chemical Stability: Stable under normal conditions of use.

Possibility of Hazardous Reactions

Oxidizing Properties: No data available Conditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions.

Incompatible Materials: As a precautionary measure, keep away from strong oxidizers Hazardous Decomposition Products:

No data available

11. TOXICOLOGICAL INFORMATION

Information on Toxicological Effects General Information: The information included in this section describes the potential hazards of the individual ingredients.

Short Term: May cause eye irritation (based on components) . Active ingredient may be harmful if swallowed.

Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on nervous system and liver.

Known Clinical Effects: 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.

Acute Toxicity: (Species, Route, End Point, Dose)

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No data available

No data available

Revision date: 29-Mar-2017

SODIUM HYDROXIDE

Sodium chloride

No data available

Material Name: Midazolam Injection (Hospira, Inc.)

No data available

Version: 1.0

Sodium chloride

Midazolam

Rat Oral LD50 3000 mg/kg

Water, purified

No data available Hydrochloric Acid

11. TOXICOLOGICAL INFORMATION

Irritation / Sensitization: (Study Type, Species, Severity)

Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))

Genetic Toxicity: (Study Type, Cell Type/Organism, Result)

Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))

Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.

See below

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Midazolam

Embryo / Fetal Development Rabbit Oral 100 mg/kg/day NOAEL Not Teratogenic

Rat Oral LD50 215 mg/kg

Eye Irritation Rabbit Minimal

Material Name: Midazolam Injection (Hospira, Inc.)

Midazolam Bacterial Mutagenicity (Ames) Salmonella Negative

Skin Irritation Rabbit Non-irritating

Micronucleus Mouse Negative

Rat Para-periosteal LD50 75mg/kg

In Vitro Chromosome Aberration Human Lymphocytes Negative

Hydrochloric Acid

Version: 1.0

In Vitro Micronucleus Hamster Negative

Skin Irritation Severe

Midazolam

Mouse Oral LD50 4000 mg/kg

2 Year(s) Male Rat Oral, in feed 9 mg/kg/day NOAEL Benign, Thyroid, Tumors

Eye Irritation Severe

2 Year(s) Female Mouse Oral, in feed 9 mg/kg/day NOAEL Liver, Tumors

Sodium chloride Eye Irritation Rabbit Moderate

Midazolam

Hydrochloric Acid

Midazolam

IARC: Group 3 (Not Classifiable)

Reproductive & Fertility Rat Oral16 mg/kg/day NOAEL No effects at maximum dose

Skin Irritation Rabbit Mild

Embryo / Fetal Development Rat Oral 120 mg/kg/day NOAEL Not Teratogenic

Revision date: 29-Mar-2017

Embryo / Fetal Development Mouse Oral 120 mg/kg/day NOAEL Not Teratogenic

12. ECOLOGICAL INFORMATION

Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be avoided.

Toxicity: No data available

Persistence and Degradability: No data available

Bio-accumulative Potential: No data available

Mobility in Soil: No data available

13. DISPOSAL CONSIDERATIONS

Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater.

14. TRANSPORT INFORMATION

The following refers to all modes of transportation unless specified below.

Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.

15. REGULATORY INFORMATION

Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture

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CERCLA/SARA Hazardous Substances and their Reportable Quantities:

5000 lb 2270 kg

Version: 1.0

CERCLA/SARA - Section 302 Extremely Hazardous TPQs

500 lb

CERCLA/SARA - Section 302 Extremely Hazardous Substances EPCRA RQs

5000 lb

Hydrochloric Acid

California Proposition 65 Not Listed

Revision date: 29-Mar-2017

CERCLA/SARA 313 Emission reporting 1.0 %

Material Name: Midazolam Injection (Hospira, Inc.)

15. REGULATORY INFORMATION

16. OTHER INFORMATION

Text of CLP/GHS Classification abbreviations mentioned in Section 3

Acute toxicity, oral-Cat.4; H302 - Harmful if swallowed Reproductive toxicity-Cat.1B; H360D - May damage the unborn child Reproductive toxicity, effects on or via lactation; H362 - May cause harm to breast-fed children Skin corrosion/irritation-Cat.1A; H314 - Causes severe skin burns and eye damage Acute toxicity, inhalation-Cat.3; H331 - Toxic if inhaled

Data Sources: Publicly available toxicity information. Safety data sheets for individual ingredients.

Reasons for Revision: New data sheet.

Revision date: 29-Mar-2017

Prepared by:

Product Stewardship Hazard Communication

Pfizer Global Environment, Health, and Safety Operations

Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time.

End of Safety Data Sheet

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CERCLA/SARA 313 Emission reporting Not Listed

231-595-7

Version: 1.0

California Proposition 65 Not Listed

U.S. Drug Enforcement Administration: Schedule IV Controlled Substance

SODIUM HYDROXIDE

Standard for the Uniform Scheduling for Drugs and Poisons:

Schedule 4

Inventory - United States TSCA - Sect. 8(b)

EU EINECS/ELINCS List 261-774-5

CERCLA/SARA 313 Emission reporting Not Listed

Present

CERCLA/SARA Hazardous Substances and their Reportable Quantities:

1000 lb 454 kg

California Proposition 65 Not Listed

Australia (AICS): Present

Inventory - United States TSCA - Sect. 8(b) Present

Revision date: 29-Mar-2017

Australia (AICS): Present Standard for the Uniform Scheduling for Drugs and Poisons:

Schedule 5 Schedule 6

Standard for the Uniform Scheduling for Drugs and Poisons:

Schedule 5 Schedule 6

EU EINECS/ELINCS List 215-185-5

Material Name: Midazolam Injection (Hospira, Inc.)

Midazolam

EU EINECS/ELINCS List