SECTION 1 : PRODUCT AND COMPANY IDENTIFICATION
Product Name: Vasopressin Injection, USP
Manufacturer Name: Fresenius Kabi Canada Ltd.
Address: 165 Galaxy Boulevard
Suite 100
Toronto, Ontario M9W 0C8
Canada
General Phone Number: 905-770-3711
CHEMTREC: 800-424-9300 (24 hours everyday).
Canutec: (613) 996-6666 (Canada 24 hours everyday).
HMIS

Health Hazard  2
Fire Hazard  1
Reactivity  1
Personal Protection  X

SECTION 2 : COMPOSITION/INFORMATION ON INGREDIENTS
Chemical Name CAS# Ingredient Percent     EC Num.
Vasopressin 50-57-7    20 USP units./mL
Chlorobutanol 57-15-8    5 mg/mL
Water for Injection 7732-18-5    – Quantity Sufficient. –

SECTION 3 : HAZARDS IDENTIFICATION

Emergency Overview: This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert.
Route of Exposure: Inhalation, Ingestion, Eye contact, Skin Absorption., Injection.
Potential Health Effects:
Eye: Contact with eyes may cause irritation.
Skin: May cause skin irritation.
Inhalation: May cause irritation of respiratory tract.
Ingestion: May cause irritation.
Signs/Symptoms: Potential adverse reactions from prescribed doses and overdoses are described in the package insert. Side effects from therapeutic doses may include: Anaphylaxis, cardiac arrest, arrhythmias, decreased cardiac output, angina, myocardial ischemia, peripheral vasoconstriction, abdominal cramps, nausea, vomiting, tremor, vertigo, pounding in head, bronchial constriction, sweating, urticaria, and cutaneous gangrene. This drug may produce water intoxication. The early signs are drowsiness, listlessness, and headaches which should be recognized to prevent terminal coma and convulsions. Occupational exposure has not been fully investigated.
Aggravation of Pre-Existing Conditions: Individuals with a history of anaphylaxis or hypersensitivity to the drug or its components.
SECTION 4 : FIRST AID MEASURES
Eye Contact: Immediately flush eyes with plenty of water for at least 15 to 20 minutes. Ensure adequate flushing of the eyes by separating the eyelids with fingers. Get immediate medical attention.
Skin Contact: Immediately wash skin with plenty of soap and water for 15 to 20 minutes, while removing contaminated clothing and shoes. Get medical attention if irritation develops or persists.
Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration or give oxygen by trained personnel. Seek immediate medical attention.
Ingestion: If conscious, flush mouth out with water immediately. Call a physician or poison control center immediately. Do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person.
Other First Aid: For Adverse Event Information, please call Vigilance: (905) 770-3711.

SECTION 5 : FIRE FIGHTING MEASURES
Flash Point: Not established.
Flash Point Method: Not established.
Auto Ignition Temperature: Not established.
Lower Flammable/Explosive Limit: Not established.
Upper Flammable/Explosive Limit: Not established.
Fire Fighting Instructions: Evacuate area of unprotected personnel. Use cold water spray to cool fire exposed containers to minimize risk of rupture. Do not enter confined fire space without full protective gear. If possible, contain fire run-off water.
Extinguishing Media: Use alcohol resistant foam, carbon dioxide, dry chemical, or water fog or spray when fighting fires involving this material.
Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Protective Equipment: As in any fire, wear Self-Contained Breathing Apparatus (SCBA), MSHA/NIOSH (approved or equivalent) and full protective gear.
Hazardous Combustion Byproducts: Thermal decomposition products may include smoke and toxic fumes. Oxides of carbon, oxides of nitrogen and other organic substances may be formed. Other undetermined low molecular weight hydrocarbon compounds may be released in small quantities depending upon specific conditions of combustion.

SECTION 6 : ACCIDENTAL RELEASE MEASURES
Personal Precautions: Evacuate area and keep unnecessary and unprotected personnel from entering the spill area.
Avoid personal contact and breathing vapors or mists. Use proper personal protective equipment as listed in Section 8.
Environmental Precautions: Avoid runoff into storm sewers, ditches, and waterways.
Methods for containment: Contain spills with an inert absorbent material such as soil, sand or oil dry.
Methods for cleanup: Absorb spill with inert material (e,g., dry sand or earth), then place in a chemical waste container. After removal, flush spill area with soap and water to remove trace residue.

SECTION 7 : HANDLING and STORAGE
Handling: When handling pharmaceutical products, avoid all contact and inhalation of vapor, mists and/or fumes. Use with adequate ventilation. Use only in accordance with directions.
Storage: Store at controlled room temperature 15 to 30°C (59 to 86°F). Do not freeze.
Work Practices: Facilities storing or utilizing this material should be equipped with an eyewash facility and a safety shower.
Hygiene Practices: Wash thoroughly after handling. Avoid contact with eyes and skin. Avoid inhaling vapor or mist.

SECTION 8 : EXPOSURE CONTROLS, PERSONAL PROTECTION – EXPOSURE GUIDELINES
Engineering Controls: General ventilation is sufficient if this product is being used in a controlled medical setting (clinic, hospital, medical office) for its sole intended parenteral (injection) purpose. Otherwise, use appropriate engineering control such as process enclosures, local exhaust ventilation, or other engineering controls including use of a biosafety cabinet / fume hood to control airborne levels below recommended exposure limits.
Eye/Face Protection: Chemical splash goggles. Wear a face shield also when splash hazard exist.
Skin Protection Description: Protective laboratory coat, apron, or disposable garment recommended.
Hand Protection Description: Wear appropriate protective gloves. Consult glove manufacturer’s data for permeability data.
Nitrile rubber or natural rubber gloves are recommended.
Respiratory Protection: No personal respiratory protective equipment is normally required when this product is being used/administered by a licensed healthcare practitioner (i.e. an end-user such as a clinician / doctor / nurse) for its sole intended parenteral (injection) purpose in a controlled medical setting. The need for respiratory protection will vary according to the airborne concentrations and environmental conditions. A NIOSH approved air-purifying respirator with an organic vapor cartridge or canister may be permissible under certain circumstances. Consult the NIOSH web site (http://www.cdc.gov/niosh/npptl/topics/respirators/) for a list of respirator types and approved suppliers.
Other Protective: Consult with local procedures for selection, training, inspection and maintenance of the personal protective equipment.

EXPOSURE GUIDELINES
Ingredient Guideline OSHA Guideline ACGIH Quebec Canada Ontario Canada Alberta Canada
Vasopressin  Not established.  Not established.  Not established.  Not established.  Not established.
Chlorobutanol  Not established.  Not established.  Not established.  Not established.  Not established.
Water for Injection  Not established.  Not established.  Not established.  Not established.  Not established.
Ingredient British Columbia Canada
Vasopressin  Not established.
Chlorobutanol  Not established.
Water for Injection  Not established.
SECTION 9 : PHYSICAL and CHEMICAL PROPERTIES
Physical State: Liquid.
Color: Colorless.
Boiling Point: Not established.
Melting Point: Not established.
Solubility: Soluble. in water.
Vapor Density: Not established.
Vapor Pressure: Not established.
Percent Volatile: Not established.
pH: 2.5 – 4.5
Molecular Formula: Mixture
Molecular Weight: 1084.23
Flash Point: Not established.
Flash Point Method: Not established.
Auto Ignition Temperature: Not established.

SECTION 10 : STABILITY and REACTIVITY
Chemical Stability: Stable under normal temperatures and pressures.
Hazardous Polymerization: Not reported.
Conditions to Avoid: Avoid direct sunlight, conditions that might generate heat, and sources of ignition. Avoid contact with incompatible materials.

SECTION 11 : TOXICOLOGICAL INFORMATION
Vasopressin :
RTECS Number: YW8659000
Chlorobutanol :
RTECS Number: UC0175000
Eye: Administration into the eye – Rabbit Standard Draize test: 9180 ug/30S [Mild] (RTECS)
Skin: Administration onto the skin – Rabbit Standard Draize test.: 850 ug [mild]
Ingestion: Oral – Rat LD50 – Lethal dose, 50 percent kill: 510 mg/kg [Details of toxic effects not reported other than lethal dose value] (RTECS)

SECTION 12 : ECOLOGICAL INFORMATION
Ecotoxicity: No ecotoxicity data was found for the product.
Environmental Stability: No environmental information found for this product.

SECTION 13 : DISPOSAL CONSIDERATIONS
Waste Disposal: Dispose of in accordance with Local, State, Federal and Provincial regulations.

SECTION 14 : TRANSPORT INFORMATION
DOT Shipping Name: Not Regulated.
DOT UN Number: Not Regulated.

SECTION 15 : REGULATORY INFORMATION
Canada Reg. Status: This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all of the information required by the Controlled Products Regulations.
Canada WHMIS: Controlled – Class: D2B Toxic
EINECS Number: 200-050-5
Chlorobutanol :
TSCA Inventory Status: Listed
EINECS Number: 200-317-6
Canada DSL: Listed
Water for Injection :
TSCA Inventory Status: Listed
Canada DSL: Listed

SECTION 16 : ADDITIONAL INFORMATION
HMIS Ratings:
HMIS Health Hazard: 2
HMIS Fire Hazard: 1
HMIS Reactivity: 1
HMIS Personal Protection: X
SDS Creation Date: January 15, 2011
SDS Revision Date: April 07, 2015
SDS Revision Notes: Manufacturer name and logo change.
SDS Format: ANSI