Material Safety Data Sheet


1. PRODUCT IDENTIFICATION

Desmopressin Acetate Injection
Product Name
Medical Treatment: Antidiuretic
Product Use
Teva Parenteral Medicines, Inc.
Manufacturer
Desmopressin Acetate Injection


11 Hughes
Address
Irvine, CA 92618-1902

1-800-424-9300 (United States)
Chemtrec Emergency No.
1-202-483-7617 (International Collect)
1-800-729-9991
Business Phone
http:/ /www.newsicor.com
Website Address

DDAVP?
Common Names
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate salt
Chemical Name
trihydrate
C46H64N14O12 S2? ? C2H4O2 ? 3 H2O
Chemical Formula
Synthetic hormone
Chemical Family

4 ug/mL, 1 mL in 2mL vials
How Supplied

December 4, 2005
Date of Preparation:


2. COMPOSITION AND INGREDIENTS
EXPOSURE LIMITS IN AI CHEMICAL NAME CAS#
Wt% ACGIH OSHA Other
TLV CEIL PEL CEIL
Desmopressin Acetate, *1 ??g/m3
62357-86-2 0.0004 NE NE NE NE
USP TWA

Sodium Chloride 7647-14-5 0.9 NE NE NE NE NE

Hydrochloric Acid 7647-01-0 Trace NE 5 ppm NE 5 ppm NE

Water for Injection 7732-18-5 Balance NE NE NE NE NE


NE - Not Established C - Ceiling Limit * Innovator??s Exposure Limit

NOTE: All WHMIS required information is included. It is located in appropriate sections based on the ANSI Z400.1 format

CHEMTREC NUMBER: Use only in the event of a chemical emergency involving a spill, leak, fire, exposure or accident involving this drug.


3. HAZARD IDENTIFICATION

EMERGENCY OVERVIEW: Material is a clear, colorless, odorless liquid. Avoid contact
with eyes, skin and clothing. Do not taste or swallow. Wash thoroughly after handling.




1
 Material Safety Data Sheet


3. HAZARD IDENTIFICATION cont??
Symptoms of Overexposure by Route of Exposure: This material is intended for injection under the
supervision of physicians.
Inhalation: Inhalation of significant amounts of the product is not anticipated to occur because of the
Desmopressin Acetate Injection


small size of individual containers.
Contact with Skin or Eyes: Contact may cause irritation. Effects may include stinging, watering, and
redness of the eyes and redness, itching, and a burning sensation on the skin.
Ingestion: Ingestion is not an anticipated route of occupational exposure. Symptoms similar to those
identified under injection may occur.
Injection: Local redness and pain are the primary symptoms of accidental injection in an occupational
setting. Medical personnel are not anticipated to experience over-exposures to the therapeutic doses
of this product. However, effects including headache, nausea, abdominal pain, facial flushing, changes
in blood pressure and increased heart rate may occur. Severe allergic reactions including anaphylaxis
have been reported rarely with injection. See package insert for other adverse reactions associated
with therapeutic doses of this product.

Health Effects or Risks From Exposure (An explanation in lay terms):

Acute: The primary health effects anticipated in an occupational setting include irritation of eyes and
skin as well as redness and local swelling after accidental injection. In case of over-exposure by
injection, effects such as headache, nausea, abdominal pain, facial flushing, changes in blood pressure
and increased heart rate may occur.
Cancer: No long-term carcinogenicity studies were identified.
Chronic: None known.
Pre-Existing Medical Conditions: None known.


4. FIRST-AID MEASURES
Skin Exposure: Remove contaminated shoes and clothing and cleanse affected area(s) thoroughly by
washing with mild soap and water. If irritation or redness develops and persists, seek medical
attention.
Eye Exposure: If irritation or redness develops, move victim away from exposure and into fresh air.
Flush eyes with clean water and seek medical attention.

Inhalation: If respiratory symptoms develop, move victim away from source of exposure and into fresh
air. If symptoms persist, seek medical attention. If victim is not breathing, clear airway and
immediately begin artificial respiration. If breathing difficulties develop, oxygen should be administered
by qualified personnel. Seek immediate medical attention.

Ingestion: If swallowed, seek emergency medical attention. If victim is drowsy or unconscious and
vomiting, place on the left side with the head down and DO NOT give anything by mouth. If not vomiting
and professional advice is not available, DO NOT induce vomiting. If possible, do not leave victim
unattended and observe closely for adequacy of breathing.




2
 Material Safety Data Sheet


4. FIRST-AID MEASURES cont??

Victims of chemical exposure must be taken for medical attention. Take a copy of the MSDS to the
physician or health professional with victim. Physicians should refer to Section 11 (Toxicological
Information) as well as the Physicians Desk Reference for additional treatment information.
Desmopressin Acetate Injection


5. FIRE-FIGHTING MEASURES
Flash Point: Non-flammable Autoignition Temperature: Not applicable
Flammable Limits (in air by volume, %): Lower: Not applicable Upper: Not applicable

Fire Extinguishing Equipment: Use extinguishing agent suitable for type of surrounding fire.
Water Spray: OK Carbon Dioxide: OK Halon: OK
Foam: OK Dry Chemical: OK Other: Any "ABC" Class

Unusual Fire and Explosion Hazards: No unusual fire or explosion hazards are expected.
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Not sensitive.

Special Fire Fighting Procedures: For fires beyond the incipient stage, emergency responders in the
immediate hazard area should wear bunker gear. When the potential chemical hazard is unknown, in
enclosed or confined spaces, or when explicitly required by DOT, a self-contained breathing apparatus
should be worn. In addition, wear other appropriate protective equipment as conditions warrant (see
Section 8). Isolate immediate hazard area and keep unauthorized personnel out. Contain spill if it can
be done with minimal risk. Move undamaged containers from immediate hazard area if it can be done
with minimal risk. Cool equipment exposed to fire with water, if it can be done with minimal risk.

NFPA HAZARD CLASS: Health: 1 (Slight)
Flammability: 0 (Least)
Reactivity: 0 (Least)


6. ACCIDENTAL RELEASE MEASURES
Spill and Leak Response:

For small releases of this product, wear latex or nitrile gloves and safety glasses. Absorb spilled liquid
and rinse area thoroughly with soap and water.

For large or uncontrolled releases, stay away from spill. Isolate immediate hazard area and keep
unauthorized personnel out. Contain spill if it can be done with minimal risk. Wear appropriate protective
equipment including respiratory protection as conditions warrant (see Section 8). Prevent spilled material
from entering sewers, storm drains, other unauthorized treatment drainage systems, and natural
waterways. Notify appropriate federal, state, and local agencies. Immediate cleanup of any spill is
recommended.




3
 Material Safety Data Sheet


7. HANDLING and STORAGE

Work and Hygiene Practices: As with all chemicals, avoid getting this product ON YOU or IN YOU. Do
not eat, drink, smoke or apply cosmetics while handling the product. Wash hands thoroughly after
handling.
Desmopressin Acetate Injection


Particular care in working with this product must be practiced in pharmacies and other preparation areas,
during manufacture of this product, and during patient administration. Precautions should be taken
during the following activities:
Withdrawal of needles from drug vials.
Drug transfers using syringes and needles or filter straws.
Expulsion of air from drug-filled syringes.


Storage and Handling Practices: Employees must be trained to properly use the product. Ensure vials
are properly labeled. Store only in approved containers. Protect from light. Keep away from any
incompatible materials or conditions (see Section 10). Store refrigerated at temperatures between 2-8??C
(36-46??F).


Protective Practices During Maintenance of Contaminated Equipment: When cleaning non-disposable
equipment, wear latex or nitrile gloves (double gloving is recommended), goggles, and lab coat. Wash
equipment with soap and water. All needles, syringes, vials and other disposable items contaminated
with this product should be disposed of properly.


8. EXPOSURE CONTROLS - PERSONAL PROTECTION
Ventilation and Engineering Controls: Use with adequate ventilation. Follow standard medical product
handling procedures.
Respiratory Protection: Not normally required for routine, medical administration of this product. A
NIOSH certified air-purifying respirator with a type 95 filter may be used under conditions where airborne
concentrations are expected to be excessive. Protection provided by air purifying respirators is limited
(see manufacturer??s respirator selection guide). Use a positive pressure air supplied respirator if there is
potential for uncontrolled release, exposure levels are not known, or any other circumstances where air-
purifying respirators may not provide adequate protection. A respiratory protection program that meets
OSHA's 29 CFR 1910.134 and ANSI Z88.2 requirements must be followed whenever workplace
conditions warrant a respirator's use.
Eye Protection: Approved eye protection to safeguard against potential eye contact, irritation or injury is
recommended. Depending on conditions of use, a face shield may be necessary.
Hand Protection: Use latex, nitrile, or rubber gloves. Check gloves for leaks. Wash hands before and
after using gloves.
Body Protection: No special body protection required for routine, medical administration of this product.
Wear lab coat, gown, or smock, as appropriate for procedure.
Product Preparation Instructions for Medical Personnel: Follow standard procedure for handling
pharmaceutical materials and recommendations presented on the Package Insert.




4
 Material Safety Data Sheet


9. PHYSICAL and CHEMICAL PROPERTIES
Relative Vapor Density (air = 1): Not determined Evaporation Rate (n-BuAc=1): Not applicable
Specific Gravity (water = 1): 1 Melting/Freezing Point: Not determined
Solubility in Water: Soluble Boiling Point: Not determined
Not determined pH: 3.5-5.0
Vapor Pressure, mm Hg @ 25??C.
Desmopressin Acetate Injection


Odor Threshold: Odorless
.
Appearance and Color: Clear, colorless liquid

ND = No Data



10. STABILITY and REACTIVITY
Stability: Stable under normal conditions of storage and handling.
Materials With Which Substance is Incompatible: This product is generally compatible with other common
materials in a medical facility. Keep away from strong oxidizers.
Hazardous Polymerization: Will not occur.
Hazardous Combustion Products: Heat may cause product to decompose, destroying the product or
producing toxic fumes.


11. TOXICOLOGICAL INFORMATION
Toxicity Data: The following information is for Desmopressin Acetate, the active ingredient

IV LD50 (rabbit) > 50 ??g/kg IV LD50(mouse) > 2 mg/kg
IV LD50(rat) > 2 mg/kg Sub Q (LD50( > 2 mg/kg

Suspected Cancer Agent: No long-term animal studies were identified. It is not listed as carcinogenic by
NTP, IARC or OSHA.
Irritancy of Product: This product is expected to be mildly irritating to eyes and skin.
Sensitization to the Product: Severe allergic reactions including anaphylaxis have been reported rarely
with injection.
Reproductive Toxicity Information: Listed below is information concerning the effects of Desmopressin
Acetate on human and animal reproductive systems. This material is classified as a Pregnancy Category B
(No evidence of risk).

Mutagenicity: No data identified.
.
Embryotoxicity/Teratogenicity/Reproductive Toxicity: No data identified on potential to affect
fertility. Not a teratogen in rats and rabbits.

ACGIH Biological Exposure Indices: Currently there are no Biological Exposure Indices (BEIs) associated
with the components of this product.




5
 Material Safety Data Sheet


12. ECOLOGICAL INFORMATION
All work practices must be aimed at eliminating environmental contamination.
Environmental Stability: This product will be relatively stable under ambient environmental conditions.
Effect of Materials on Plants or Animals: No specific information is available on the effect of
Desmopressin Acetate Injection


Desmopressin Acetate on plants or animals in the environment.
Effect of Chemicals on Aquatic Life: No specific information is available on the effect of Desmopressin
Acetate on plants or animals in the aquatic environment.


13. DISPOSAL CONSIDERATIONS
Preparing Wastes for Disposal: This material, if discarded as produced, is not a RCRA ??listed?? or
??characteristic?? hazardous waste. Use resulting in chemical or physical change or contamination may
subject it to regulation as a hazardous waste. Along with properly characterizing all waste materials
consult state and local regulations regarding the proper disposal of this material.
U.S. EPA Waste Number: None


14. TRANSPORTATION INFORMATION
This Materials is not Hazardous as Defined by 49 CFR 172.101 by the U. S. Department of
Transportation
Proper Shipping Name: Not applicable
Hazard Class Number and Description: Not applicable
UN Identification Number: Not applicable
Packing Group: Not applicable
DOT Label(s) Required: Not applicable
North American Emergency Response Guidebook Number (1996): Not applicable.
MARINE POLLUTANT: No component of this product is listed as a Marine Pollutant (49 CFR 172.101,
Appendix B)
Transport Canada Transportation of Dangerous Goods Regulations: Not applicable




6
 Material Safety Data Sheet



15. REGULATORY INFORMATION

U.S. REGULATIONS
U.S. SARA Reporting Requirements: The components of this product are not subject to the reporting
Desmopressin Acetate Injection


requirements of Sections 302, 304 and 313 of Title II of the Superfund Amendments and Reauthorization
Act.
U.S. SARA Threshold Planning Quantity: Not applicable
U.S. CERCLA Reportable Quantities (RQ): Not applicable
U.S. TSCA Inventory Status: Desmopressin Acetate is a ??drug?? as defined by the Federal Food, Drug and
Cosmetic Act and is therefore not a chemical substance under TSCA.
California Safe Drinking Water and Toxic Enforcement Act (Proposition 65): This product does NOT
contain chemicals known to the State of California to cause cancer or reproductive effects ??
Other U.S. Federal Regulations: Based on this product??s use, the requirements of the OSHA Bloodborne
pathogen Standard (29 CFR 1910.1030) are applicable.


CANADIAN REGULATIONS
Canadian DSL/NDSL Status: Desmopressin Acetate is regulated by the Food and Drug Administration of
Health Canada and is therefore exempt from the requirements of CEPA.


ANSI Labeling (Based on 129.1, Provided to Summarize Occupational Exposure Hazards): Avoid contact
with eyes, skin and clothing. Do not taste or swallow. Wash thoroughly after handling. Avoid accidental
injection. Do not eat, drink or smoke when handling. Clean up spills promptly.


16. OTHER INFORMATION
Issue Date: 12/04/05
Previous Issue Date: 11/21/00

The information in this document is believed to be correct as of the date issued. HOWEVER, NO
WARRANTY OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, OR ANY
OTHER WARRANTY IS EXPRESSED OR IS TO BE IMPLIED REGARDING THE ACCURACY O COMPLETENESS OF THIS INFORMATION, THE RESULTS TO BE OBTAINED FROM THE USE OF
THIS INFORMATION OR THE PRODUCT, THE SAFETY OF THIS PRODUCT, OR THE HAZARDS
RELATED TO ITS USE. This information and product are furnished on the condition that the person
receiving them shall make his own determination as to the suitability of the product for his particular
purpose and on the condition that he assume the risk of his use thereof.




7


DESMOPRESSIN ACETATE