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File Name: safety_vanderbilt_edu---pentamidine_mdi.asp
 
                                                                                     MATERIAL SAFETY DATA SHEET





                                                                                               Date Prepared: 08/06/1996

PENTAMIDINE METERED DOSE INHALER                                                               Date Reviewed: 08/06/1996

________________________________________________________________________________________________________

 1.    CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

      Product Identifier:   Pentamidine MDI

      General Use:     Antibiotic

      MANUFACTURER                                             EMERGENCY TELEPHONE NUMBER:

      American Pharmaceutical Partners, Inc.                   (708) 450-7500

      1101 Perimeter Drive

      Schaumburg, IL 60173-5837

      (847) 969-2700

________________________________________________________________________________________________________

 3.    HAZARD IDENTIFICATION

       PRIMARY ROUTES OF EXPOSURE - Inhalation, Eye/Skin Absorption and Ingestion.

       CHEMICAL LISTING AS CARCINOGEN: (NO)

       National Toxicology Program

       IARC Monographs

       OSHA

 4.    EMERGENCY AND FIRST AID PROCEDURES

       Inhalation: Move person to fresh air immediately. Give artificial

       respiration and cardiopulmonary resuscitation (CPR) if required. Seek

       medical attention.

       Ingestion: Flush mouth out with water immediately. Seek medical attention.

       Skin Contact: Remove contaminated clothing immediately. Flush area with

       water for at least 15 minutes. Seek medical attention.

       Eye Contact: Immediately flush with water for at least 15 minutes. Seek

       medical attention.

       For Adverse Drug Reaction Information call (847) 317- 1276.

 ________________________________________________________________________________________________________

 5.    FIRE FIGHTING MEASURES

       Fire and Explosion Data:

       Closed Cup Flash Pt.         NE

       Open Cup Flash Pt.           NE

       Fire Point                   NE

       Autoignition                 NE

       Lower Explosion Limit        NE

       Upper Explosion Limit        NE

       GENERAL HAZARD: When heated to decomposition it emits toxic fumes.

       FIRE FIGHTING INSTRUCTION: Water spray, dry chemical, carbon dioxide or foam as appropriate.

       FIRE FIGHTING EQUIPMENT: Wear self-contained breathing apparatus and protective clothing.

       HAZARDOUS COMBUSTION PRODUCTS: Smoke, and NOx fumes.

 ________________________________________________________________________________________________________

 6.    ACCIDENTAL RELEASE MEASURES

       CLEAN-UP: Wear recommended personal protective equipment. Use absorbent

       towels or booms to clean-up spill. Wipe surfaces clean and wash with soap

       and water.

 ________________________________________________________________________________________________________

 7. HANDLING AND STORAGE

     When handling pharmaceutical products, avoid all contact and inhalation of dust,

     fumes, mist, and/or vapors associated with the product.

 ________________________________________________________________________________________________________









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 8.    EXPOSURE CONTROLS/PERSONAL PROTECTION

       ENGINEERING CONTROLS:

       General room ventilation is usually satisfactory, use local

       exhaust ventilation when necessary.

       PERSONAL PROTECTION:

       Respirators - With satisfactory ventilation, respiratory protection not usually required.

       Eyes - Safety glasses or goggles recommended.

       Gloves - Disposable latex gloves recommended.

       Clothing - Disposable garments if direct skin contact is anticipated.

 ________________________________________________________________________________________________________

 9.    PHYSICAL AND CHEMICAL PROPERTIES

       Appearance/Odor other characteristics: Inhaler.

       Boiling Point:  NA                                   Vapor Density:     NA

       Melting Point:  NE                                   Percent Volatiles: NA

       Freezing Point: NA                                   pH:

       Vapor Pressure: NA                                   Molecular Weight:

       Note:                                                Solubility:        SOLUBLE

 ________________________________________________________________________________________________________

 10. STABILITY AND REACTIVITY

       Stability - Stable.

       Conditions/Materials to Avoid - Exposure to light or heat may cause

       Hazardous Polymerization - Will not occur.

 ________________________________________________________________________________________________________

 11.       TOXICOLOGY INFORMATION

       SIGNS & SYMPTOMS OF OVEREXPOSURE MAY INCLUDE:

       This product is intended for theraputic use only when prescribed by a

       physician. Potential adverse reactions from prescribed doses and overdoses

       are described in the package insert. Occupational exposure has not been

       fully investigated.

       MEDICAL CONDITIONS AGGRAVATED BY ACCIDENTAL EXPOSURE: Pre-existing

       skin and respiratory conditions.

       IMMEDIATE EFFECTS: Eye, skin and respiratory irritation have been experienced with patient administration. Inhaled

       adenosine has been reported to induce bronchoconstriction is asthmatic patients, but not in normal individuals.

       DELAYED EFFECTS: Studies in animals have not been performed to evaluate the carcinogenic potential of Adenocard

       (Adenosine). Adenosine tested negative for mutagenic potential in the Ames test. Adenosine is known to produce a variety of

       chromosomal alterations. Altered sperm counts and morphology have been shown

       in rats and mice with intraperitoneal injecton. Human reproductive studies

       have not been performed.

 ________________________________________________________________________________________________________

 12.       TRANSPORT INFORMATION

       UN/NA Number:        NA

       DOT Hazard Class:    NA

       Shipping Name:       NA

       Shipping Label:      NA

 ________________________________________________________________________________________________________

 13.       WASTE DISPOSAL

       Waste Disposal - Dispose of in accordance with federal, state and local

       regulations.

 ________________________________________________________________________________________________________









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 14. OTHER INFORMATION



       KEY TO ABBREVIATIONS:



       ACGIH - American Conference of Governmental Industrial Hygienists

       HEPA - High-Efficiency Particulate Air

       IARC - International Agency for Research on Cancer

       NA - Not Applicable

       NE - Not Established

       NG - Not Given

       NIOSH - National Institute for Occupational Safety and Health

       NTP - National Toxicology Program

       OSHA - Occupational Safety and Health Administration

       PEL - Permissable Exposure Limit

       PPM - Parts Per Million

       QS - Quantity Sufficient

       RCRA - Resource Conservation and Recovery Act

       STEL - Short Term Exposure Limit

       TLV - Threshold Limit Value



       The information contained herein pertains to this material. It is the responsibility of each individual party to determine for

       themselves the proper means of handling and using these materials based on their purpose and intended use. Fujisawa USA,

       Inc., assumes no liability resulting from the use of, or reliance upon the information contained in this material safety data sheet.

       This material safety data sheet does not constitute the guaranty or specification of the product.

 ________________________________________________________________________________________________________









10/25/01                                                                                                                        Page 3 of 3
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