Material Safety Data Sheet
1. PRODUCT IDENTIFICATION
Product Name Fluconazole Injection, USP
Product Use Medical Treatment; Antifungal Agent
Manufacturer Teva Parenteral Medicines, Inc.
Address 11 Hughes
Irvine, CA 92618-1902
Chemtrec Emergency No. 1-800-424-9300 (United States)
Fuconazole Injection, USP
1-202-483-7617 (International Collect)
Business Phone 1-800-729-9991
Website Address http://www.newsicor.com
Diflucan?br>
Common Names
2,4-difluoro-,1 璪is(1H-1,2,4-triazol-1-ylmethyl)benzyl alcohol
Chemical Name
Chemical Formula C13H12F2N6O
Chemical Family Synthetic triazole antifungal agent
How Supplied 200mg/100ml and 400mg/200ml in 100 and 200ml glass bottles
200mg/100ml and 400mg/200ml in 100 and 250 mL medical solution bags
Date of Preparation: December 6, 2005
2. COMPOSITION AND INGREDIENTS
EXPOSURE LIMITS IN AIR
CHEMICAL NAME CAS# % by wt OTHE
ACGIH OSHA IDLH
R
TLV STEL PEL STEL
Fluconazole 86386-73-4 0.2 NE NE NE NE NE NE
Sodium Chloride 7647-14-5 0.9 NE NE NE NE NE NE
Water (for injection) 7732-18-5 Balance NE NE NE NE NE NE
NE - Not Established C - Ceiling 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.
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Material Safety Data Sheet
3. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: Material is a clear, colorless solution. Eye irritant. May be
harmful if swallowed. Avoid contact with eyes, skin and clothing. Do not taste or swallow. Wash
thoroughly after handling.
Fluconazole Injection, USP
Symptoms of Overexposure by Route of Exposure: This material is intended for intravenous injection
under the supervision of physicians.
Inhalation: Inhalation of significant amounts of the product is not anticipated to occur because of the
small size of individual containers.
Contact with Skin or Eyes: Fluconazole is irritating to eyes and slightly irritating to the skin. Eye contact
may cause stinging, watering, redness, and swelling.
Ingestion: Although ingestion is not an anticipated route of occupational exposure, this material is
moderately toxic and may be harmful if swallowed. Symptoms similar to those identified under injection
may occur, including nausea, vomiting and abdominal pain.
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 nausea, vomiting and abdominal pain may occur. See
package insert for 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,
burning sensation, nausea, vomiting, diarrhea, headache and abdominal pain may occur.
Cancer: Animal studies suggest a possible carcinogenic potential to the liver (see Section 11).
Chronic: Fluconazole has cause reproductive and developmental effects in some animals (see Section
11).
Target Organs: This product may produce adverse effects on the liver (see Section 11).
Other Comments: Clinically or potentially significant drug interactions between Fluconazole and the
following agents/classes have been observed: Oral hypoglycemics, Coumarin-type anticoagulants,
Phenytoin, Cyclosporine, Rifampin, Theophylline, Terfenadine, Cisapride, Astemizole, Rifabutin and
Tacrolimus (see Physicians Desk Reference or package insert for details).
Pre-Existing Medical Conditions: Conditions aggravated by exposure may include liver disorders.
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Material Safety Data Sheet
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: Move victim away from exposure and into fresh air. If irritation or redness develops, flush
eyes with clean water and seek immediate medical attention. For direct contact, hold eyelids apart and
flush the affected eye(s) with clean water for at least 15 minutes. Seek medical attention.
Fuconazole Injection, USP
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.
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.
5. FIRE-FIGHTING MEASURES
Flash Point: No data Autoignition Temperature: No data
Flammable Limits (in air by volume, %): Lower: No data Upper: No data
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.
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Material Safety Data Sheet
5. FIRE-FIGHTING MEASURES cont...
NFPA HAZARD CLASS: Health: 2 (Moderate)
Flammability: 0 (Least)
Reactivity: 0 (Least)
6. ACCIDENTAL RELEASE MEASURES
Fluconazole Injection, USP
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 upwind and 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. Dike far ahead of spill for later recovery or disposal. Spilled material may be
absorbed into an appropriate absorbent material. Notify appropriate federal, state, and local agencies.
Immediate cleanup of any spill is recommended.
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.
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. Keep away from any incompatible materials or
conditions (see Section 10). Store between 5 and 30癈 (41-86癋). Product must not be used if it is
discolored or contains a precipitate.
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.
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Material Safety Data Sheet
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
Fluconazole Injection, USP
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: The use of a face shield and/or chemical goggles to safeguard against potential eye
contact, irritation, or injury is recommended.
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.
9. PHYSICAL and CHEMICAL PROPERTIES
Relative Vapor Density (air = 1): ND Evaporation Rate (n-BuAc=1): <1
Specific Gravity (water = 1): ND Melting/Freezing Point: ND
Solubility in Water: Soluble Boiling Point: 100癈 (212癋)
ND pH: 4.0 ?8.0
Vapor Pressure, mm Hg @ 25癈.
Odor Threshold: Odorless
.
Appearance and Color: Clear, Colorless Solution
ND = No Data
10. STABILITY and REACTIVITY
Stability: For glass bottles: Store between 860F (300C) and 410F (50C). Protect from freezing.
For medical solution bags (non-PVC flexible polymer bags): Store between 770F (250C) and 410F (50C).
Brief exposure up to 1040F (400C) does not adversely affect the product. Protect from freezing.
Materials With Which Substance is Incompatible: This product is generally compatible with other
common materials in a medical facility.
Hazardous Polymerization: Will not occur.
Conditions To Avoid: Protect from freezing.
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Materials Safety Data Sheet
11. TOXICOLOGICAL INFORMATION
Toxicity Data: The following information is for Fluconazole
IV LD50(rat) >200 mg/kg Oral LD50(mouse) = 1408 mg/kg IP LD50(rat) >941 mg/kg
IV LD50(dog) >100 mg/kg Oral LD50 (rat) = 1271 mg/kg IP LD50(mouse) =1273 mg/kg
IV LD50(mouse) >200 mg/kg Oral LD50 (dog) >300 mg/kg
Fluconazole Injection, USP
Suspected Cancer Agent: In long-term carcinogenicity studies in rats and mice, an increased incidence of
hepatocellular adenomas (benign) was reported in male rats treated at 5 and 10 mg/kg/day. This product
has NOT been identified as a carcinogen by NTP, IARC or OSHA.
Irritancy of Product: This product may be irritating to eyes and other tissues.
Sensitization to the Product: No data to indicate that it is a sensitizer.
Reproductive Toxicity Information: Listed below is information concerning the effects of Fluconazole on
human and animal reproductive systems. This material is classified as a Pregnancy Category C (Risk to
Fetus Cannot be Ruled-Out).
Mutagenicity: Negative in several short-term screening tests for genetic damage.
Embryotoxicity/Teratogenicity/Reproductive Toxicity: Did not produce birth defects in rabbits given
many times the maximum recommended human dose. Birth defects were noted in rats treated at
many times the maximum recommended human dose. This may be associated with a species-
specific estrogen lowering effect of fluconazole in rats. Did not impair fertility in rats at doses up to
20 mg/kg/day orally or 75 mg/kg/day parenterally. The onset of parturition and abnormal labor
occurred at some of the higher doses tested. These effects are thought to be due to a species-
specific estrogen lowering effect that has not been observed in women treated with fluconazole.
There are no adequate and well-controlled studies in pregnant women. There have been reports of
multiple congenital abnorrmalities in infants whose mothers were being treated for 3 or more months
with high dose (400-800 mg/day) of Fluconazole therapy for coccidioidomycosis (an unindicated use).
The relationship between Fluconazole use and these events is unclear.
Target Organ(s): Fluconazole has been associated with rare cases of serious hepatic toxicity, including
fatalities primarily in patients with serious underlying medical condition. In such cases, no obvious
relationship to total daily dose, duration of therapy, sex or age of the patient has been observed.
Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy.
ACGIH Biological Exposure Indices: Currently there are no Biological Exposure Indices (BEIs) associated
with the components of this product.
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Materials 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
Fluconazole on plants or animals in the environment.
Effect of Chemicals on Aquatic Life: No specific information is available on the effect of Fluconazole on
Fluconazole Injection, USP
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
15. REGULATORY INFORMATION
U.S. REGULATIONS
U.S. SARA Reporting Requirements: The components of this product are not subject to the reporting
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: Fluconazole is a "drug" as defined by the Federal Food, Drug and Cosmetic
Act and is therefore not a chemical substance under TSCA.
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Materials Safety Data Sheet
15. REGULATORY INFORMATION cont...
U.S. REGULATIONS
California Safe Drinking Water and Toxic Enforcement Act (Proposition 65): This product does NOT
contain a chemical 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
Fluconazole Injection, USP
Bloodborne Pathogen Standard (29 CFR 1910.1030) are applicable.
ANSI Labeling (Based on 129.1, Provided to Summarize Occupational Exposure Hazards):
CAUTION! EYE IRRITANT. HARMFUL IF SWALLOWED. Fluconazole should be administered
under the supervision of a qualified physician. Avoid over-exposure. Avoid contact with eyes, skin and
clothing. Do not eat, drink or smoke when handling Fluconazole. Do not taste or swallow. Wash
thoroughly after handling. Clean up spills promptly.
CANADIAN REGULATIONS
Canadian DSL/NDSL Status: Fluconazole is regulated by the Food and Drug Administration of Health
Canada and is therefore exempt from the requirements of CEPA.
16. OTHER INFORMATION
Issue Date: 12/06/05
Previous Issue Date: 10/31/02
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 OR
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.
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