Material Safety Data Sheet
1. PRODUCT IDENTIFICATION
Tobramycin Sulfate Injection, USP
Product Name Tobramycin Injection, USP
Product Use Medical Treatment; Antibacterial
Manufacturer Teva Parenteral Medicines, Inc.
Address 11 Hughes
Irvine, CA 92618-1902
Chemtrec Emergency No. 1-800-424-9300 (United States)
1-202-483-7617 (International Collect)
Business Phone 1-800-729-9991
Website Address http://www.newsicor.com
Common Names Nebcin? Factor 6, NF 6
Chemical Name O-3-amino-3-deoxy-_-Dglucopyranosyl-(1.4)- O-[2,6-diamino- 2,3,6-trideoxy
Dribo-hexopyranosyl-(1.6)]-2-deoxy-L-streptamine, sulfate (2:5)(salt)
Chemical Formula (C18H37N5O9)2* 5H2SO4
Chemical Family Aminoglycoside antibiotics
How Supplied 40 mg/mL in 2 mL and 30 mL vials
Date of Preparation: December 22, 2005
2. COMPOSITION AND INGREDIENTS
EXPOSURE LIMITS IN AIR
CHEMICAL NAME CAS#
Wt% ACGIH OSHA Other
TLV STEL PEL STEL
Tobramycin Sulfate 49842-07-1 4 NE NE NE NE NE
Phenol 108-95-2 <1 5 ppm - Skin NE 5 ppm - NE NE
Ski
Sodium Metabisulfite 7681-57-4 <1 5 mg/m3 NE NE NE NE
Edetate Disodium 139-33-3 <1 NE NE NE NE NE
Water for Injection 7732-18-5 Balance NE NE NE NE NE
NE - Not Established
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.
1
Material Safety Data Sheet
3. HAZARD IDENTIFICATION
Tobramycin Sulfate Injection, USP
EMERGENCY OVERVIEW: Material is a clear, colorless solution. May cause allergic skin
and/or respiratory reactions. May be harmful to the kidneys and nervous system including hearing.
May be harmful to the fetus. Avoid exposure during pregnancy and while breast feeding. Avoid
contact with eyes, skin and clothing. Do not taste or swallow. Wash thoroughly after handling.
Symptoms of Overexposure by Route of Exposure: This material is intended for intravenous or
intramuscular 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: Contact may cause irritation. Effects may include stinging, watering, and
redness of the eyes and redness and a burning sensation on the skin. May cause allergic skin reactions.
Ingestion: Ingestion is not an anticipated route of occupational exposure. The active ingredient,
Tobramycin Sulfate, is of low toxicity. 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 nausea, vomiting, loss of appetite, increased thirst, muscle
twitching, hearing loss, dizziness, itching rash and headaches may occur. See package insert for other
adverse reactions associated with therapeutic doses of this product.
Other: This product contains sodium metabisulfite and the symptoms of hypersensitivity or sulfite allergy
may include rash, fever, respiratory difficulty or asthma-like symptoms.
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 nausea, vomiting, loss of appetite, increased thirst, muscle twitching, hearing loss,
dizziness, itching rash and headaches may occur.
Cancer: No long-term cancer studies identified.
Chronic: Potential hazard to the fetus (see Section 11).
Target Organs: Potential hazard to the kidney and nervous system (see Section 11).
Pre-Existing Medical Conditions: Pre-existing kidney and nervous system disorders may be aggravated
by exposure to this material.
2
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.
Tobramycin Sulfate Injection, USP
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.
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: 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: 2 (Moderate)
Flammability: 0 (Least)
Reactivity: 0 (Least)
3
Material Safety Data Sheet
6. ACCIDENTAL RELEASE MEASURES
Spill and Leak Response:
Tobramycin Sulfate Injection, USP
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. 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 excessive heat, direct sunlight
and any incompatible materials or conditions (see Section 10). Store at controlled room temperature
between 15-30癈 (59-86癋).
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.
4
Material Safety Data Sheet
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
Ventilation and Engineering Controls: Use with adequate ventilation. Follow standard medical product
handling procedures.
Tobramycin Sulfate Injection, USP
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.
9. PHYSICAL and CHEMICAL PROPERTIES
Relative Vapor Density (air = 1): Not applicable Evaporation Rate (n-BuAc=1): Similar to water
Specific Gravity (water = 1): Melting/Freezing Point:
1 @ 20癈 0癈 (32癋)
. Solubility in Water: Highly Boiling Point: 100癈 (212癋)
ND pH: 3.0-6.5
Vapor Pressure, mm Hg @ 25癈.
Odor Threshold: Odorless
Appearance and Color: Clear, colorless solution
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 acids or caustics.
Hazardous Polymerization: Will not occur.
Hazardous Combustion Products: Heat may cause product to decompose, destroying the product or
producing toxic fumes.
5
Material Safety Data Sheet
11. TOXICOLOGICAL INFORMATION
Toxicity Data: The following information is for Tobramycin Sulfate , the active ingredient:
Oral LD50(rat) > 7500 mg/kg IM LD50 (rat) = 913 mg/kg IP LD50 (rat) = 1030 mg/kg
IV LD50 (rat0 = 104 mg/kg SubQ LD50 (rat) = 969 mg/kg IM LD50 (mouse) = 440 mg/kg
Tobramycin Sulfate Injection, USP
IP LD50 (mouse) = 445 mg/kg IV LD50 (mouse) = 72.5 mg/kg IV LD50 (mouse) = 70 mg/kg
Oral LD50 (mouse) > 11.5 g/kg SubQ LD50 (mouse) = 676 mg/kg SubQ LD50 (pig) = 676 mg/kg
Carcinogenicity: No long-term cancer studies have been conducted on Tobramycin Sulfate. It is not listed
as carcinogenic by NTP, IARC or OSHA.
Irritancy of Product: This product is expected to be irritating to contaminated skin, eyes and other tissues.
Sensitization to the Product: Rare instances of allergic response after repeated clinical use has been
reported.
Target Organ Toxicity: Adverse effects on the kidney (e.g., increased or decreased frequency of urination
or amount of urine) and nervous system (e.g., hearing loss, numbness and convulsions) have been
reported.
Reproductive Toxicity Information: Listed below is information concerning the effects of Tobramycin Sulfate
on human and animal reproductive systems. This material is classified as a Pregnancy Category D
(Positive Evidence of Risk):
Mutagenicity: Negative in several short-term screening tests for genetic damage including the
Ames bacterial cell test for mutagenicity, mouse lymphoma mammalian cell forward mutation
test, chromosomal aberration test in Chinese hamster ovary cells, and mouse micronucleus test.
Embryotoxicity/Teratogenicity: Negative for birth defects in rats and rabbits administered
tobramycin parenterally at doses up to 100 mg/kg/day. Ototoxicity was evident in the offspring of
guinea pigs given tobramycin intramuscularly at a dose of 50 mg/kg/day. The State of California
under Proposition 65 has listed aminoglycosides as a class as developmental toxicants.
Reproductive Toxicity: Negative for fertility impairment in rats administered tobramycin
subcutaneously at doses up to 100 mg/kg/day.
ACGIH Biological Exposure Indices: Currently there are no Biological Exposure Indices (BEIs)
associated with the components of this product.
6
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.
Tobramycin Sulfate Injection, USP
Effect of Materials on Plants or Animals: No specific information is available on the effect of Tobramycin
Sulfate on plants or animals in the environment. Due to the small product size and dilute concentration of
the components, this product is not anticipated to cause adverse effects.
Effect of Chemicals on Aquatic Life: No specific information is available on the effect of Tobramycin
Sulfate on plants or animals in the aquatic environment. Due to the small product size, this product is not
anticipated to cause adverse effects.
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
7
Material Safety Data Sheet
15. REGULATORY INFORMATION
Tobramycin Sulfate Injection, USP
U.S. REGULATIONS
U.S. SARA Reporting Requirements: Phenol, a component of this product IS 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. TSCA Inventory Status: Tobramycin Sulfate 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 contains a chemical
which is known to the State of California to cause developmental effects: Tobramycin Sulfate.
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: Tobramycin Sulfate 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): Tobramycin
Sulfate should be administered under the supervision of a qualified physician. Avoid over-exposure. May
cause allergic reactions. Overexposure may be harmful to the liver. Avoid contact with eyes, skin and
clothing. Do not eat, drink or smoke when handling Tobramycin Sulfate. Do not taste or swallow. Wash
thoroughly after handling. Clean up spills promptly.
16. OTHER INFORMATION
Issue Date: 12/22/05
Previous Issue Date: 7/14/04
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.
8
|