Tobramycin Sulfate for Injection



Tobramycin Sulfate for
Injection
Eli Lilly and Company Effective Date: 04-Jun-2004
Material Safety Data Sheet


Section 1 - Chemical Product and Company
Manufacturer's Emergency Phone:
Manufacturer:
1-317-276-2000
Eli Lilly and Company
CHEMTREC:
Lilly Corporate Center
1-800-424-9300 (North America)
Indianapolis, IN 46285
1-703-527-3887 (International)

Common Name: Tobramycin Sulfate for Injection

CAS Number(s): 79645-27-5
Chemical Name: D-Streptamine, O-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-->6)-O-[2,6-
diamino-2,3,6-trideoxy-alpha-D-ribo-
hexopyranosyl-(1-->4)]-2-deoxy-, sulfate (2:5) (salt)
Chemical Family: Aminoglycoside antibiotic
Chemical Formula: 2(C18 H37 N5 O9) . 5 (H2 S O4)
Molecular Weight: 1425.440000
Synonym(s): Tobramycin; Tobramycin Sulfate; Nebramycin Factor 6; 047663 Sulfate; Tobramycine;
Sterile Tobramycin Sulfate
Trademarks(s): Distobram; Lilly Tobra; Nebcine; Obracin; Tobracin; Tobra Label; Nebzin; Nebcin In;
Tobradistin; Tobramina; Tobragram; Nebcin; Tobra; Gernebcin; Tobrasix; Nebcina
Lilly Serial Number(s): 307274
Lilly Item Code(s): AM7040; DD7125; DD7126; DD7127; DD7128; FS7252; FS7253; VF0182;
VF0342; VL0797; VL0798; VL7008; VL7251; VL7602; VP7480

See attached glossary for abbreviations.


Section 2 - Composition / Information on Ingredients
Ingredient CAS
Tobramycin Sulfate for Injection 79645-27-5

Exposure Guidelines:
Tobramycin - LEG 350 micrograms/m3 TWA for 12 hours.



Section 3 - Hazards Identification



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Appearance: White to off-white powder
Physical State: Solid
Odor: Odorless



Emergency Overview
Emergency Overview Effective Date: 28-May-1993

Lilly Laboratory Labeling Codes:
Health 1 Fire 1 Reactivity 0

Primary Physical and Health Hazards: Suspect Allergen.

Caution Statement: Tobramycin Sulfate for Injection may cause allergic reactions.


Routes of Entry: Inhalation and skin contact.

Effects of Overexposure: Based on clinical data for tobramycin, allergic reactions might be
expected. The following events have been reported with therapeutic intravenous use of tobramycin:
nausea, dermatitis, rash, dizziness, ringing of the ears, hearing loss, kidney effects, blood effects, and
changes in serum liver enzyme levels and other clinical chemistry parameters. Aminoglycosides are
poorly absorbed from an intact gastrointestinal tract.

Medical Conditions Aggravated by Exposure: Hypersensitivity to aminoglycosides.

Carcinogenicity: No carcinogenicity data found. Not listed by IARC, NTP, ACGIH, or OSHA.


Section 4 - First Aid Measures
Eyes: Flush eyes with plenty of water. Get medical attention.

Skin: Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin with
plenty of soap and water. Get medical attention if irritation develops.

Inhalation: Move individual to fresh air. Get medical attention if breathing difficulty occurs. If not
breathing, provide artificial respiration assistance (mouth-to-mouth) and call a physician immediately.

Ingestion: Do not induce vomiting. Call a physician or poison control center. If available, administer
activated charcoal (6-8 heaping teaspoons) with two to three glasses of water. Do not give anything by
mouth to an unconscious person. Immediately transport to a medical care facility and see a physician.

Notes to Physician:
Tobramycin - In managing overdosage, consider the possibility of multiple drug overdoses, interaction
among drugs, and unusual drug kinetics in your patient. The initial intervention in a tobramycin
overdose is to establish an airway and ensure oxygenation and ventilation. Resuscitative measures



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should be initiated promptly if respiratory paralysis occurs. Patients who have received an overdose of
tobramycin and who have normal renal function should be adequately hydrated to maintain a urine
output of 3 to 5 mL/kg/hr. Fluid balance, creatinine clearance, and tobramycin plasma levels should be
carefully monitored until the serum tobramycin level falls below 2 mcg/mL. Patients in whom the
elimination half-life is greater than 2 hours or whose renal function is abnormal may require more
aggressive therapy. In such patients, hemodialysis may be beneficial.


Section 5 - Fire Fighting Measures
Flash Point: No applicable information found
UEL: No applicable information found
LEL: No applicable information found

Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon.

Unusual Fire and Explosion Hazards: As a finely divided material, may form dust mixtures in air
which could explode if subjected to an ignition source.

Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.


Section 6 - Accidental Release Measures
Spills: Vacuum material with appropriate dust collection filter in place. Be aware of potential for dust
explosion when using electrical equipment. If vacuum is not available, lightly mist material and remove
by sweeping or wet wiping. Wear protective equipment, including eye protection, to avoid exposure
(see Section 8 for specific handling precautions).


Section 7 - Handling and Storage
Storage Conditions: Controlled Room Temperature: 15 to 30 C (59 to 86 F).


Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.

Under normal use and handling conditions, no protective equipment is required. The following is
recommended for a production setting:

Respiratory Protection: Use an approved respirator.

Eye Protection: Safety glasses.

Ventilation: Laboratory fume hood or local exhaust ventilation.

Other Protective Equipment: Chemical-resistant gloves and body covering to minimize skin
contact. If handled in a ventilated enclosure, as in a laboratory setting, respirator and goggles or face



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shield may not be required. Safety glasses are always required.


Section 9 - Physical and Chemical Properties
Appearance: White to off-white powder
Odor: Odorless
Boiling Point: No applicable information found
Melting Point: Decomposes at about 287 C (549 F)
Density: No applicable information found
pH: 9-11 (10% aqueous)
Evaporation Rate: No applicable information found
Water Solubility: Soluble
Vapor Density: No applicable information found
Vapor Pressure: No applicable information found


Section 10 - Stability and Reactivity
Stability: Stable at normal temperatures and pressures.

Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid,
etc.).

Hazardous Decomposition: May emit toxic fumes when heated to decomposition.

Hazardous Polymerization: Will not occur.


Section 11 - Toxicological Information

Acute Exposure
Oral:
Tobramycin sulfate - Rat, 7000 mg/kg, no deaths, reduced activity, diarrhea.

Skin:
Tobramycin sulfate - Rabbit, 500 mg/kg, mortality, diarrhea.

Inhalation:
Tobramycin sulfate - Rat, 6800 mg/m3 for 1 hour, no deaths or toxicity.

Intravenous:
Tobramycin sulfate - Rat, median lethal dose 133 mg/kg, convulsions, reduced activity.
Dog, 100 mg/kg, no deaths, vomiting.

Skin Contact:
Tobramycin sulfate - Rabbit, slight irritant




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Eye Contact:
Tobramycin sulfate - Rabbit, slight irritant

Chronic Exposure
Target Organ Effects:
Tobramycin sulfate - Kidney effects (increased blood urea nitrogen, increased creatinine, kidney tissue
changes).

Reproduction:
Tobramycin sulfate - No effects identified in animal studies.

Sensitization: No applicable information found.

Mutagenicity:
Tobramycin sulfate - Negative in bacterial cells.


Section 12 - Ecological Information
No applicable ecological information found.


Section 13 - Disposal Considerations
Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws
and regulations.


Section 14 - Transport Information
Regulatory Organizations:

DOT: Not Regulated

ICAO/IATA: Not Regulated

IMO: Not Regulated


Section 15 - Regulatory Information
Below is selected regulatory information chosen primarily for possible Eli Lilly and Company
usage. This section is not a complete analysis or reference to all applicable regulatory
information. Please consider all applicable laws and regulations for your country/state.

U.S. Regulations
TSCA - No




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CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No

EU Regulations
EC Classification
Not assigned an overall EC classification.


Section 16 - Other Information
MSDS Sections Revised: Sections 2, 3, 4, and 11.

As of the date of issuance, we are providing available information relevant to the handling of this
material in the workplace. All information contained herein is offered with the good faith belief that it
is accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE
ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY O FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this
material, this safety data sheet is not intended to be a substitute for consultation with appropriately
trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which
may accompany the finished product.

For additional information contact:
Eli Lilly and Company
Hazard Communication
317-277-6029

For additional copies contact:
Eli Lilly and Company
1-800-LILLY-Rx (1-800-545-5979)

GLOSSARY:

ACGIH = American Conference of Governmental Industrial Hygienists
AIHA = American Industrial Hygiene Association
BEI = Biological Exposure Index
CAS Number = Chemical Abstract Service Registry Number
CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)
CHAN = Chemical Hazard Alert Notice
CHEMTREC = Chemical Transportation Emergency Center
DOT = Department of Transportation
EC = European Community
EINECS = European Inventory of Existing Chemical Substances
ELINCS = European List of New Chemical Substances
EPA = Environmental Protection Agency
HEPA = High Efficiency Particulate Air (Filter)
IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association



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IEG = Lilly Interim Exposure Guideline
IMO = International Maritime Organization
Kow = Octanol/Water Partition Coefficient
LEG = Lilly Exposure Guideline
LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
MSHA = Mine Safety and Health Administration
NA = Not Applicable, except in Section 14 where NA = North America
NADA = New Animal Drug Application
NAIF = No Applicable Information Found
NCI = National Cancer Institute
NIOSH = National Institute for Occupational Safety and Health
NOS = Not Otherwise Specified
NTP = National Toxicology Program
OSHA = Occupational Safety and Health Administration
PEL = Permissible Exposure Limit (OSHA)
RCRA = Resource Conservation and Recovery Act
RQ = Reportable Quantity
RTECS = Registry of Toxic Effects of Chemical Substances
SARA = Superfund Amendments and Reauthorization Act
STEG = Lilly Short Term Exposure Guideline
STEL = Short Term Exposure Limit
TLV = Threshold Limit Value (ACGIH)
TPQ = Threshold Planning Quantity
TSCA = Toxic Substances Control Act
TWA = Time Weighted Average/8 Hours Unless Otherwise Noted
UEL = Upper Explosive Limit
UN = United Nations
WEEL = Workplace Environmental Exposure Level (AIHA)




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Tobramycin sulfate