Preparation of Technetium Tc 99m Mebrofenin, an intravenous injection hepatobiliary imaging agent.

Preparation of Technetium Tc 99m Mebrofenin, an intravenous injection hepatobiliary imaging agent.
Bracco Diagnostics, Inc.

Choletec Kit For The Preparation Of Technetium Tc 99m Mebrofenin (Vials Containing Lyophilized Powder)

MSDS Name: Choletec Kit For The Preparation Of Technetium Tc 99m Mebrofenin (Vials Containing Lyophilized Powder)
Manufacturer Name: Bracco Diagnostics, Inc.
Address:
P.O. Box 5225
Princeton, NJ 08543

EMERGENCY CONTACTS: (Health) 1-800-257-5181.
(U.S. Transportation)Chemtrec 1-800-424-9300.
(International Transportation) Chemtrec 1-703-527-3887.
Manufacturer MSDS Revision Date: December 22, 2000
Supersedes: March 6, 1992
Trade Names:
Product Identification: CHOLETEC Kit for the Preparation of Technetium Tc 99m Mebrofenin (vials containing lyophilized powder)
Synonyms:
For active, mebrofenin: stannous trimethylbromo HIDA.
CAS Number: Mebrofenin (78266-06-5).
Chemical Family: Iminodiacetic acid (HIDA) derivative.
General Use:
Preparation of Technetium Tc 99m Mebrofenin, an intravenous injection hepatobiliary imaging agent.
Chemical Name: For active, mebrofenin. (2,2''-[[2-[(3-Bromo- 2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino]bisacetic acid).

How Supplied: Kits of 10 sterile multidose reaction vials containing lyophilized powder.

Molecular Formula: C15H19BrN2O5.

The author of this Material Safety Data Sheet (MSDS) is Bracco Diagnostics Inc. This MSDS is generated and/or distributed by the Bristol-Myers Squibb Company on behalf of Bracco Diagnostics Inc. Please carefully review all of the information disclosed in this MSDS prior to handling or using the product referenced above.

EMERGENCY OVERVIEW:
Vials containing powder. See Health Effects and Toxicology sections for additional information.

HDR####


Product Codes:
SECTION 2 : COMPOSITION, INFORMATION ON INGREDIENTS
Chemical Name
Mebrofenin
CAS#
78266-06-5
% Weight
CONCENTRATION: 78%

COMPONENTS: > 1%

Components present at < 1% or used for pH adjustment: Not applicable.
SECTION 3 : HAZARDS IDENTIFICATION
Emergency Overview:
Vials containing powder. See Health Effects and Toxicology sections for additional information.
Applies to All Ingredients:
Route of Exposure:
Inhalation, Skin Contact, Ingestion
Potential Health Effects:
Eye Contact:
May cause irritation.
Skin Contact:
Exposure may occur via skin contact if gloves and protective clothing are not worn. The extent of systemic absorption of the material after skin contact is not known.

Toxic: Contact with small quantities of material for short periods is not expected to result in pharmacologic or toxic effects.

Irritation: Material contains components that are irritants. It may have potential to cause mild irritation, however, moderate or severe irritation is not expected.
Inhalation:
Under normal conditions, this material is handled in closed vials and exposure by inhalation is not expected to occur.

Acute: Formulation contains some materials that are irritants. Inhaling small amounts of dust may result in irritation.
Ingestion:
Ingestion of large quantities of this material in an occupational setting would not be expected to occur. Ingestion of trace amounts of the material might occur if the material contacts hands and hands are not washed prior to eating, drinking or smoking. The extent of systemic absorption after ingestion is not known.

Acute: Inadvertent ingestion of trace amounts of this material would not be expected to result in symptoms.
Chronic Health Effects:
Repeated and prolonged exposure to skin may cause skin irritation.
Carcinogenicity:
OSHA Designation:
No
NTP Designation:
No
IARC Designation:
No
Sensitizer Information:
Skin: This material may act as a sensitizer (allergen) for those persons who are allergic to the formulation or components in the formulation.
Target Organs:
None known.
Aggravation of Pre-Existing Conditions:
Skin disorders may be aggravated by irritant materials.

Exposure Guideline Summary: An exposure guideline has not been established for this material.
SECTION 4 : FIRST AID MEASURES
Eye Contact:
Hold eyelids apart and flush with plenty of water for 5 minutes. Get medical attention if signs of irritation develop.
Skin Contact:
Remove contaminated clothing. Wash skin with plenty of water for 5 minutes. Seek medical attention if irritation (redness, itching or swelling) develops or persists.
Inhalation:
Remove exposed person to fresh air. If person is not breathing, give artificial respiration. If breathing is difficult administer oxygen. Get medical attention immediately.
Ingestion:
Get medical attention immediately. Vomiting may be induced if a person is conscious and if ingestion has occurred within the past three hours. Never induce vomiting in a person who is unconscious or experiencing convulsions.
Note to Physicians:
None.
SECTION 5 : FIRE FIGHTING MEASURES
Flash Point:
Not available.
Upper Flammable or Explosive Limit:
Not applicable.
Lower Flammable or Explosive Limit:
Not applicable.
Auto Ignition Temperature:
Not available.
Extinguishing Media:
In case of fire, flood with water.
Hazardous Combustion Byproducts:
Combustibility of Dusts: Not available.

Carbon monoxide, carbon dioxide, hydrogen bromide, hydrogen chloride, hydrogen cyanide, hydrogen fluoride, nitrogen oxides.
Fire Fighting Instructions:
Firefighters should wear self-contained breathing apparatus, flame and chemical resistant clothing, boots and gloves. Evacuate personnel to an upwind direction, remove unneeded material and cool container(s) with water from a maximum distance.
Sensitivity to Impact:
Explosion data relative to mechanical impact: No information.
Static Discharge Effects:
Explosion data relative to static discharge: No information.
Unusual Fire Hazards:
None.
SECTION 6 : ACCIDENTAL RELEASE MEASURES
Spill Cleanup Measures:
Lab coat, impermeable gloves (latex, latex/nitrile or nitrile) and eye protection should be worn as a minimum precaution. Sweep material onto paper and place into a fiber drum for reclamation or disposal. The spill area should be ventilated and decontaminated after material has been picked up.
SECTION 7 : HANDLING and STORAGE
Handling:
Avoid skin and eye contact.
Container Requirements: Kits of 10 reaction vials.
Storage:
Conditions: Store at 20-25 deg C.
Hygiene Practices:
Wash hands after handling product and before eating, smoking, using lavatory and at the end of the day.
SECTION 8 : EXPOSURE CONTROLS, PERSONAL PROTECTION
Ventilation System:
None beyond good room ventilation.
Hand Protection Description:
Protective Gloves: Wear impervious gloves (latex, latex/nitrile, or nitrile) if the potential exists for dermal contact.
Eye/Face Protection:
Wear safety glasses (ANSI Z87.1).
Protective Clothing/Body Protection:
Special Clothing: None.
Respiratory Protection:
Not anticipated for normal clinical environment. Non-routine exposure conditions may require NIOSH approved respiratory protection appropriate for exposure potential. Self-contained breathing apparatus should be available for emergency use.
Exposure Limits:
Exposure Guideline Summary: An exposure guideline has not been established for this material.

Hygiene: Wash hands after handling product and before eating, smoking, using lavatory and at the end of the day.
SECTION 9 : PHYSICAL AND CHEMICAL PROPERTIES
Physical State/Appearance:
Powder
pH:
4.2 to 5.7 (reconstituted solution)
Vapor Pressure:
Minimal, material exists as a solid.
Vapor Density:
Not available
Boiling Point:
Not applicable.
Freezing Point:
Not available
Melting Point:
198-200 deg C
Solubility:
In water: Soluble
Specific Gravity:
Not available for lyophile, for reconstituted solution, 1.018
Evaporation Point:
Not applicable.
Viscosity:
(cp): Not applicable
Odor Threshold:
Not available
Coefficient of Water/Oil Distribution:
Octanol/Water Partition Coefficient: Not available.
Flashpoint:
Not available.
Auto Ignition Temp:
Not available.
Upper Flammable Explosive Limit:
Not applicable.
Lower Flammable Explosive Limit:
Not applicable.
SECTION 10 : STABILITY AND REACTIVITY
Chemical Stability:
Filled containers are stable under normal conditions. Shelf-life indicated on individual containers.
Incompatibilities with Other Materials:
None known.
Reactivity:
Conditions of Reactivity: Reactive with metals as chelating or complexing agent.
Hazardous Polymerization:
None.
Hazardous Decomposition Products:
Carbon monoxide, carbon dioxide, hydrogen bromide, hydrogen chloride, hydrogen cyanide, hydrogen fluoride, nitrogen oxides.

Explosion data relative to mechanical impact: No information.
Explosion data relative to static discharge: No information.
SECTION 11 : TOXICOLOGICAL INFORMATION
Applies to All Ingredients:
Acute Health Effects:
Acute iv LD50 (mouse) = 213.8 mg/kg
Acute iv LD50 (rat) = 226.4 mg/kg
Carcinogenicity:
No information.
Mutagenicity:
No information.
Teratogenicity:
No information.
Reproductive Toxicity:
No information.
Other Toxicological Information:
RTECS ## (U.S.): MB9121850

Toxicological Synergistic Products: No information.
Toxicological Paragraph:
TOXICOLOGICAL INFORMATION - For active ingredient, mebrofenin.
SECTION 12 : ECOLOGICAL INFORMATION
Ecotoxicity:
Not available.

Chemical Fate Information:
Not available.
SECTION 13 : DISPOSAL CONSIDERATIONS
Waste Disposal:
Dispose in accordance with national, state, local or applicable country regulations.
SECTION 14 : TRANSPORT INFORMATION
Transportation Information:
International:
Proper Shipping Name: Not classified.
Hazard Class, UN Number, Packing Group: Not classified.
Label Requirements: Not applicable.
Placard Requirements: Not applicable.
DOT Shipping Information:
Domestic:
Placard Requirements: Not applicable.
DOT Shipping Name:
Not classified.
DOT UN Number:
Not classified.
DOT Hazard Class: Not classified.
DOT Packing Group: Not classified.
DOT Subpart E Labeling Requirement: Not applicable.
SECTION 15 : REGULATORY INFORMATION
Applies to all ingredients:
US Federal:
None noted.
Regulatory Paragraph:
REGULATORY/STATUTORY INFORMATION (Limited to health, safety, environmental)
European Community Chemical Inventory Status:
EC Labeling: Not applicable.
International Chemical Inventory Lists:
None noted.

NOTE: Not meant to be all-inclusive.
SECTION 16 : ADDITIONAL INFORMATION
MSDS Revision Date:
December 22, 2000
Supersedes: March 6, 1992

December 22, 2000: New MSDS for Choletec Kit was developed by Bracco Diagnostics, Inc.
March 6, 1992: Bristol-Myers Squibb MSDS for CHOLETEC Kit.
MSDS Author:
The author of this Material Safety Data Sheet (MSDS) is Bracco Diagnostics Inc. This MSDS is generated and/or distributed by the Bristol-Myers Squibb Company on behalf of Bracco Diagnostics Inc. Please carefully review all of the information disclosed in this MSDS prior to handling or using the product referenced above.
Disclaimer:
The information contained in this MSDS was obtained by Bracco Diagnostics from sources believed to be accurate and reliable and represents information currently on file and known by Bracco. However, Bracco makes no representation, guaranty or warranty, express or implied, with respect to any such information, and specifically disclaims and assumes no liability resulting from the use, misuse or mishandling of either the product or this MSDS.

When sterile, pyrogen-free, sodium pertechnetate Tc 99m injection (a radioactive material) is added to the CHOLETEC Kit vial, the diagnostic agent Technetium Tc 99m mebrofenin is formed. The resulting material is radioactive.

When transporting an employee for medical assistance, after the employee has had direct contact with a radioactive material, care should be taken to avoid contamination of transport vehicle and medical facility. Skin decontamination and monitoring should be conducted as appropriate.

If ingestion of the prepared kit, containing radioactive Technetium Tc 99m, inadvertently occurs, the individual may be treated by water hydration or diuresis to facilitate elimination of the radioactive material.

Radioactive materials may pose significant health risks if not properly handled. Personnel who handle radioactive materials should be trained in their use and should follow appropriate precautions for work with these materials.

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.2 mm of lead (Pb).

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides) and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Dispose of radioactive material in accordance with all local, state, federal and NRC regulations or with the regulations of the country in which the material is used.

Diagnostic agents are intended for use under direction of a physician and under the conditions of use described on the label and the product''s package insert. As a general precaution, personnel who handle these products should avoid contact (ingestion, inhalation, skin and eye contact) with them.

This material safety data sheet is intended for use by personnel who handle this material as part of their job responsibilities and it does not address the diagnostic use of this material. Information concerning the use of this diagnostic agent should be obtained from the product package insert and other appropriate references.


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