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MSDS Material Safety Data Sheet
CAS

122795-43-1
7732-18-5
12260-91-2

File Name: amershamhealth-us_com---omniscan.asp
GE Healthcare



OMNISCAN鈩?
(Gadodiamide) Injection


MATERIAL SAFETY DATA SHEET
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION


Product Name: OMNISCAN鈩?

Synonyms: WIN 50678 Injection

Manufacturer/Distributor: GE Healthcare, Inc.
101 Carnegie Center
Princeton, NJ 08540-9998

Technical Information No.: (800) 654-0118

CHEMTREC Emergency No.: (800) 424-9300 for US / (708) 527-3887 outside US


2. COMPOSITION/INFORMATION ON INGREDIENTS


Ingredient : CAS No. %V
Gadodiamide 122795-43-1 >25
Water 7732-18-5 >25
Caldiamide Sodium 12260-91-2 <5


3. HAZARD IDENTIFICATION


OMNISCAN鈩? is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI)
indicated for intravenous use to:

鈥? Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues.
鈥? Facilitate the visualization of lesions with abnormal vacularity within the thoracic, abdominal,
pelvic cavities, and the retroperitoneal space.

Warning: This is a pharmaceutical material available only with a prescription 鈥? use as directed.




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Physical & Chemical Hazard Ratings (0 = no hazard)

NFPA: Health 0 Flammability 0 Stability 0
HMIS: Health 0 Flammability 0 Stability 0

Transportation Symbol: None

Emergency Overview: Read package insert prior to use. As part of good laboratory practice, personal
hygiene and safety procedure, avoid unnecessary exposure to this substance. If exposure occurs, flush
the affected area with soap and water.

Potential Health Effects: Not expected to be a health hazard via routes of entry into the body
(inhalation, Ingestion, absorption or injection). No adverse effects expected upon skin or eye contact.
No adverse effects expected as a result of chronic exposure.


4. FIRST AID MEASURES

Eyes: In case of eye contact, immediately flush eyes with water for at least 15 minutes. Call a
physician if irritation develops.

Skin: Wash exposed area with soap and water. Call a physician if irritation develops.

Ingestion: No adverse effects expected. Call a physician if cramping or nausea develops.

Inhalation: No adverse effects expected, which would require first aid or other medical assistance.

Note to Physician: Treat symptomatically


5. FIRE FIGHTING MEASURES
FIRE FIG


Flammable Properties: Not flammable

Extinguishing Media: Use extinguishing measures that are appropriate to local circumstances and the
surrounding environment.

Hazardous Combustion products: Carbon oxides

Explosion Data: None

Protective Equipment and Precautions for Firefighters: As in any fire, wear self-contained breathing
apparatus pressure-demand. MSHA/NIOSH (approved or equivalent) and full protective gear.

6. ACCIDENT RELEASE MEASURES


SPILLS:



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Since the quantity per vial is small (ml), spills can be absorbed with an inert material and discarded.

Wash the affected area with soap and water.

Ensure compliance with local, state and federal regulations.


7. HANDLING AND STORAGE


Handling: Always observe good laboratory and hygiene pratices when handling. Avoid direct contact
with the material. Wear appropriate protective clothing and impervious gloves.

Storage: Store at controlled room temperature at 20 - 25潞 C. Do not freeze or expose to heat.


8. EXPOSURE CONTROLS/PERSONAL PROTECTION


Exposure Limits: This product is considered not to be hazardous and has no occupational exposure
limits (e.g. PEL, TLV, IDLH, etc.) established for it.

Engineering Measures: Eyewash station and good general room ventilation

Eye/Face Protection: Avoid contact with eyes & face use eye protection

Skin & Body Protection: Avoid contact with skin cover exposed skin

Respiratory Protection: Not required

Hygiene Measures: When using, do not eat, drink or smoke. Remove and wash contaminated clothing
before re-use.


9. PHYSICAL AND CHEMICAL PROPERTIES


Physical State: Liquid solution Autoignition Temperature: None

Appearance: Clear to pale yellow Flammable Limits: None

Odor: Odorless Boiling Point: No data available

Solubility: Soluble in water Melting Point: None

Specific Gravity: 1.15 Vapor Pressure (mm Hg): No data available

Viscosity: 2.0 (@ 20鈦癈) Evaporation Rate: No data available

pH: 5.5 鈥? 7.0 Vapor Density: No data available

Flash Point: None


Page 3 of 5
10. STABILITY AND REACTIVITY


Stability: Stable under specified conditions of use and storage.

Conditions to Avoid: None known

Incompatible Products: None known

Hazardous Decomposition Products: None known

Hazardous Polymerization: Will not occur.

11. TOXICOLOGICAL INFORMATION


Acute Toxicity: Product does not present an acute toxicity hazard. Oral LD鈧呪個 = 19.7 g/kg (mice)

Carcinogenicity: No known carcinogenic effects.

Reproductive Toxicity: No known adverse reproductive effects.

Target Organ Effects: No known adverse effects to the eyes or skin.

Endocrine Disruptor Information: Does not contain known or suspected edocrine disruptors.

12. ECOLOGICAL INFORMATION


Ecotoxicity: Contains no substances known to be hazardous to the environment or that are not
degradable in waste water treatment plants

13. DISPOSAL CONSIDERATIONS

If medical waste is involved, such as blood, blood products and/or sharps (needle/syringes, glass, etc.),
the waste must be handled as a biohazard and disposed of accordingly. If not a biohazard, waste
OMNISCAN鈩? is considered non-hazardous. Consult local, state and federal regulations for proper
disposal.

14. TRANSPORT INFORMATION

DOT: Not regulated IATA: Not regulated

TDG: Not regulated IMDG/IMO: Not regulated

MEX: Not regulated RID: Not regulated

ICAO: Not regulated ADR: Not regulated


Page 4 of 5
15. REGULATORY INFORMATION


OSHA Hazard Communication: This product is not considered hazardous under the OSHA Hazard
Communcation Standard (29 CFR 1910.1200) guidelines.

CERCLA Reportable Quantites: Not regulated

SARA Title III: Not regulated

CWA: Not regulated

RCRA hazrdous Waste Status: Non-hazardous (See Section 12 for details)

California Proposition 65: Not regulated

Mexico: Minimum risk, Grade = 0

Canada: WHMIS Hazard Class = Non-controlled


16. OTHER INFORMATION

Issue Date: 31-Aug-07

Revision Date: 31-Aug-07

Disclaimer:

This information is furnished without warranty, representation, or license of any kind, except that it is accurate to the best of
GE Healthcare鈥檚 knowledge or obtained from sources believed to be accurate. GE Healthcare does not assume any legal
responsibility for use or reliance upon same. Customers are encouraged to conduct their own evaluation. Before using any
product, read the product insert and label. OMNISCAN is a trademark of GE Healthcare. GE and GE Monogram are
trademarks of the General Electric Company.

End of MSDS




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