Material Safety Data Sheet...FUROSEMIDE INJECTION, USP, 10 mg/mL Material Safety Data Sheet MSDS No....

FUROSEMIDE INJECTION, USP, 10 mg/mL

Material Safety Data Sheet

MSDS No. CLI/MSDS/FUR.01

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Common/Trade Name: Furosemide Injection, USP

How Supplied: Strength: 10 mg/mL

Chemical Class Anthranilic acid derivative

Chemical Name Benzoic acid, 5-(aminosulfonyl)-4-chloro-2- [(2-furanylmethyl) amino]-. 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid

Formula C12H11ClN2O5S

Product Type Prescription Drug

Product Use Pharmaceutical, Injectable

Address CHACHARWADI-VASANA,

Distributor Name CLARIS LIFESCIENCES INC.

Distributor Address CHACHARWADI-VASANA, AHMEDABAD - 382 213, INDIA.

Manufacturer's Name CLARIS INJECTABLES LIMITED

1. PRODUCT IDENTIFICATION

thDate Prepared 04 , February 2015




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2. COMPOSITION INFORMATION

Component mg/mL CAS#

Furosemide 10.00 54-31-9

Sodium Chloride 7.50 7647-14-5

Sodium Hydroxide 1.34 1310-73-2

Sodium Hydroxide q.s. to pH 1310-73-2

Hydrochloric Acid q.s. to pH 7647-01-0

Water for Injection q.s. to 1mL 7732-18-5

q.s.- Quantity Sufficient

3. HAZARDOUS IDENTIFICATION

Emergency Overview: In clinical use, this material is used to promote urination. Possible target organs include the kidneys, fetus, DNA and ears. Likely Routes of exposure: Eye contact, inhalation and ingestion. Inhalation: May cause irritation of the upper and lower respiratory tract. . Contact with Skin or Eyes: Causes irritation of the eye. May cause irritation of the skin. Ingestion: May cause irritation of the gastrointestinal tract. Medical Conditions Aggravated by Exposure: Workers with impaired cardiovascular, kidney or liver functions should minimize their exposure to this product. It is strongly recommended that pregnant workers not be exposed to this product.

4. FIRST-AID MEASURES Skin Exposure: Remove contaminated clothing. Flush area with copious quantities of water for 15 minutes. Seek medical attention. Eye Exposure: Flush for 15 minutes with copious quantities of water. Seek medical attention. Inhalation: Remove person to fresh air. Remove contaminated clothing. Seek medical attention. Ingestion: Flush mouth out with water. Seek medical attention.




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NOTES TO HEALTH PROFESSIONALS: Exposure to this product may result in headache, tinnitus, electrolyte imbalance, dry mouth, weakness, lethargy, drowsiness and muscle pains. Dermatitis, urticaria, rash and photosensitivity could be observed. Tachycardia, arrhythmia, hypotension, hypocalemia, hypochloremic alkalosis, nausea and vomiting may be observed as well. See prescribing information. .

5. FIRE-FIGHTING MEASURES:

Flash Point: Nonflammable, noncombustible Auto ignition Temperature: Not applicable Flammable Limits (in air by volume, %): Lower: Not applicable Upper: Not applicable Fire Extinguishing Equipment: Water spray, foam, dry chemical or Carbon Dioxide (CO2). Fire Fighting Equipment: Wear self-contained breathing apparatus and protective clothing. Hazardous Combustion Products: When heated, Furosemide solution thermally decomposes to form toxic vapors. (I.e. Carbon Monoxide, Carbon Dioxide and Nitrogen Oxides)

6. ACCIDENTAL RELEASE INFORMATION

Spill Cleanup and Disposal: Absorb with suitable material and clean affected area with soap and water. Dispose of materials according to the applicable federal, state, or local regulations.

7. PRECAUTION FOR SAFE HANDLING AND USE

Handling: Protect from light by retaining in carton until contents have been used.

Storage: No special storage required for hazard control. For product protection store at controlled room temperature of 15-30°C (59-86°F). 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.

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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Ventilation and Engineering Controls: Use with adequate ventilation. Follow standard medical product handling procedures. Respiratory Protection: Under normal conditions of product use, respiratory protection is not required. When required, use a NIOSH approved air purifying respirator with combination P-100 / organic vapor cartridges. 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.

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.

. 8. EXPOSURE CONTROLS - PERSONAL PROTECTION


9. PHYSICAL AND CHEMICAL PROPERTIES

10. STABILITY AND REACTIVITY DATA

Specific Gravity: Approximate to water

Appearance: A clear, colorless to slightly yellow liquid

Melting Point/Range: Not applicable

Boiling Point/Range: Approximately 212 degrees Fahrenheit

Evaporation Rate: Not applicable

Vapor Pressure: Approximate to water

Solubility in Water: Aqueous solution

Vapor Density: Not Applicable

pH: Between 8.0 to 9.3

Physical State: Liquid




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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. Hazardous Polymerization: Will not occur.

Hazardous Combustion Products: Carbon Monoxide, Carbon Dioxide and Nitrogen Oxides may be released by thermal decomposition.

11. TOXICOLOGICAL INFORMATION

Oral (LD50) LD50: 2600 mg/kg oral - rat LD50: 4600 mg/kg oral - mouse LD50: 800 mg/kg oral - rabbit LD50: 1000 mg/kg oral – dog

Intravenous (LD50) LD50: 800 mg/kg intravenous - rat LD50: 308 mg/kg intravenous - mouse LD50: 400 mg/kg intravenous - rabbit LD50: 300 mg/kg intravenous – dog

Toxic Dose - Minimum (TDLo) TDLo : 29 mg/kg intravenous – human

Mutagenicity: Positive in the mouse lymphoma and chromosomal aberration assays. Sodium Chloride is considered mutagenic for mammalian somatic cells, bacteria and yeast.

Irritancy of Product: This product is expected to be irritating to eyes and skin. Sensitization to the Product: Repeated exposures may lead to sensitivity to this product.

12. ENVIRONMENTAL IMPACT INFORMATION

Environmental Stability: This product will be relatively stable under ambient environmental conditions. Bioaccumulation / Accumulation: No applicable bioaccumulation is expected in the environment.

Mobility in Environment: Appreciable volatilization is not expected into the air. Persistence / Degradability: Short-term products of biodegradation are not likely. Long-term degradation products may arise.

13. DISPOSAL INFORMATION

Do not mix with other substances. Dispose of in accordance with Federal, state and local regulations.




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14. TRANSPORTATION INFORMATION US DOT (ground): Not considered a DOT regulated material - Non hazardous for shipment. 15. REGULATORY INFORMATION TSCA Status Not Regulated

CERCLA Status Not Regulated SARA Status Not Regulated RCRA Status Not Regulated PROP 65 (Calif.) Not Regulated Notes: TSCA Toxic Substance Control Act

CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act SARA Superfund Amendments and Reauthorization Act RCRA US EPA, Resource Conservation and Recovery Act Prop 65, California Proposition 65

16. OTHER DATA

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.

Material Safety Data Sheet...FUROSEMIDE INJECTION, USP, 10 mg/mL Material Safety Data Sheet MSDS No....

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