Akorninc
MSDS: SUBLIMAZE
Ophthalmic and Parenteral Health Care
INJECTION 0.05mglmL
I
I Material Safety Data Sheet Manufacturer: Akom Inc. Telephone: (217) 428-11 00 150 S. Wyckles Road Decatur, IL 62522 Section 1- IDENTIFICATION TRADE NAME: Fentanyl Citrate Injection, 0.05 mg/mL (Sublimaze Injection, 0.05 mg/mL) ' Description: Analgesic (Narcotic) Composition CAS# TLV(mg/m3 ) %Content Fentanyl Citrate 990-73-8 NE NE 99% Common name of active ingredients: Fentanyl Citrate Chemical Formula (s): C22H2sN20.C~s07 NE= Not established Section 2- HAZARDOUS INGREDIENTS
******************************************************* EMERGENCY OVERVIEW DANGER! POTENT NARCOTIC ************************************************************ Principal Hazardous Ingredients: Fentanyl Citrate %Threshold Limit Value: NE Carcinogenicity: NE NTP-No IARC-None OSHA-NE NE= Not established Section 3- PHYSICAL AND CHEMICAL CHARACTERISTICS Boiling Point (C 0 ): NE Vapor Pressure (mm Hg): NE Solubility in Water: 27g/L at 20°C (pH 3.8) Specific Gravity: NE V olatilc: NE Evaporation Rate: NE Reactivity in Water: NE
Vapor Density: NE Viscosity: NE
1 Obtained by Global Safety Management, Inc. www.globalsafetynet.com
Akorn;nc
I
MSDS: SUBLIMAZE
Ophthalmic and Parenteral Health Care
INJECTION 0.05mg/mL
Appearance: Clear, colorless solution Odor: Odorless NE= Not established Section 4- FIRE AND EXPLOSION HAZARD DATA Extinguisher Media: Water spray, dry chemical, alcohol foam, or carbon dioxide. Auto Ignition Temperature: NE Method: NE Special Firefighting Procedures: Wear self-contained breathing apparatus and protective clothing. Use water spray to keep fire-exposed containers cool.
Special Information: In the event of a fire, wear full protective clothing and NIOSHapproved self-contained breathing apparatus with full-face piece operated in the pressure demand or other positive pressure mode.
CONDTIONS TO AVOID Incompatibility: No information found. Hazardous Decomposition Products: Burning may produce carbon monoxide, carbon dioxide, and nitrogen oxides.
Hazardous Polymerization: Will not occur. Conditions to Avoid: No information found. NE= Not Established Section 5- REACTIVITY DATA NA Section 6- HEALTH HAZARDS Threshold Limit Value: NE Signs and Symptoms of Exposure: 1. Oral: Nausea, vomiting, constipation, fatigue, irritability, sedation, restlessness, dizziness, felling of weakness, palpitations, slow heart beat, respiratory difficulties, poor circulation, lowering of blood pressure, coma, respiratory and cardiac arrest followed by death. 2. Eyes: Not known 3. Skin: Not known 4. Inhalation: Nausea, vomiting, constipation, fatigue, irritability, sedation, restlessness, dizziness, felling of weakness, palpitations, slow heart beat, respiratory difficulties, poor circulation, lowering of blood pressure, coma, respiratory and cardiac arrest fullowed by Jcath.
NE= Not established
2 Obtained by Global Safety Management, Inc. www.globalsafetynet.com
Akorninc Ophthalmic and Parenteral Health Care
MSDS: SUBLIMAZE INJECTION 0.05mglmL
Chemical Listed as Carcinogen or Potential Carcinogen: No X National Toxicology Program: Yes I.A.R.C Monographs: Yes No____x_____ OSHA: NE OSHA Permissible Exposure Limit: NE ACGIH Threshold Limit Value: NE Other Exposure Limit Used: NE NE= Not established Emergency and First Aid Procedures: 1. Inhalation: Narcotic. Can irritate the respiratory passages and cause sneezing or coughing but will also have an anesthetic effect. Inhalation of appreciable quantities may produce lung edema, dizziness, and respiratory difficulties; large dose inhalation may result in respiratory arrest. a. First Aid Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. 2. Eyes: Mild irritant but will also have a strong narcotic effect (pupil constriction) and the eye may serve as an absorption rout to the body in general. a. First Aid Eyes: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately. 3. Skin: Absorption through skin may occur. Symptoms may parallel ingestion. a. First Aid Skin: Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Call a physician, immediately. Wash clothing before reuse. 4. Ingestion: Toxic! Narcotic. Minimum Lethal Dosage: Fentanyl250 ug. In addition to its analgesic action, may cause gastric disturbance with nausea, vomiting and constipation. Large amounts may cause central nervous system depression, respiratory or cardiac collapse, coma, and death. a. First Aid Ingestion: Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person. Note to physicians: The principal sign of serious overdose to fentanyl include stupor and respiratory depression. Treatment for these effects due to fentanyl is the same as for overdose by other opiods: airway maintenance, ventilation support, and administration of a narcotic antagonist. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.
3 Obtained by Global Safety Management, Inc. www.globalsafetynet.com
I I
Akorninc
I
MSDS: SUBLIMAZE
Ophthalmk and Parenteral Health Care
INJECTION 0.05mglmL
Section 7- SPECIAL PRECAUTIONS AND SPILL/LEAK PROCEDURES Steps to be taken in case material is released or spilled: Ventilate area ofleak or spill. Remove all sources of ignition. Isolate hazard area. Keep unnecessary and unprotected personnel from entering. More than one individual should witness all clean-up operations. Spills: Carefully sweep up material into an appropriate container and save for disposal. Use non-sparking tools and equipment. Do not flush to sewer! The amount of material collected should be assessed and documented. Waste Disposal Methods: Notify site Drug Enforcement Agency compliance officer and local DEA office for appropriate disposal procedures. Processing, use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. Section 8- PROTECTION INFORMATION Airborne Exposure Limits: Fentanyl: Occupational Exposure Guidelines (OEG): 0.7ug/m3, as 8 hour time-weighted average Short-term Exposure Guidelines (STEG): 2ug/m3, as IS-minute average, Notation: Skin Ventilation System: Recommended. Skin Protection: Wear appropriate gloves. Eye Protection: Use chemical safety goggles. Maintain eye wash fountain and quickdrench facilities in work area. Section 9- TOXICOLOGY INFORMATION Information is for pure Fentanyl Citrate. Oral, rat: LDso = 18 mg/kg Oral, mouse: LDso = 100 mg/kg
Section 10- ECOLOGICAL INFORMATION
Chemical fate information: NE Other Precautions: NE NE= Not established
4 Obtained by Global Safety Management, Inc. www.globalsafetynet.com
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Akorn;nc Ophthalmic and Parenteral Health Care
MSDS: SUBLIMAZE INJECTION 0.05mglmL
The information given herein is in good faith and to the best of our knowledge but no warranty expressed or implied is made Date:
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5 Obtained by Global Safety Management, Inc. www.globalsafetynet.com
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