Nu-Medopa

MATERIAL SAFETY DATA SHEET

 
Date Prepared:  02/20/2003 
MYCAMINE (MICAFUNGIN SODIUM) FOR INJECTION
Date Reviewed:  02/20/2003 

1.    CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

       Product Identifier:  Micafungin
       General Use:  Antifungal
 

     MANUFACTURED FOR EMERGENCY TELEPHONE NUMBER 
     Astellas Pharma US, Inc.(800) 727-7003 
     3 Parkway North 
     Deerfield, IL 60015-2538
     (847) 317-8800 

2.    COMPOSITION/INFORMATION ON INGREDIENTS
      Component: Citric AcidCAS Registry #:77-92-9
UN Number: 
     OSHA PEL:NEmg/m3      OSHA PEL:NEppm
      ACGIH TLV:NEmg/m3      ACGIH TLV:NEppm
      STEL:NEmg/m3      STEL:NEppm
     Percent of Product:NGNote:   NG

 

      Component: LactoseCAS Registry #:63-42-3
UN Number:NG
     OSHA PEL:NEmg/m3      OSHA PEL:NEppm
      ACGIH TLV:NEmg/m3      ACGIH TLV:NEppm
      STEL:NEmg/m3      STEL:NEppm
     Percent of Product:NGNote:   NG

 

      Component: Micafungin SodiumCAS Registry #:208538-73-2
UN Number:NG
      Chemical Name: (-) - Sodium 5-[1S, 2S) - 2 - [( 3S, 6S, 9S, 11R, 15S, 18S, 20R, 21R, 24S, 25S, 26S,) -18 -3- [(R) - 2 - carbamoyl- 1 - hydroxyethyl] - 11, 20, 21, 25 - tetrahydroxy - 15 - [(R)-1- hydroxyethyl] - 26-methyl- 2,5,8,14,17,23 - hexaoxo - 18- [4 -[5-(4-pentyloxyphenyl) isoxazol - 3 - yl] benzoylamino] -1,4,7,13,16,22, - hexaazatricyclo [ 22.3.0.0 9,13] heptacos-6-yl] - 1,2-dihydroxyethyl]-2- hydroxyphenyl sulfate
     OSHA PEL:NEmg/m3      OSHA PEL:NEppm
      ACGIH TLV:NEmg/m3      ACGIH TLV:NEppm
      STEL:NEmg/m3      STEL:NEppm
     Percent of Product:NGNote:   50mg

 

      Component: Sodium HydroxideCAS Registry #:1310-73-2
UN Number:NG
     OSHA PEL:2mg/m3      OSHA PEL:NEppm
      ACGIH TLV:2mg/m3      ACGIH TLV:NEppm
      STEL:2mg/m3      STEL:NEppm
     Percent of Product:NGNote:   NG


3.    HAZARD IDENTIFICATION
       PRIMARY ROUTES OF EXPOSURE - Inhalation, Eye/Skin Absorption and Ingestion.


 

COMPONENTCAS No.
 NTP 
 IARC 
 OSHA 
COMMENT
Citric Acid77-92-9NO
NO
NO
NA
Lactose63-42-3No Data
No Data
No Data
NA
Micafungin Sodium208538-73-2No Data
No Data
No Data
 
Sodium Hydroxide1310-73-2No Data
No Data
No Data
Sodium hydroxide is considered an eye irritant.

4.    EMERGENCY AND FIRST AID PROCEDURES

Inhalation: Move person to fresh air immediately. Give artificial respiration and Cardiopulmonary Resuscitation (CPR) if required. Seek medical attention.

Ingestion: Flush mouth out with woater immediately. Seek medical attention.

Skin Contact: Remove contaminated clothing immediately. Flush area with water for at least 15 minutes. Seek medical attention.

Eye Contact: Immediately flush with water for at least 15 minutes. If irritation persists, seek medical attention.

For Adverse Drug Reaction Information: phone: (847) 317-1276; fax: (847)-317-1241; email:[email protected]


5.    FIRE FIGHTING MEASURES
       Fire and Explosion Data:
 
      Product Flammability:Non-Flammable      Closed Cup Flash Pt.:NA
      Autoignition:NA      Open Cup Flash Pt.:NA
      Flammability Limits:NA
 
      Products of Combustion:NA
      Fire Hazards in the Presence of Various Subtances:None
      Explosion Hazards in the Presense of Various Substances:- Risk of explosion of the product in presence of mechanical impact: NA - Risk of explosion of the product in presence of static discharge: NA
      Firefighting Media and Instructions:NG
      Firefighting Equipment:Water
      Protective Clothing (fire):USe extinguishing media suitable for surrounding materials
      Special Remarks on Fire Hazards:None


6.    ACCIDENTAL RELEASE MEASURES

Clean up: Wear recommended personal protective equipment. Use absorbent towels or booms to clean up spills. Wipe surfaces clean and wash with soap and water.


7.    HANDLING AND STORAGE

When handling pharmaceutical products, avoid all contact and inhalation of dust, fumes, mist,and/or vapors associated with the product.
Store product at room temperature 20 to 25C(68-77 F)


8.    EXPOSURE CONTROLS/PERSONAL PROTECTION

ENGINEERING CONTROLS:
Under indicated use, general room ventilation is usually satisfactory. Use local exhaust ventilation when necessary.

PERSONAL PROTECTION:
Respirators: With satisfactory ventilation, repiratory protection not usually required.
Eyes: Safety glasses or goggles recommended.
Gloves: Disposable latex (or other appropriate) gloves
Clothing: Disposable garments if direct skin contact is anticipated.


9.    PHYSICAL AND CHEMICAL PROPERTIES
       Appearance, other characteristics:  Lyophilized powder
 
      Boiling Point:NAVapor Density:NA
      Melting Point:No clean pointPercent Volatiles:NA
      Freezing Point:NGpH:5-6
      Vapor Pressure:NAMolecular Weight:1292.27
      Note:NoneSolubility:More than 200mg/mL
      Color:White to yellowishOdor:None noted
      Specific Gravity:NGLogK:NE


10.   STABILITY AND REACTIVITY
      Stability:Stable
      Conditions/Materials to Avoid:None
      Hazardous Polymerization:Will not occur



11.    TOXICOLOGY INFORMATION
 
INGREDIENT NAMETEST
 RESULT 
 ROUTE 
 SPECIES 
Micafungin SodiumLD50125mg/kg
IV
Male rats
Micafungin SodiumLD50250mg/kg
IV
Female rats
Micafungin SodiumLD50>200mg/kg
IV
Male and Female dogs

SIGNS & SYMPTOMS OF OVEREXPOSURE MAY INCLUDE:
This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert, these may include:nausea, headache, diarrhea, pruritits and bilirubinemia. Occupational exposure has not been fully investigated.

MEDICAL CONDITIONS GENERALLY RECOGNIZED AS BEING AGGRAVATED BY EXPOSURE:
Pre-existing skin and respiratory conditions.

IMMEDIATE EFFECTS: Eye, skin and repiratory irritation may occur.


12.    ECOLOGICAL INFORMATION
 
INGREDIENT NAMESPECIES
 PERIOD 
 RESULT 
** Not Available **

      BOD and COD:NA
      Biodegradable/OECD:Not available
      Mobility:Not available
      Products of Degradation:The product itself and its products of degradation are not toxic
      Toxicity of the Products of Biodegradation:Not available
      Special Remarks on the Products of Biodegradation:Not available


13.    WASTE DISPOSAL

Waste Disposal: Waste product should be incinerated in accordance with all federal, state and local regulations


14.    TRANSPORT INFORMATION
 
REGULATORY INFORMATIONUN NumberProper ShippingClass
United States (DOT)Not regulated  
   PACKING GROUP:  LABEL:  
   ADDITIONAL INFORMATION:  
Canada (TDG)Not regulated  
   PACKING GROUP:  LABEL:  
   ADDITIONAL INFORMATION:  
Mexico (NOM-004-SCT2-1994)Not regulated  
   PACKING GROUP:  LABEL:  
   ADDITIONAL INFORMATION:  

      NAERG:NA


15.    REGULATORY INFORMATION
 
      HCS Classification:Not controlled under HCS (US)
      U.S. Federal Regulations:TSCA 8(b) inventory: All components listed Clean Water Act (CWA) 307: No products were found Clean Water Act (CWA) 311: Sodium Hydroxide Clean Air Act (CAA)112 accidential release prevention: No products were found Clean Air Act (CAA) 112 flammable substances: No products were found Clean Air Act (CAA) 112 toxic substances: No products were found SARA 302/304/311/312 extremely hazardous substances- No products found SARA 302/304 emergency planning and notification: no products were found SARA 302/304/311/312 hazardous chemicals: No products were found SARA 311/312 MSDS distribution- chemical inventory-hazard identification: No products were found
     SARA 313:
       Form R - Reporting Requirements:No products were found
       Supplier Notification:No products were found
      State Regulations:Pennsylvania RTK: Sodium hydroxide: (environmental hazard, generic environmental hazard) Massachusetts RTK: Sodium hydroxide New Jersey: Sodium hydroxide California prop 65: No products were found
      WHMIS (Canada):Not controlled under WHMIS (Canada) CEPA DSL: All components listed
      Classification of the Degree of Risk (Mexico):No hazardous ingredient


16.    OTHER INFORMATION
 
National FireHazards   
ProtectionFire: 0
AssociationHealth: 1
(U.S.A)Reactivity: 0
Special:

 
      Label Requirements:Follow good industrial hygiene practice
      References:

      Abbreviations:
     ACGIH: American Conference Of Governmental Industrial Hygienists
     HEPA: High-Efficiency Particulate Air
     IARC: International Agency for Research on Cancer
     NA: Not Applicable
     NE: Not Established
     NG: Not Given
     NIOSH: National Institute for Occupational Safety and Health
     NTP: National Toxicology Program
     OSHA: Occupational Safety and Health Administration
     PEL: Permissable Exposure Limit
     PPM: Parts Per Million
     QS: Quantity Sufficient
     RCRA: Resource Conservation and Recovery Act
     STEL: Short Term Exposure Limit
     TLV: Threshold Limit Value