Methyldopate HCL
 |
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 Acid | CAS Registry #: | 77-92-9 |
| UN Number: |
| OSHA PEL: | NE | mg/m3 | OSHA PEL: | NE | ppm |
| ACGIH TLV: | NE | mg/m3 | ACGIH TLV: | NE | ppm |
| STEL: | NE | mg/m3 | STEL: | NE | ppm |
| Percent of Product: | NG | Note: | NG |
Inhalation: Move person to fresh air immediately. Give artificial respiration and Cardiopulmonary Resuscitation (CPR) if required. Seek medical attention. 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. When handling pharmaceutical products, avoid all contact and inhalation of dust, fumes, mist,and/or vapors associated with the product. ENGINEERING CONTROLS: SIGNS & SYMPTOMS OF OVEREXPOSURE MAY INCLUDE: Waste Disposal: Waste product should be incinerated in accordance with all federal, state and local regulations Component: Lactose CAS Registry #: 63-42-3 UN Number: NG OSHA PEL: NE mg/m3 OSHA PEL: NE ppm ACGIH TLV: NE mg/m3 ACGIH TLV: NE ppm STEL: NE mg/m3 STEL: NE ppm Percent of Product: NG Note: NG Component: Micafungin Sodium CAS 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: NE mg/m3 OSHA PEL: NE ppm ACGIH TLV: NE mg/m3 ACGIH TLV: NE ppm STEL: NE mg/m3 STEL: NE ppm Percent of Product: NG Note: 50mg Component: Sodium Hydroxide CAS Registry #: 1310-73-2 UN Number: NG OSHA PEL: 2 mg/m3 OSHA PEL: NE ppm ACGIH TLV: 2 mg/m3 ACGIH TLV: NE ppm STEL: 2 mg/m3 STEL: NE ppm Percent of Product: NG Note: NG
3. HAZARD IDENTIFICATION
PRIMARY ROUTES OF EXPOSURE - Inhalation, Eye/Skin Absorption and Ingestion.
COMPONENT CAS No. COMMENT Citric Acid 77-92-9 NO NA Lactose 63-42-3 No Data NA Micafungin Sodium 208538-73-2 No Data Sodium Hydroxide 1310-73-2 No Data Sodium hydroxide is considered an eye irritant.
4. EMERGENCY AND FIRST AID PROCEDURES
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
7. HANDLING AND STORAGE
Store product at room temperature 20 to 25C(68-77 F)
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
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: NA Vapor Density: NA Melting Point: No clean point Percent Volatiles: NA Freezing Point: NG pH: 5-6 Vapor Pressure: NA Molecular Weight: 1292.27 Note: None Solubility: More than 200mg/mL Color: White to yellowish Odor: None noted Specific Gravity: NG LogK: NE
10. STABILITY AND REACTIVITY Stability: Stable Conditions/Materials to Avoid: None Hazardous Polymerization: Will not occur
11. TOXICOLOGY INFORMATION
INGREDIENT NAME TEST Micafungin Sodium LD50 125mg/kg Micafungin Sodium LD50 250mg/kg Micafungin Sodium LD50 >200mg/kg
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 NAME SPECIES ** 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
14. TRANSPORT INFORMATION
REGULATORY INFORMATION UN Number Proper Shipping Class 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 Fire 
Hazards Protection Fire: 0 Association Health: 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