MATERIAL SAFETY DATA SHEET

Copy and paste this link to your website, so they can see this document directly without any plugins.


Keywords

Listed, CERCLA/SARA, Proposition, reporting, Emission, section, California, Cefpodoxime, Proxetil, Oral, NOAEL, Tablets, mg/kg/day, Material, date:, 01-Nov-2004, MATERIAL, SAFETY, Safety, Revision, mg/kg, Name:, DATA, List:, SHEET, Version:, Proxetil), (Cefpodoxime, Simplicef, Fertility

Transcript

Page 1 of 6 Revision date: 01-Nov-2004
MATERIAL SAFETY DATA SHEET
Version: 1.0
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: Simplicef (Cefpodoxime Proxetil) Tablets - 100 and 200 mg
Synonyms: Cefpodoxime Proxetil Tablets
Intended Use: Veterinary antibiotic agent
2. COMPOSITION/INFORMATION ON INGREDIENTS
Ingredient CAS Number EU EINECS List: Classification %
Cefpodoxime Proxetil 87239-81-4 Not Listed Not Listed 30.3
Carboxy methylcellulose calcium 9050-04-8 Not Listed Not Listed 17.9
Water 7732-18-5 231-791-2; H2O Not Listed 42.5
SD Alcohol 3A Not assigned Not Listed Not Listed 6
Hydroxypropyl cellulose 9004-64-2 Not Listed Not Listed 1.5
Sodium Lauryl Sulfate 151-21-3 Not Listed Not Listed <1.0
Magnesium Stearate 557-04-0 209-150-3;
C18H36O2.1/2Mg
231-104-6; Mg
Not Listed <1.0
Lactose Monohydrate 64044-51-5 Not Listed Not Listed <1.0
3. HAZARDS IDENTIFICATION
Appearance: Orange tablets
Signal Word: WARNING
Statement of Known Hazard
(GHS Classification):
May cause allergic reaction
Potential Health Effects: Individuals who are sensitive to beta lactam antibiotics, both penicillins and cephalosporins,
may experience contact or systemic hypersensitivity and anaphylaxis upon exposure to this
drug.
Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhoea.
Pseudomembranous colitis (manifested by watery diarrhea, urge to defecate, abdominal
cramps, low-grade fever, bloody stools, and abdominal pain) may also occur.
Potential Environmental
Effects:
Not determined
Potential Physical / Chemical
Hazards:
Not determined
EU Indication of danger: Xn - Harmful
Telephone: 01304 616161
(Pfizer Ltd Main Exchange)
Pfizer Inc
Pfizer Pharmaceuticals Group
235 E 42nd Street
New York, New York 10017
Pfizer Ltd,
Kent
CT13 9NJ
United Kingdom
Emergency telephone number: 1-212-573-2222
Hours of Operation - 24 Hours
Emergency telephone number: 1-212-573-2222
Hours of Operation - 24 Hours
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
Material Name: Simplicef (Cefpodoxime Proxetil) Tablets - 100
and 200 mg
Revision date: 01-Nov-2004
Page 2 of 6
Version: 1.0
R42/43 - May cause sensitization by inhalation and skin contact.
Note: This document has been prepared in accordance with standards for workplace safety, which
requires the inclusion of all known hazards of the product or its ingredients regardless of the
potential risk. The precautionary statements and warning included may not apply in all cases.
Your needs may vary depending upon the potential for exposure in your workplace.
4. FIRST AID MEASURES
Eye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.
Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek
medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not
induce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.
Notes to Physician: None
Medical Conditions Aggravated by
Exposure:
None known
5. FIRE FIGHTING MEASURES
Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.
Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire.
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
6. ACCIDENTAL RELEASE MEASURES
Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (see
Section 8). Minimize exposure.
Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spilled material by a method that
controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of
dry solids. Clean spill area thoroughly.
Measures for Environmental
Protections:
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to
avoid environmental release.
Additional Consideration for Large
Spills:
Non-essential personnel should be evacuated from affected area. Report emergency
situations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
Material Name: Simplicef (Cefpodoxime Proxetil) Tablets - 100
and 200 mg
Revision date: 01-Nov-2004
Page 3 of 6
Version: 1.0
General Handling: Ground and bond all bulk transfer equipment. Avoid open handling. Minimize dust generation.
Use local exhaust ventilation or perform work under hood/fume cupboard. Avoid inhalation and
contact with skin, eyes, and clothing. When handling, use appropriate personal protective
equipment (see Section 8).
Storage Conditions: Store at room temperature in properly labeled containers. Keep away from heat, sparks and
flames.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Pfizer OEL: 0.1 mg/m3 (Cefpodoxime)
Laboratory Scale:
Engineering Controls: Engineering controls should be used as a primary means of containment. Perform operations
in a ventilated enclosure.
Personal Protective
Equipment:
Wear safety glasses, protective gloves and a laboratory coat when handling this compound.
Pilot Plant Scale:
Engineering Controls: Engineering controls should be used as a primary means of containment. Handle in enclosed
systems or under suitable local exhaust systems.
Personal Protective
Equipment:
Wear safety glasses, protective gloves, coveralls, and protective boots when handling this
compound. Evaluate additional respiratory protection, as needed based on available
engineering controls.
Manufacturing Scale:
Engineering Controls: Engineering controls should be used as a primary means of containment. Handle in enclosed
systems or under suitable local exhaust systems.
Personal Protective
Equipment:
Wear safety glasses, protective gloves, coveralls, and protective boots when handling this
compound. Evaluate additional respiratory protection, as needed based on available
engineering controls.
9. PHYSICAL AND CHEMICAL PROPERTIES:
Additional Information: The characteristics of this compound have not been fully determined.
10. STABILITY AND REACTIVITY
Stability: Stable at normal conditions
Conditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions.
Materials to Avoid: As a precautionary measure, keep away from strong oxidizers.
Polymerization: Will not occur
11. TOXICOLOGICAL INFORMATION
General Information: The following information is available for the individual ingredients.
Color: Orange
Molecular Formula: No data available. Molecular Weight: No data available.
Physical State: Tablets
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
Material Name: Simplicef (Cefpodoxime Proxetil) Tablets - 100
and 200 mg
Revision date: 01-Nov-2004
Page 4 of 6
Version: 1.0
Acute Toxicity
Irritation / Sensitization
Reproduction & Developmental Toxicity
Genetic Toxicity
12. ECOLOGICAL INFORMATION
Environmental Overview: Environmental properties have not been thoroughly investigated.
13. DISPOSAL CONSIDERATIONS
Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations.
14. TRANSPORT INFORMATION
The following refers to all categories of classifications unless specified below.
This material is not regulated for transportation / carriage.
In Vivo Micronucleus Negative
Eye Irritation Rabbit Positive Minimal
Rat Intravenous LD 50 >4000 mg/kg
Skin Irritation Rabbit Negative No effect
Magnesium Stearate
Mouse Oral LD 50 >8000 mg/kg
Cefpodoxime Proxetil
Reproductive & Fertility Rat Oral >500 mg/kg/day NOAEL Fertility
Rat Oral LD 50 1092 gm/kg/13 weeks
Reproductive & Fertility Rabbit Oral >500 mg/kg/day NOAEL Fertility
Embryo/Fetal Development Rat Oral 100 mg/kg/day NOAEL Not Teratogenic, Fetotoxicity
Lactose Monohydrate
Mouse Intraperitoneal LD 50 2535 mg/kg
Embryo/Fetal Development Rabbit Oral 30 mg/kg/day NOAEL Not Teratogenic, Fetotoxicity
Rat Oral LD 50 29700 mg/kg
Cefpodoxime Proxetil
Mouse Subcutaneous LD 50 >10,000 mg/kg
Bacterial Mutagenicity (Ames) Salmonella Negative
Cefpodoxime Proxetil
Chromosome Aberration Negative
Cefpodoxime Proxetil
Unscheduled DNA Synthesis Negative
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
Material Name: Simplicef (Cefpodoxime Proxetil) Tablets - 100
and 200 mg
Revision date: 01-Nov-2004
Page 5 of 6
Version: 1.0
15. REGULATORY INFORMATION
EU Labeling:
EU Indication of danger: Xn - Harmful
EU Risk Phrases:
R42/43 - May cause sensitization by inhalation and skin contact.
EU Safety Phrases:
S22 - Do not breathe dust.
S24 - Avoid contact with skin.
S37 - Wear suitable gloves.
EU EINECS List: Not Listed
EU ELINCS List: Not Listed
Not Listed
Cefpodoxime Proxetil
SD Alcohol 3A
CERCLA/SARA section 302 EHS TPQ Not Listed
Carboxy methylcellulose calcium
CERCLA/SARA 313 Emission reporting Not Listed
California Proposition 65 Not Listed
CERCLA/SARA section 302 EHS TPQ Not Listed
Hydroxypropyl cellulose
CERCLA/SARA section 302 EHS TPQ
CERCLA/SARA section 302 EHS TPQ Not Listed
Not Listed
CERCLA/SARA 313 Emission reporting Not Listed
CERCLA/SARA 313 Emission reporting Not Listed
California Proposition 65 Not Listed
Sodium Lauryl Sulfate
California Proposition 65
CERCLA/SARA section 302 EHS TPQ Not Listed
Not Listed
CERCLA/SARA 313 Emission reporting Not Listed
California Proposition 65 Not Listed
Water
CERCLA/SARA 313 Emission reporting
Magnesium Stearate
Not Listed
CERCLA/SARA section 302 EHS TPQ Not Listed
CERCLA/SARA section 302 EHS TPQ Not Listed
CERCLA/SARA 313 Emission reporting Not Listed
California Proposition 65 Not Listed
Lactose Monohydrate
CERCLA/SARA 313 Emission reporting Not Listed
CERCLA/SARA section 302 EHS TPQ Not Listed
California Proposition 65
California Proposition 65 Not Listed
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
Material Name: Simplicef (Cefpodoxime Proxetil) Tablets - 100
and 200 mg
Revision date: 01-Nov-2004
Page 6 of 6
Version: 1.0
CERCLA Reportable Quantity: Not determined
OSHA Label:
WARNING
May cause allergic reaction
Canada - WHMIS: Classifications
WHMIS hazard class:
D2a very toxic materials
D2b toxic materials
16. OTHER INFORMATION
Prepared by: Corporate Occupational Toxicology & Hazard Assessment
Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it
is without warranty of any kind, expressed or implied.
End of Safety Data Sheet
California Proposition 65 Not Listed
CERCLA/SARA 313 Emission reporting Not Listed

PDF Document reader online

This website is focused on providing document in readable format, online without need to install any type of software on your computer. If you are using thin client, or are not allowed to install document reader of particular type, this application may come in hand for you. Simply upload your document, and Docureader.top will transform it into readable format in a few seconds. Why choose Docureader.top?

  1. Unlimited sharing - you can upload document of any size. If we are able to convert it into readable format, you have it here - saved for later or immediate reading
  2. Cross-platform - no compromised when reading your document. We support most of modern browers without the need of installing any of external plugins. If your device can oper a browser - then you can read any document on it
  3. Simple uploading - no need to register. Just enter your email, title of document and select the file, we do the rest. Once the document is ready for you, you will receive automatic email from us.

Previous 10

Next 10