Download MSDS - B. Braun Medical Inc.

MATERIAL SAFETY DATA SHEET (MSDS)
2525 McGaw Ave
Irvine, CA 92614, USA
(949) 660-2000
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HMIS (USA)
Health Hazard:
Fire Hazard:
Reactivity:
Special:
1
1
1
Allergen
CEFUROXIME FOR INJECTION USP AND DEXTROSE INJECTION USP
B. Braun Catalog No: 3112-11, 3114-11
Revision Date: May 17, 2006
EMERGENCY OVERVIEW - ALLERGEN
SECTION 1- IDENTIFICATION
Drug Chamber
Common Name:
Cefuroxime Sodium
Formula:
C16H15N4NaO8S
Synonym:
N/F
Chemical Name:
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3[[(aminocarbonyl)oxy]methyl]-7-[[2-furanyl(methoxyimino)acetyl]amino]-8oxo-, monosodium salt [6R-[6alpha, 7beta(Z)]]-
CAS Number:
56238-63-2
Chemical Family:
Cephalosporin
Therapeutic Category:
Antibacterial
RTECS Number: XI0330000
Diluent Chamber
Formula:
C6H12O6/H2O
Common Name:
Dextrose Injection
Synonym:
Glucose Solution, Sugar Solution, Cerelose Solution
Chemical Name:
N/A
CAS Number:
50-99-7 (Dextrose)
Chemical Family:
Table Sugar
Therapeutic Category:
None
RTECS Number: N/A
SECTION 2- INGREDIENT INFORMATION
Drug Chamber
Principle Component:
Cefuroxime Sodium
Percent: Pure Material-Solid
Exposure Limit: N/F
MATERIAL SAFETY DATA SHEET (MSDS)
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Diluent Chamber
Principle Component:
Minor Component:
Water
Dextrose
Percent: 95%
Percent: < 5%
Exposure Limit: N/F
SECTION 3-HEALTH HAZARD INFORMATION
Cefuroxime Sodium
Usual Adult Dose:
Cefuroxime is administered by intravenous infusion; doses range from 750 mg
to 1.5 grams every 8 hours.
Adverse Effects:
Adverse effects of Cephalosporins may include nausea; vomiting; taste
alteration; decrease salivation; heartburn; decrease appetite; severe abdominal
cramps, tenderness, or pain; diarrhea; which may be watery, bloody or severe;
fever; unusual bruising or bleeding; sore mouth or tongue; and anal or genital
itching. Drinking alcohol or using alcohol-containing preparations while
exposed to this material may cause abdominal cramps, nausea, vomiting,
headache, weakness, and flushing. Possible allergic reaction to material if
inhaled, ingested or in contact with skin.
Overdose Effect:
Overdosage of cephalosporins can cause cerebral irritation leading to
convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and
peritoneal dialysis.
Acute:
Possible eye, skin, gastrointestinal and/or respiratory tract irritation.
Chronic:
Possible hypersensitization, antibiotic-associated pseudo membranous colitis,
and super infections.
Inhalation:
May cause irritation. Remove to fresh air.
Eye:
May cause irritation. Flush with copious quantities of water for at least fifteen
minutes.
Skin:
May cause irritation. Flush with copious quantities of water.
Ingestion:
May cause irritation. Flush out mouth with water. This material is poorly
absorbed from the gastrointestinal tract.
Medical Conditions
Aggregated by Exposure:
Hypersensitivity to material, active alcoholism, history of bleeding disorders,
kidney function impairment, and gastrointestinal disease, especially ulcerative
colitis, regional enteritis, or antibiotic-associated colitis.
Cross Sensitivity:
Individuals sensitive to penicillin, penicillin derivatives, penicillamine, other
cephalosporins, or cephamycin may be sensitive to this material also.
Pregnancy Comments:
Adequate and well-controlled pregnancy studies in humans have not been
done; however, studies in rats and mice at doses 23 times the recommended
human dose have not indicated that Cefuroxime axetil causes fetal harm.
Pregnancy Category:
B
MATERIAL SAFETY DATA SHEET (MSDS)
Dextrose Injection
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Non-hazardous
SECTION 4 – FIRST AID MEASURES
Cefuroxime Sodium
General:
Remove from exposure. Remove contaminated clothing. Person developing
serious hypersensitivity (anaphylactic) reactions must receive immediate
medical attention. If person is not breathing, give artificial respiration. If
breathing is difficult give oxygen. Obtain medical attention.
Overdose Treatment:
Treatment is symptomatic and supportive and may include:
(1) For acute hypersensitivity – Administer the usual agents (antihistamines,
corticosteroids, or epinephrine, or other pressor amines), oxygen, and
airway management, including intubation.
(2) For antibiotic-associated pseudo membranous colitis – Moderate to
severe cases may require fluid, electrolyte and protein replacement. Oral
doses of metronidazole, bacitracin, cholestyramine, or vancomycin may
be used; repeat as necessary. Do NOT use antiperistaltic antidiarrheals for
severe watery diarrhea.
(3) Administer anticonvulsants if clinically indicated. [USP DI 20th ed. 2000]
Dextrose Injection
General:
Dextrose Injection is non-hazardous. Wash affected area with water.
SECTION 5 – TOXICOLOGICAL INFORMATION
Cefuroxime Sodium
Oral Rat:
LD50: >10g/kg
Oral Mouse:
LD50: > 10g/Kg
Irritancy Data:
N/F
Target Organ(s):
N/F
Listed as a Carcinogen?
NTP: No
Dextrose Injection
N/A
IARC: No
OSHA: No
Other: No
SECTION 6 – FIRE FIGHTING MEASURES
Cefuroxime Sodium
Health:
1
Fire: 1
Reactivity:
Extinguisher Media:
1
Special: A (Allergen)
Water spray, dry chemical, carbon dioxide or foams as appropriate for
surrounding fire and materials.
MATERIAL SAFETY DATA SHEET (MSDS)
Fire and Explosion
Hazards:
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This material is assumed to be combustible. As with all dry powders, it is
advisable to ground mechanical equipment in contact with dry material to
dissipate the potential buildup of static electricity.
Firefighting Procedures:
As with all fires, evacuate personnel to a safe area. Firefighters should use
self-contained breathing equipment and protective clothing.
Dextrose Injection
Non flammable, non combustible
SECTION 7 – PHYSICAL HAZARDS
Cefuroxime Sodium
Conditions to Avoid:
Avoid exposure to light, heat and moisture.
Incompatibilities:
Oxidizing agents.
Decomposition Products:
When heated to decomposition material emits toxic fumes of NOx, SOx and
Na2O. Emits toxic fumes under fire conditions.
Stable?
Yes
Dextrose Injection
Non-hazardous
Hazardous Polymerization: No
SECTION 8 – HANDLING / SPILL / DISPOSAL MEASURES
Cefuroxime Sodium
Handling:
As a general rule, when handling Cefuroxime sodium avoid all contact and
inhalation of dust. Wash thoroughly after handling.
Storage:
Store per label instructions to ensure product integrity.
Spill Response:
Wear approved respiratory protection, chemically compatible gloves and
protective clothing. Wipe up spillage or collect spillage using a high efficiency
vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeled
container for disposal. Wash spill site with plenty of water.
Disposal:
Dispose of waste in accordance with all applicable Federal, State and local
laws.
Dextrose Injection
No special handling, storage, spill response and disposal required.
Drug Product
Dispose of waste drug product (constituted solution) in accordance with all
applicable Federal, State and local laws.
MATERIAL SAFETY DATA SHEET (MSDS)
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SECTION 9 – EXPOSURE CONTROLS / PERSONAL PROTECTION
Cefuroxime Sodium
Respiratory Protection:
When working with small quantities in a well-ventilated area, respiratory
protection may not be required. The use of an approved dust mask is
recommended.
Ventilation:
No special ventilation required.
Gloves:
Rubber (use non-latex gloves if possible)
Eye Protection:
Safety Glasses.
Protective Clothing:
Protect exposed skin.
Dextrose Injection
N/A
SECTION 10 – PHYSICAL AND CHEMICAL PROPERTIES
Cefuroxime Sodium
Appearance and Odor:
White to beige powder.
Melting Range:
216°C (Decomposes)
Solubility in Water:
Freely Soluble.
Vapor Density: N/F
Boiling Point:
N/F
Evaporation Rate: N/F
Specific Gravity:
N/F
Reactivity in Water: N/F
Vapor Pressure:
N/F
%Volatile by Volume: N/F
Dextrose Injection
N/A
SECTION 11 – OTHER INFORMATION
Information provided in this MSDS is intended to be used in the handling of this material in the work place.
This MSDS is not a substitute for the direction for use or product literature that may accompany the finished
product. All information contained in this MSDS has been assembled from other published documents and are
assumed to be accurate. In the event of an adverse incident associated with this material, this MSDS is not
intended to be a substitute for consultation with appropriately qualified personnel.
For additional information contact:
B. Braun Medical Inc.
[Clinical & Technical Support Line]
1-800-854-6851
MATERIAL SAFETY DATA SHEET (MSDS)
SECTION 12 - GLOSSARY
CAS
EINECS
HMIS
IARC
MSDS
N/A
N/F
NTP
OSHA
RTECS
USP
Chemical Abstract Service
European Inventory of Existing Chemical Substance
Hazardous Material Identification System
International Agency for Research on Cancer
Material Safety Data Sheet
Not Applicable
Not Found
National Toxicology Program
Occupational Safety and Health Administration
Registry of Toxic Effects of Chemical Substances
United States Pharmacopeia
SECTION 13 - REFERENCES
USP-MSDS for Cefuroxime Sodium
Eli Lilly-MSDS for Cefuroxime Sodium
B. Braun Medical Inc. DFU for Cefuroxime for Injection and Dextrose Injection
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