Page 1 of 3
MSDS: EXR01:3
Issued: 18th May 2000
EXCENEL庐 RTU Antibiotic Suspension for Injection (VETERINARY)
Pharmacia & Upjohn Pty Limited
ACN 000 185 526
MATERIAL SAFETY 59 Kirby Street
Rydalmere NSW 2116
DATA SHEET Australia
Ph:+61 2 9890 7177
Fax:+61 2 9890 5391
-NON HAZARDOUS ACCORDING TO THE CRITERIA OF WORKSAFE AUSTRALIA-
IDENTIFICATION
PRODUCT NAME:
EXCENEL庐 RTU Antibiotic Suspension for Injection
Other Names: U-64; 279A; Naxcel庐
Manufacturers Product Code: EDP 400199
UN: Not Applicable CLASS: Not Applicable SUB RISK: Not Applicable HAZCHEM CODE: Not Applicable
EPG: Not Applicable PACKAGING GROUP: Not Applicable POISON SCHEDULE: 4
USE: Injectable antibiotic for veterinary use only.
PHYSICAL DESCRIPTION/PROPERTIES:
Appearance: Off-white to buff coloured suspension.
> 232oC.
Boiling Point:
-5 to 0 oC (solidifies).
Freezing Point:
Vapour Pressure: < 1 mm Hg.
Specific Gravity: 0.935 - 0.942
252 oC
Flash Point:
343 oC
Autoignition temperature:
Percent Volatiles: Nil.
Solubility: Insoluble in water. Soluble in non-polar solvents such as hydrocarbons.
pH: Not applicable.
OTHER PROPERTIES: Nil.
INGREDIENTS CAS No PROPORTION
Ceftiofur hydrochloride micronized 104010-37-9 50mg/mL
Other ingredients determined not to be hazardous Balance
HEALTH HAZARD INFORMATION
ACUTE HEALTH EFFECTS
Swallowed: May cause an acute hypersensitivity reaction.
Eye: May cause eye irritation.
Skin: May cause mild to severe allergic reactions in some individuals.
Inhalation: May cause mild to severe allergic reactions in some individuals.
CHRONIC HEALTH EFFECTS:
Page 2 of 3
MSDS: EXR01:3
Issued: 18th May 2000
EXCENEL庐 RTU Antibiotic Suspension for Injection (VETERINARY)
Pharmacia & Upjohn Pty Limited
ACN 000 185 526
MATERIAL SAFETY 59 Kirby Street
Rydalmere NSW 2116
DATA SHEET Australia
Ph:+61 2 9890 7177
Fax:+61 2 9890 5391
(The health effects given here refer to the bulk drug more than the finished product)
Repeated exposure may lead to sensitization. Manifestations of an allergic response may include skin rash, fever,
bronchospasm, angioedema (swelling of the lips, tongue and face accompanied by asthmatic breathing and hives)
and anaplylaxis. Oral ingestion of large quantities of ceftiofur hydrochloride may also cause diarrhoea, nausea,
vomiting and anaemia. Cottonseed oil (carrier) is considered practically nontoxic. Ingestion of large amounts may
have a laxative effect.
TOXICITY DATA:
LD50 (Rat, intraperitoneal): 881 mg/kg (for ceftiofur hydrochloride)
Oral toxicity (pig): Administration of up to 150 mg/kg/day of ceftiofur hydrochloride orally for five days was
well tolerated and free of toxic effects in baby pigs.
Genotoxicity: Ceftiofur was negative in the Ames Assay, Micronucleus test, V9 mammalian cell
mutation assay and Unscheduled DNA synthesis assay. In the invitro chromosome
aberration assay using CHO cells (in the absence of S9 metabolic activation), lengthy
treatment with high doses of ceftiofur sodium resulted in increased frequency of
aberrations. Aberrations were in the categories of chromatid breaks and gaps and
isochromatid gaps. No evidence of the formation of rearrangements could be seen in these
cells.
Carcinogenicity: Ingredient(s) are not listed as carcinogenic by IARC, NTP or OSHA.
Mutagenicity: Negative
Teratogenicity: Ceftiofur sodium was not teratogenic in rats at oral doses up to 3200 mg/kg/day.
Sensitivity: May cause hypersensitivity reactions
Reproduction/Fertility: The NOEL for reproductive effects in the rat for ceftiofur sodium is 1000 mg/kg/day
orally. Oral administration at this level did not cause adverse effects upon fertility or
reproductive performance of F0 and F1 generation animals. Likewise, no adverse effects
were observed in the growth and viability of the F2 litter through the weaning period.
FIRST AID PROCEDURES:
Swallowed: Contact a physician or Poisons Information Centre.
Eye: Flush with water for 15 minutes. Hold eyelids open to assure complete contact with water.
Skin: Wash with soap and water. Remove contaminated clothing.
Inhalation: Remove from exposure.
First Aid Facilities: No specific recommendation.
ADVICE TO DOCTOR:
Serious acute hypersensitivity reactions may require treatment with epinephrin, and other emergency measures
including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway
management as indicated clinically. Hypersensitivity to other beta-Lactam antibiotics such as penicillin may be
aggravated by exposure.
PRECAUTIONS FOR USE
EXPOSURE STANDARDS:
None assigned by Worksafe Australia. Pharmacia & Upjohn suggested limit: 0.2mg/cubic metre.
ENGINEERING CONTROLS:
The measures below refer to industrial situations, not to the end-use product.
Ventilation: Local exhaust
PERSONAL PROTECTION:
Page 3 of 3
MSDS: EXR01:3
Issued: 18th May 2000
EXCENEL庐 RTU Antibiotic Suspension for Injection (VETERINARY)
Pharmacia & Upjohn Pty Limited
ACN 000 185 526
MATERIAL SAFETY 59 Kirby Street
Rydalmere NSW 2116
DATA SHEET Australia
Ph:+61 2 9890 7177
Fax:+61 2 9890 5391
Respiratory protection: Not required.
Protective gloves: Not required.
Eye protection: Not required.
Other protective equipment: Not required. Persons with known sensitivities to penicillin or to the cephalosporin
group of antibiotics should avoid direct contact with this product.
FLAMMABILITY:
Flammable limits: Not available
SAFE HANDLING INFORMATION
STORAGE & TRANSPORT
No special transport requirements necessary.
Store below 30螕C (Room temperature). Protect from light. Keep out of reach of children.
SPILLS & DISPOSAL
Provide adequate ventilation and respiratory, skin and eye protection to prevent overexposure. For large spills,
absorb on sand, vermiculite, spill pillows or other appropriate absorbent material and place in container. Clean
surfaces with an oil cutting cleaning agent. Rinse affected surface with household ammonia. Allow solution to
stand for 5 minutes. Place all wipes and rags used for cleaning in waste containers. The liquid generated from
cleaning can be disposed in the sanitary sewer. For small spills, place broken material in a container. Absorb
spill with paper and place in a container.
WASTE DISPOSAL METHOD
Incineration or suitable land-fill burial.
FIRE EXPLOSION
Wear self-contained breathing apparatus and full body protective equipment. Hazardous combustion products
include carbon monoxide, carbon dioxide, nitrogen and sulphur oxides
Extinguish using water, carbon dioxide or dry chemical.
OTHER INFORMATION
Nil
CONTACT POINT
Technical Services Veterinarian
Business Hours: (02) 9890 7177
After Hours: 0412 004 113
|