SDS Number 110558 Approved/Revised 15-Jul-2008 Version 15
FORTAZ (CEFTAZIDIME FOR INJECTION)
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material FORTAZ (CEFTAZIDIME FOR INJECTION)
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FORTAZ 500MG VIAL * FORTAZ 1G VIAL * FORTAZ 2G VIAL * FORTAZ 1G IV INFUSION
Synonym(s)
PACK * FORTAZ 2G IV INFUSION PACK * FORTAZ 6G PHARMACY BULK PACK *
FORTAZ 1G ADD-VANTAGE VIALS * FORTAZ 2G ADD-VANTAGE VIALS * FORTUM
INJECTION 250MG VIAL * FORTUM INJECTION 500MG VIAL * FORTUM INJECTION 1G
VIAL * FORTUM INJECTION 2G VIAL * FORTUM INJECTION 3G VIAL * FORTUM
INFUSION 2G VIAL * FORTUM MONOVIAL 2G VIAL * NDC NO 0173-0377-10 * NDC NO
0173-0378-10 * NDC NO 0173-0379-34 * NDC NO 0173-0382-37 * NDC NO 0173-0434-00 *
NDC NO 0173-0435-00 * CEFTAZIDIME PENTAHYDRATE, FORMULATED PRODUCT
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GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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UK General Information: +44-20-8047-5000
Transport Emergency (EU) +44-1865-407333
Medical Emergency +1-612-221-3999, Ext 221
Information and Advice: US number, available 24 hours
Multi-language response
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GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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US General Information: +1-888-825-5249
Transport Emergency (non EU) +1-703-527-3887
US number, available 24 hours
Multi-language response
.
2. COMPOSITION / INFORMATION ON INGREDIENTS
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Ingredients CAS # Percent EC-No.
CEFTAZIDIME PENTAHYDRATE 78439-06-2 90.9
NON-HAZARDOUS INGREDIENTS Unassigned 9.1
3. HAZARDS IDENTIFICATION
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Assume that this product is capable of sustaining combustion.
Fire and Explosion
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Caution - Pharmaceutical agent.
Health
Exposure might occur via skin; eyes; ingestion; inhalation.
May produce allergic skin reactions.
Respiratory allergen.
Possible effects of overexposure in the workplace include: symptoms of hypersensitivity
(such as skin rash, hives, itching, and difficulty breathing); nausea; gastrointestinal distress;
vomiting; diarrhoea.
Health effects information is based on hazards of components.
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Very toxic to aquatic organisms.
Environment
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SDS Number 110558 Approved/Revised 15-Jul-2008 Version 15
FORTAZ (CEFTAZIDIME FOR INJECTION)
Material
4. FIRST-AID MEASURES
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Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the
Ingestion
exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the
exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention.
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Using appropriate personal protective equipment, move exposed subject to fresh air. If
Inhalation
breathing is difficult or ceases, ensure and maintain ventilation. Give oxygen as appropriate.
The exposed subject should be kept warm and at rest. Obtain medical attention in cases of
known or possible over exposure, or with symptoms including chest pain, difficulty breathing,
loss of consciousness or other adverse effects, which may be delayed.
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Using appropriate personal protective equipment, remove contaminated clothing and flush
Skin Contact
exposed area with large amounts of water. Obtain medical attention if skin reaction occurs,
which may be immediate or delayed.
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Wash immediately with clean and gently flowing water. Continue for at least 15 minutes.
Eye Contact
Obtain medical attention.
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NOTES TO HEALTH PROFESSIONALS
Treat according to locally accepted protocols. For additional guidance, refer to the current
Medical Treatment
prescribing information or to the local poison control information centre. Medical treatment in
cases of overexposure should be treated as an overdose of a cephalosporin antibiotic. In
allergic individuals, exposure to this material may require treatment for initial or delayed
allergic symptoms and signs. This may include immediate and/or delayed treatment of
anaphylactic reactions.
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Refer to prescribing information for detailed description of medical conditions caused by or
Medical Conditions
aggravated by overexposure to this product. Ocular symptoms may be indicative of allergic
Caused or Aggravated by
reaction. Pulmonary symptoms may indicate allergic reaction or asthma. This material may
Exposure
cause or aggravate allergy to cephalosporin antibiotics.
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No specific antidotes are recommended.
Antidotes
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5. FIRE-FIGHTING MEASURES
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The combustibility of the product is not known, however the packaging is combustible.
Fire and Explosion Hazards
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Water or foam extinguishers are recommended.
Extinguishing Media
Carbon dioxide or dry powder extinguishers may be ineffective.
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For single units (packages): No special requirements needed.
Special Firefighting
For larger amounts (multiple packages/pallets) of product: Since toxic, corrosive or
Procedures
flammable vapours might be evolved from fires involving this product and associated
packaging, self contained breathing apparatus and full protective equipment are
recommended for firefighters.
If possible, contain and collect firefighting water for later disposal.
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Toxic, corrosive or flammable thermal decomposition products are expected when the
Hazardous Combustion
product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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Wear protective clothing and equipment consistent with the degree of hazard.
Personal Precautions
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For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage
Environmental Precautions
systems.
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Collect and place it in a suitable, properly labelled container for recovery or disposal.
Clean-up Methods
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No specific decontamination or detoxification procedures have been identified for this
Decontamination Procedures
product. Water can be used for clean-up and decontamination operations.
7. HANDLING AND STORAGE
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HANDLING
No special control measures required for the normal handling of this product. Normal room
General Requirements
ventilation is expected to be adequate for routine handling of this product.
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No storage requirements necessary for occupational hazards. Follow product information
STORAGE
storage instructions to maintain efficacy.
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SDS Number 110558 Approved/Revised 15-Jul-2008 Version 15
FORTAZ (CEFTAZIDIME FOR INJECTION)
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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CEFTAZIDIME PENTAHYDRATE
INGREDIENT
3
GSK Occupational Hazard
Category
RESPIRATORY SENSITISER, SKIN
GSK Occupational 100 mcg/m3 (15 MIN STEL)
SENSITISER
Exposure Limit
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For advice on suitable monitoring methods, seek guidance from a qualified environment,
Occupational Hygiene Air
health and safety professional.
Monitoring Methods
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ENGINEERING CONTROLS
An Exposure Control Approach (ECA) is established for operations involving this material
Exposure Controls
based upon the OEL/Occupational Hazard Category and the outcome of a site- or
operation-specific risk assessment. Refer to the Exposure Control Matrix for more information
about how ECA's are assigned and how to interpret them.
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PERSONAL PROTECTIVE EQUIPMENT
Wear approved safety glasses with side shields if eye contact is possible.
Eye Protection
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If respiratory protective equipment (RPE) is used, the type of RPE will depend upon air
Respirators
concentrations present, required protection factor as well as hazards, physical properties and
warning properties of substances present.
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Follow all local regulations if personal protective equipment (PPE) is used in the workplace.
Other Equipment or
Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after
Procedures
handling.
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
White/off-white.
Colour
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Powder.
Physical Form
10. STABILITY AND REACTIVITY
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This product is expected to be stable.
Stability
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None for normal handling of this product.
Conditions to Avoid
11. TOXICOLOGY INFORMATION
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This material is an antibiotic; a cephalosporin. It is an agent intended for the treatment of
Pharmacological Effects
bacterial infections. Adverse effects of overexposure might include: nausea; vomiting;
gastrointestinal distress; diarrhoea.
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No specific target organ effects have been identified.
Target Organ Effects
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Routes of Exposure
Not expected to be toxic following ingestion. Assessment based upon effects of individual
Oral Toxicity
components.
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Overexposure may result in irritation of the respiratory tract. Adverse effects might occur
Inhalation Toxicity
following inhalation. Assessment based upon effects of individual components.
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Irritation might occur following direct contact. Assessment based upon effects of individual
Skin Effects
components.
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Minor irritation might occur following direct contact with eyes. Assessment based upon
Eye Effects
effects of individual components.
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Allergic skin reactions might occur following dermal exposure. Respiratory sensitisation
Sensitisation
(allergic) reactions might occur following exposure. Assessment based upon effects of
individual components.
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Not expected to be genotoxic under occupational exposure conditions. Assessment based
Genetic Toxicity
upon effects of individual components.
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No components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
Carcinogenicity
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SDS Number 110558 Approved/Revised 15-Jul-2008 Version 15
FORTAZ (CEFTAZIDIME FOR INJECTION)
Material
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Not expected to produce adverse effects on fertility or development under occupational
Reproductive Effects
exposure conditions. No adverse effects have been reported following extensive use or
exposure in humans. Assessment based upon effects of individual components.
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None known for this material in humans.
Other Adverse Effects
12. ECOLOGICAL INFORMATION
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This material contains an active pharmaceutical ingredient that has been tested and which
Summary
may be harmful if released directly to the environment. Consult the MSDS of the active
ingredient for specific information about potential environmental effects. Appropriate
precautions should be taken to limit release of this material to the environment. Local
regulations and procedures should be consulted prior to environmental release.
Specific information on the active pharmaceutical ingredient is provided below.
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ECOTOXICITY
Aquatic
This material contains an active pharmaceutical ingredient that is not
Activated Sludge
toxic to activated sludge microorganisms.
Respiration
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IC50: > 103 mg/l, 3 Hours, Activated sludge, Nominal
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NOEC: 103 mg/l
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This material contains an active pharmaceutical ingredient that is
Microbial Growth
harmful to these microorganisms.
Inhibition
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2 mg/l, , Pseudomonas, Measured
Minimum Inhibition
Concentration:
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This material contains an active pharmaceutical ingredient that is very
Algal
toxic to algae.
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IC50: 0.025 mg/l, 72 Hours, , Measured
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NOEC: 0.013 mg/l
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This material contains an active pharmaceutical ingredient that is not
Daphnid
toxic to daphnids.
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EC50: > 106 mg/l, 48 Hours, Daphnia magna,
Measured
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NOEC: 106 mg/l
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This material contains an active pharmaceutical ingredient that is not
Fish
toxic to fish.
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Juvenile Oncorhyncus mykiss, rainbow trout
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EC50: > 106 mg/l, 96 Hours, Measured
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NOEC: 106 mg/l
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MOBILITY
This material contains an active pharmaceutical ingredient that for environmental fate
Solubility
predictions has solubility in water.
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This material contains an active pharmaceutical ingredient that is not likely to adsorb to soil
Adsorption
or sediment if released directly to the environment. This material contains an active
pharmaceutical ingredient that is not likely to adsorb to sludge or biomass if released directly
to the environment.
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Soil Sediment Sorption 0.78, Measured at pH 7
(log Koc):
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This material contains an active pharmaceutical ingredient with octanol/water partition
Partitioning
coefficient data that suggests that for environmental fate predictions the active
pharmaceutical ingredient will not have the tendency to distribute into fats.
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PERSISTENCE/DEGRADATION
This material contains an active pharmaceutical ingredient that has been shown to be
Hydrolysis
chemically unstable in water. Hydrolysis may be a significant depletion mechanism.
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Half-Life, Acidic: < 100 Hours, Measured
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Half-Life, Basic: < 1 Hours, Measured
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SDS Number 110558 Approved/Revised 15-Jul-2008 Version 15
FORTAZ (CEFTAZIDIME FOR INJECTION)
Material
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This material contains an active pharmaceutical ingredient that is not readily biodegradable
Biodegradation
but is inherently biodegradable (as defined by 1993 OECD Testing Guidelines) and is not
expected to persist in the environment. Cephalosporins are generally susceptible to
degradation by a number of micro-organisms found in wastewater treatment plants and the
general environment. Resulting degradation products are readily mineralised by
environmental micro-organisms.
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Aerobic - Inherent
Percent Degradation: 34 %, 14 days, Modified Zahn-Wellens, primary biodegradation,
loss of parent., Activated sludge
13. DISPOSAL CONSIDERATIONS
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Collect for recycling or recovery if possible. The disposal method for rejected
Disposal Recommendations
products/returned goods must ensure that they cannot be re-sold or re-used.
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Observe all local and national regulations when disposing of this product.
Regulatory Requirements
14. TRANSPORT INFORMATION
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The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons
trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous
goods for transport.
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UN Classification and Labelling
CEFTAZIDIME PENTAHYDRATE, FORMULATED PRODUCT
Technical Name
Environmentally hazardous substance, solid, nos
Proper Shipping Name
(FORTAZ (CEFTAZIDIME FOR INJECTION))
UN 3077
UN Number
9
Class/Division
III
Packing Group
Class 9
Risk Label(s)
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International Air Transport (IATA Requirements)
Classification and Labelling See SP A97.
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International Maritime Transport (IMDG Requirements)
Classification and Labelling See SP909 / 944.
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US Domestic Transport (DOT Requirements)
Classification and Labelling See DOT SP146.
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European Ground Transport (ADR/RID Requirements)
Classification and Labelling As UN Classification and Labelling above
15. REGULATORY INFORMATION
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The information included below is an overview of the major regulatory requirements. It should not be considered to be an
exhaustive summary. Local regulations should be consulted for additional requirements.
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EU Classification and Labelling
Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product,
cosmetic product or medical device.
For waste disposal purpose, this product should be classified in line with the European Waste Catalogue criteria.
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SDS Number 110558 Approved/Revised 15-Jul-2008 Version 15
FORTAZ (CEFTAZIDIME FOR INJECTION)
Material
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US OSHA Standard (29 CFR Part 1910.1200)
This dosage form is exempt from the requirements of the OSHA Hazard Communication
Classification
Standard.
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Other US Regulations
Exempt
TSCA Status
16. OTHER INFORMATION
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GSK Hazard Determination
References
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15
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF
COMPANY
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The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of
issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine
the applicability of this information and the suitability of the material or product for any particular purpose.
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