SDS Number 110539 Approved/Revised 18-Jul-2008 Version 10
CEFTIN TABLETS
Material
SAFETY DATA SHEET
* 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material CEFTIN TABLETS
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CEFTIN TABLETS 125 MG * CEFTIN TABLETS 250 MG * CEFTIN TABLETS 500 MG *
Synonym(s)
CEFTUM TABLETS * CEFUROX TABLETS * CUROCEF TABLETS * ELOBACT TABLETS *
ORACEF TABLETS * ZINADOL TABLETS * ZINAT TABLETS * ZINNAT TABLETS * ZIPOS
TABLETS * ZOREF TABLETS * NDC NO 0173-0387-00 * NDC NO 0173-0394-00 *
CEFUROXIME AXETIL, 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.
CEFUROXIME AXETIL 64544-07-6 51.6 to 54.9
NON-HAZARDOUS INGREDIENTS Unassigned 45.1 to 48.4
3. HAZARDS IDENTIFICATION
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Expected to be non-combustible.
Fire and Explosion
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Exposure might occur via skin; eyes; ingestion.
Health
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; vomiting; diarrhoea.
Health effects information is based on hazards of components.
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No information is available about the potential of this product to produce adverse
Environment
environmental effects.
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SDS Number 110539 Approved/Revised 18-Jul-2008 Version 10
CEFTIN TABLETS
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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Physical form suggests that risk of inhalation exposure is negligible.
Inhalation
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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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Not expected for the product, although the packaging is combustible.
Fire and Explosion Hazards
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Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers
Extinguishing Media
may be ineffective.
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For single units (packages): No special requirements needed. For larger amounts (multiple
Special Firefighting
packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved
Procedures
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
Avoid breaking or crushing tablets.
General Requirements
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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 110539 Approved/Revised 18-Jul-2008 Version 10
CEFTIN TABLETS
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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CEFUROXIME AXETIL
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
Tablet.
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.
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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.
Oral Toxicity
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Can produce respiratory irritation. Adverse effects might occur following inhalation.
Inhalation Toxicity
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Irritation might occur following direct contact.
Skin Effects
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Irritation might occur following direct contact with eyes.
Eye Effects
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Allergic skin reactions might occur following dermal exposure. Assessment based upon
Sensitisation
effects of structurally similar substances.
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Not expected to be genotoxic under occupational exposure conditions. Assessment based
Genetic Toxicity
upon effects of structurally similar substances.
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Not expected to produce cancer in humans under occupational exposure conditions. No
Carcinogenicity
components are listed as carcinogens by GSK, IARC, NTP or US OSHA.
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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.
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None known for occupational exposure.
Other Adverse Effects
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SDS Number 110539 Approved/Revised 18-Jul-2008 Version 10
CEFTIN TABLETS
Material
12. ECOLOGICAL INFORMATION
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This material contains an active pharmaceutical ingredient that has been tested, and no
Summary
environmental effects have been identified. 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: > 100 mg/l, 3 Hours, Activated sludge
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This material contains an active pharmaceutical ingredient that is toxic
Microbial Growth
to these microorganisms.
Inhibition
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0.2 mg/l, , Azotobacter beijerinckii
Minimum Inhibition
0.2 mg/l, , Nostoc commune
Concentration:
> 1 mg/l, , Pseudomonas aeruginosa
> 1 mg/l, , Trichoderma harzianum
> 1 mg/l, , Aspergillus niger
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This material contains an active pharmaceutical ingredient that is not
Algal
toxic to algae.
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IC50: > 91 mg/l, 72 Hours, Selenastrum
capricornutum, green algae, Static test
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NOEC: 91 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Static test
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This material contains an active pharmaceutical ingredient that is not
Daphnid
toxic to daphnids.
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EC50: > 1000 mg/l, 48 Hours, Daphnia magna, Static
test
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NOEC: > 1000 mg/l, 48 Hours, Daphnia magna, Static
test
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This material contains an active pharmaceutical ingredient that is not
Fish
toxic to fish.
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Adult Oncorhyncus mykiss, rainbow trout
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EC50: > 120 mg/l, 96 Hours, Static test
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Adult Oncorhyncus mykiss, rainbow trout
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NOEC: 120 mg/l, 96 Hours, Static test
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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 will not readily enter into the
Volatility
air from hard surfaces or from a container of the pure substance. This material contains an
active pharmaceutical ingredient that will not readily enter into air from water.
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Henrys Law Constant Estimated at 25 C
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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 1.09 to 1.19
(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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SDS Number 110539 Approved/Revised 18-Jul-2008 Version 10
CEFTIN TABLETS
Material
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Half-Life, Neutral: 30.2 Hours
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Half-Life, Acidic: 299 Hours
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Half-Life, Basic: 1.05 Hours
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This material contains an active pharmaceutical ingredient that is likely to undergo
Photolysis
photodegradation.
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UV/Visible Spectrum: 290 nm
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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.
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Aerobic - Ready
Percent Degradation: 42 %, 64 days, Modified Sturm test.
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Aerobic - Ready
Percent Degradation: 28 %, 28 days, Modified Sturm test.
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Aerobic - Inherent
Percent Degradation: 74 %, < 1 day, Modified Zahn-Wellens, primary biodegradation,
loss of parent., Activated sludge
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Aerobic - Soil
Percent Degradation: 42.8 to 80 %, 64 days
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This material contains an active pharmaceutical ingredient that will not have a tendency to
Bioaccumulation
bioaccumulate in the food chain.
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
Transportation and shipping of this product is not restricted. It has no known,
Transport Information
significant hazards requiring special packaging or labelling for air, maritime, US or
European ground transport purposes.
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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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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SDS Version Number
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SDS Number 110539 Approved/Revised 18-Jul-2008 Version 10
CEFTIN TABLETS
Material
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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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