SDS Number 110538 Approved/Revised 04-Apr-2007 Version 12
CEFTIN FOR ORAL SUSPENSION
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
Material CEFTIN FOR ORAL SUSPENSION
CEFTIN SUSPENSION 125 MG/5 ML * CEFTIN SUSPENSION 250 MG/5 ML *
Synonyms
CEFTIN ORAL SUSPENSION * CEFTUM ORAL SUSPENSION 125 MG/5 ML
* CEFUROX ORAL SUSPENSION * CEFOCEF ORAL SUSPENSION *
ELOBACT ORAL SUSPENSION * ELOBACT GRANULES * ELOBACT 125 MG
DOSIERBRIEFE * ZINADOL ORAL SUSPENSION * ZINAT SUSPENSION *
ZINNAT SUSPENSION SACHET 125 MG * ZINNAT SUSPENSION 25 MG/ML
* ZINACEF SUSPENSION * ZIPOS ORAL SUSPENSION * ZOREF ORAL
SUSPENSION * NDC NO 0173-0740-00 * NDC NO 0173-0741-00 * NDC NO
0173-0741-10 * CEFUROXIME AXETIL, FORMULATED PRODUCT
GlaxoSmithKline, Corporate Environment, Health & Safety
Company Name
980 Great West Road
Brentford, Middlesex TW8 9GS UK
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
GlaxoSmithKline, Corporate Environment, Health & Safety
One Franklin Plaza, 200 N 16th Street
Philadelphia, PA 19102-1225 US
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
Percentage
Ingredients CAS RN
CEFUROXIME AXETIL 3.5 to 7.5
64544-07-6
NON-HAZARDOUS INGREDIENTS 92.5 to 96.5
Unassigned
3. HAZARDS IDENTIFICATION
Assume that this product is capable of sustaining combustion.
Fire and Explosion
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SDS Number 110538 Approved/Revised 04-Apr-2007 Version 12
CEFTIN FOR ORAL SUSPENSION
Material
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; vomiting; diarrhoea.
Health effects information is based on hazards of components.
Environment No information is available about the potential of this product to produce
adverse environmental effects.
4. FIRST-AID MEASURES
Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the 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.
Inhalation Physical form suggests that risk of inhalation exposure is negligible.
Skin Contact Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
delayed.
Eye Contact Wash immediately with clean and gently flowing water. Continue for at least
15 minutes. Obtain medical attention.
NOTES TO HEALTH PROFESSIONALS
Medical Treatment Treat according to locally accepted protocols. For additional guidance, refer
to the current 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.
Medical Conditions Refer to prescribing information for detailed description of medical
conditions caused by or aggravated by overexposure to this product. Ocular
Caused or Aggravated
symptoms may be indicative of allergic reaction. Pulmonary symptoms may
by Exposure
indicate allergic reaction or asthma. This material may cause or aggravate
allergy to cephalosporin antibiotics.
Antidotes No specific antidotes are recommended.
5. FIRE-FIGHTING MEASURES
Fire and Explosion The combustibility of the product is not known, however the packaging is
combustible.
Hazards
Extinguishing Media Water or foam extinguishers are recommended.
Carbon dioxide or dry powder extinguishers may be ineffective.
Special Firefighting For single units (packages): No special requirements needed.
For larger amounts (multiple packages/pallets) of product: Since toxic,
Procedures
corrosive or 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.
Hazardous Combustion Toxic, corrosive or flammable thermal decomposition products are
expected when the product is exposed to fire.
Products
6. ACCIDENTAL RELEASE MEASURES
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SDS Number 110538 Approved/Revised 04-Apr-2007 Version 12
CEFTIN FOR ORAL SUSPENSION
Material
Personal Precautions Wear protective clothing and equipment consistent with the degree of
hazard.
Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or
surface drainage systems.
Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or
disposal.
Decontamination No specific decontamination or detoxification procedures have been
identified for this product. Water can be used for clean-up and
Procedures
decontamination operations.
7. HANDLING AND STORAGE
HANDLING
General Requirements No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
handling of this product.
STORAGE No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
CEFUROXIME AXETIL
INGREDIENT
3
GSK Occupational
Hazard Category
RESPIRATORY SENSITISER, SKIN
GSK Occupational 100 mcg/m3 (15 MIN STEL)
SENSITISER
Exposure Limit
Occupational Hygiene Air For advice on suitable monitoring methods, seek guidance from a qualified
environment, health and safety professional.
Monitoring Methods
ENGINEERING CONTROLS
Exposure Controls An Exposure Control Approach (ECA) is established for operations
involving this material 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.
PERSONAL PROTECTIVE EQUIPMENT
Eye Protection Wear approved safety glasses with side shields if eye contact is possible.
Respirators If respiratory protective equipment (RPE) is used, the type of RPE will
depend upon air concentrations present, required protection factor as well
as hazards, physical properties and warning properties of substances
present.
Other Equipment or Follow all local regulations if personal protective equipment (PPE) is used
in the workplace. Wear appropriate clothing to avoid skin contact. Wash
Procedures
hands and arms thoroughly after handling.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance
Granules.
Physical Form
10. STABILITY AND REACTIVITY
Stability This product is expected to be stable.
Conditions to Avoid None for normal handling of this product.
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SDS Number 110538 Approved/Revised 04-Apr-2007 Version 12
CEFTIN FOR ORAL SUSPENSION
Material
11. TOXICOLOGICAL INFORMATION
Oral Toxicity Not expected to be toxic following ingestion.
Inhalation Toxicity Can produce respiratory irritation. Adverse effects might occur following
inhalation.
Skin Effects Irritation might occur following direct contact.
Eye Effects Irritation might occur following direct contact with eyes.
Target Organ Effects No specific target organ effects have been identified.
Sensitisation Allergic skin reactions might occur following dermal exposure. Respiratory
sensitisation (allergic) reactions might occur following exposure.
Assessment based upon effects of structurally similar substances.
Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions.
Assessment based upon effects of structurally similar substances.
Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US
OSHA.
Reproductive Effects Not expected to produce adverse effects on fertility or development under
occupational exposure conditions. No adverse effects have been reported
following extensive use or exposure in humans.
Pharmacological Effects This material is an antibiotic; a cephalosporin. It is an agent intended for the
treatment of bacterial infections.
Other Adverse Effects None known for occupational exposure.
12. ECOLOGICAL INFORMATION
Summary This material contains an active pharmaceutical ingredient that has been
tested, and no 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.
ECOTOXICITY
Aquatic
Activated Sludge This material contains an active pharmaceutical ingredient that is not toxic
to activated sludge microorganisms.
Respiration
IC50: > 100 mg/l, 3 Hours, Activated sludge
Microbial Growth This material contains an active pharmaceutical ingredient that is toxic to
these microorganisms.
Inhibition
Minimum Inhibition 0.2 mg/l, , Azotobacter beijerinckii
Concentration: 0.2 mg/l, , Nostoc commune
> 1 mg/l, , Pseudomonas aeruginosa
> 1 mg/l, , Trichoderma harzianum
> 1 mg/l, , Aspergillus niger
Algal This material contains an active pharmaceutical ingredient that is not toxic
to algae.
IC50: > 91 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Static test
NOEL: 91 mg/l, 72 Hours, Selenastrum capricornutum,
green algae, Static test
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SDS Number 110538 Approved/Revised 04-Apr-2007 Version 12
CEFTIN FOR ORAL SUSPENSION
Material
Daphnid This material contains an active pharmaceutical ingredient that is not toxic
to daphnids.
EC50: > 1000 mg/l, 48 Hours, Daphnia magna, Static test
NOEL: > 1000 mg/l, 48 Hours, Daphnia magna, Static test
Fish This material contains an active pharmaceutical ingredient that is not toxic
to fish.
Adult Oncorhyncus mykiss, rainbow trout
EC50: > 120 mg/l, 96 Hours, Static test
Adult Oncorhyncus mykiss, rainbow trout
NOEL: 120 mg/l, 96 Hours, Static test
MOBILITY
Solubility This material contains an active pharmaceutical ingredient that for
environmental fate predictions has solubility in water.
Volatility This material contains an active pharmaceutical ingredient that will not
readily enter into the 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.
Henry's Law Constant Estimated at 25 C
Adsorption This material contains an active pharmaceutical ingredient that is not likely
to adsorb to soil 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.
Soil Sediment Sorption 1.09 to 1.19
(log Koc):
Partitioning This material contains an active pharmaceutical ingredient with
octanol/water partition coefficient data that suggests that for environmental
fate predictions the active pharmaceutical ingredient will not have the
tendency to distribute into fats.
PERSISTENCE/DEGRADATION
Hydrolysis This material contains an active pharmaceutical ingredient that has been
shown to be chemically unstable in water. Hydrolysis may be a significant
depletion mechanism.
Half-Life, Neutral: 30.2 Hours
Half-Life, Acidic: 299 Hours
Half-Life, Basic: 1.05 Hours
Photolysis This material contains an active pharmaceutical ingredient that is likely to
undergo photodegradation.
UV/Visible Spectrum: 290 nm
Biodegradation This material contains an active pharmaceutical ingredient that is not
readily biodegradable but is inherently biodegradable (as defined by 1993
OECD Testing Guidelines) and is not expected to persist in the
environment.
Aerobic - Ready
Percent Degradation: 42 %, 64 days, Modified Sturm test.
Percent Degradation: 28 %, 28 days, Modified Sturm test.
Aerobic - Inherent
Percent Degradation: 74 %, < 1 day, Modified Zahn-Wellens, primary
biodegradation, loss of parent., Activated sludge
Aerobic - Soil
Percent Degradation: 42.8 to 80 %, 64 days
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SDS Number 110538 Approved/Revised 04-Apr-2007 Version 12
CEFTIN FOR ORAL SUSPENSION
Material
BIOACCUMULATION This material contains an active pharmaceutical ingredient that will not have
a tendency to bioaccumulate in the food chain.
13. DISPOSAL CONSIDERATIONS
Disposal Collect for recycling or recovery if possible. The disposal method for
rejected products/returned goods must ensure that they cannot be re-sold or
Recommendations
re-used.
Regulatory Requirements Observe all local and national regulations when disposing of this product.
14. TRANSPORT INFORMATION
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.
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
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.
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.
US OSHA Standard (29 CFR Part 1910.1200)
Classification This dosage form is exempt from the requirements of the OSHA Hazard
Communication Standard.
Other US Regulations
TSCA Status Exempt
16. OTHER INFORMATION
References GSK Hazard Determination
Date Approved/Revised 04-Apr-2007 SDS Version Number 12
SDS Sections Updated
Sections Subsections
IDENTIFICATION OF SUBSTANCE / PREPARATION AND
OF COMPANY
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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