SDS Number 4244 Approved/Revised 16-Jul-2008 Version 13
FLOXAPEN SYRUP
Material
SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE
COMPANY/UNDERTAKING
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Material FLOXAPEN SYRUP
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FLOXAPEN SYRUP 125 MG /5 ML * FLOXAPEN SYRUP 250 MG/5 ML * FLOPEN
Synonym(s)
SUSPENSION 125 MG * FLOPEN SUSPENSION 250 MG * STAPHYPEN SYRUP *
FLOXAPEN LIQUID * STAPHYLEX TROCKENSAFT 5 G/100 ML * FLUCLOXACILLIN
MAGNESIUM, 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
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2. COMPOSITION / INFORMATION ON INGREDIENTS
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Ingredients CAS # Percent EC-No.
FLUCLOXACILLIN MAGNESIUM 58486-36-5 4 to 10
NON-HAZARDOUS INGREDIENTS Unassigned 90 to 96
3. HAZARDS IDENTIFICATION
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Assume that this product is capable of sustaining combustion.
Fire and Explosion
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Exposure might occur via skin; eyes; ingestion; inhalation.
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.
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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SDS Number 4244 Approved/Revised 16-Jul-2008 Version 13
FLOXAPEN SYRUP
Material
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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 penicillin 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 penicillin 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, 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
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 4244 Approved/Revised 16-Jul-2008 Version 13
FLOXAPEN SYRUP
Material
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
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FLUCLOXACILLIN MAGNESIUM
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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Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after
Other Equipment or
handling.
Procedures
9. PHYSICAL AND CHEMICAL PROPERTIES
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Appearance
White.
Colour
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Free flowing 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 a penicillin; an antibiotic.
Pharmacological Effects
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Routes of Exposure
Not expected to be toxic following ingestion.
Oral Toxicity
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Adverse effects might occur following inhalation.
Inhalation Toxicity
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Irritation might occur following direct contact.
Skin Effects
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Minor 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.
12. ECOLOGICAL INFORMATION
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No information is available about the potential of this product to produce adverse
Summary
environmental effects. Local regulations and procedures should be consulted prior to
environmental release.
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SDS Number 4244 Approved/Revised 16-Jul-2008 Version 13
FLOXAPEN SYRUP
Material
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PERSISTENCE/DEGRADATION
Penicillins are generally susceptible to degradation by a number of micro-organisms found in
Biodegradation
wastewater treatment plants and the general environment. Resulting degradation products
are readily mineralised by environmental micro-organisms.
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.
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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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13
SDS Version Number
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SDS Sections Updated
Sections Subsections
COMPOSITION / INFORMATION ON INGREDIENTS
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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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