HomeMy WebLinkAboutSanofi Pasteur Fluzone Intradermal Quadrivalent SDS 29Apr2015
US - OSHA SAFETY DATA SHEET
Issue Date 13-Apr-2015
Revision Date
Version 1
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1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING
Product identifier
Product Name Fluzone® Intradermal Quadrivalent
Other means of identification
Product Information Single dose prefilled microinjection system in package of 10
Synonyms Influenza Vaccine
Recommended use of the chemical and restrictions on use
Recommended Use Active immunization for the prevention of influenza disease caused by influenza A subtype
viruses and type B viruses contained in the vaccine.
Uses advised against Not available.
Details of the supplier of the safety data sheet
Supplier Address
Sanofi Pasteur
1 Discovery Drive
Swiftwater, PA 18370
Emergency telephone number
Company Phone Number 1-800-VACCINE (1-800-822-2463)
24 Hour Emergency Phone Number 1-570-957-4400
Emergency Telephone 1-570-957-4400
2. HAZARDS IDENTIFICATION
Classification
Health Hazards
Not classified.
Physical hazards
Not classified.
OSHA Regulatory Status
This product is a vaccine that is safe for consumers when used according to the label directions. Potential hazards that may occur
if product is not used according to the consumer label are as follows throughout the sheet.
Label elements
Emergency Overview
Normal precautions common to safe manufacturing practice should be followed in handling and storage.
Appearance Clear and slightly
opalescent suspension
Physical state Liquid
Odor Not available.
Hazards not otherwise classified (HNOC)
Not classified as a hazardous substance.
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3. COMPOSITION/INFORMATION ON INGREDIENTS
Synonyms Influenza Vaccine
Chemical Name CAS No. Weight-%
Split Influenza Virus, inactivated strains N/A 0.036
Sodium phosphate-buffered isotonic sodium chloride solution N/A q.s. to 100
Note: Ingredients below reportable levels are not listed.
4. FIRST AID MEASURES
First aid measures
Eye contact In case of eye contact, immediately flush eyes with fresh water for at least 15 minutes while
holding the eyelids open. Remove contact lenses if worn. Get medical attention if irritation
persists.
Skin Contact In case of contact, remove contaminated clothing. Immediately flush skin with copious
amounts of water for at least 15 minutes. Obtain medical attention if skin reaction occurs.
Inhalation In case of inhalation, remove to fresh air. If breathing is difficult, administer oxygen. Seek
medical attention immediately.
Ingestion In case of accidental ingestion, wash out mouth with copious amounts of water. Seek
medical attention if needed. Do not induce vomiting unless directed by medical personnel.
Never give anything by mouth to an unconscious person.
Self-protection of the first aider Do not use mouth-to-mouth method if victim ingested or inhaled the substance; give
artificial respiration with the aid of a pocket mask equipped with a one-way valve or other
proper respiratory medical device.
Most important symptoms and effects, both acute and delayed
Symptoms Common effects of the vaccine include the following: pain, pruritus, erythema, swelling, and
induration of the injection site; myalgia; headache; malaise; shivering.
Indication of any immediate medical attention and special treatment needed
Note to physicians Treat symptomatically.
5. FIRE-FIGHTING MEASURES
Suitable extinguishing media
Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Unsuitable extinguishing media None known.
Specific hazards arising from the chemical
Not available.
Hazardous combustion products Not available.
Explosion data
Sensitivity to Mechanical Impact Not available.
Sensitivity to Static Discharge None known.
Protective equipment and precautions for firefighters
As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full
protective gear.
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6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protective equipment and emergency procedures
Personal precautions Wear appropriate personal protective equipment (see Section 8).
Environmental precautions
Environmental precautions See Section 12 for additional ecological information.
Methods and material for containment and cleaning up
Methods for containment Prevent further leakage or spillage if safe to do so.
Methods for cleaning up Wipe up with absorbent material (e.g. cloth) for disposal. Area where spill occurred can be
cleaned with the regular cleaning materials designated for the area.
7. HANDLING AND STORAGE
Precautions for safe handling
Advice on safe handling Handle in accordance with good industrial hygiene and safety practice.
Conditions for safe storage, including any incompatibilities
Storage Conditions Store at 2° to 8°C (35° to 46°F). Do not freeze.
Incompatible materials Not available.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Control parameters
Exposure Guidelines This product, as supplied, does not contain any hazardous materials with Occupational
Exposure Limits (OEL) established by the region specific regulatory bodies.
Appropriate engineering controls
Engineering Controls Used as supplied, no special engineering controls are needed when administering the
vaccine.
Individual protection measures, such as personal protective equipment
Eye/face protection In laboratory or industrial settings, safety glasses with side shields are recommended.
Skin and body protection In laboratory or industrial settings, gloves and lab coats are recommended.
Respiratory protection Used as supplied, general room ventilation is acceptable and no special respiratory
protection is needed when administering the vaccine.
General Hygiene Considerations Always observe good personal hygiene measures, such as washing after handling the
material and before eating, drinking, and/or smoking. Routinely wash work clothing and
protective equipment.
9. PHYSICAL AND CHEMICAL PROPERTIES
Information on basic physical and chemical properties
Physical state Liquid
Appearance Clear and slightly opalescent
suspension
Odor Not available.
Color Slightly opalescent. Odor threshold Not available.
Property Values
Remarks • Method
pH Not available.
Melting point/freezing point Not available.
Boiling point / boiling range Not available.
Flash point Not available.
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Evaporation rate Not available.
Flammability (solid, gas) Not available.
Flammability Limit in Air
Upper flammability limit: Not available.
Lower flammability limit: Not available.
Vapor pressure Not available.
Vapor density Not available.
Specific Gravity Not available.
Water solubility Not available.
Solubility in other solvents Not available.
Partition coefficient Not available.
Autoignition temperature Not available.
Decomposition temperature Not available.
Kinematic viscosity Not available.
Dynamic viscosity Not available.
Explosive properties Not available.
Oxidizing properties Not available.
Other Information
Softening point Not available.
Molecular weight Not available.
VOC Content (%) Not available.
Density Not available.
Bulk density Not available.
10. STABILITY AND REACTIVITY
Reactivity
Not reactive under normal conditions.
Chemical stability
Stable under normal conditions.
Possibility of Hazardous Reactions
None under normal handling.
Hazardous polymerization Hazardous polymerization does not occur.
Conditions to avoid
Not available.
Incompatible materials
Not available.
Hazardous Decomposition Products
None under normal use conditions.
11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Product Information No data available.
Inhalation No impact known or expected under normal use.
Eye contact No impact known or expected under normal use.
Skin Contact No impact known or expected under normal use.
Ingestion No impact known or expected under normal use.
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Information on toxicological effects
Symptoms Common effects of the vaccine include the following: pain, pruritus, erythema, swelling, and
induration of the injection site; myalgia; headache; malaise; shivering.
Delayed and immediate effects as well as chronic effects from short and long-term exposure
Skin corrosion/irritation Not available.
Serious eye damage/eye irritation Not available.
Irritation Not available.
Corrosivity Not available.
Sensitization Not available.
Germ cell mutagenicity Not available.
Carcinogenicity Not available.
Reproductive toxicity Pregnancy Category B: The developmental and reproductive toxicity study performed with
the trivalent formulation of Fluzone Intradermal is relevant to Fluzone Intradermal
Quadrivalent because both vaccines share the same manufacturing process and route of
administration. The study, in which the trivalent formulation of Fluzone Intradermal (27 mcg)
was administered to female rabbits at a dose approximately 20 times the human dose (on a
mg/kg basis), revealed no evidence of impaired female fertility or harm to the fetus. There
are, however, no adequate and well-controlled studies in pregnant women. Because animal
reproduction studies are not always predictive of human response, Fluzone Intradermal
Quadrivalent should be used during pregnancy only if clearly needed.
It is not known whether Fluzone Intradermal Quadrivalent is excreted in human milk.
Because many drugs are excreted in human milk, the decision to give Fluzone Intradermal
Quadrivalent to a nursing woman should be based on careful consideration of the potential
benefits and risks. Developmental Toxicity Not available.
Teratogenicity Not available.
STOT - single exposure Not classified.
STOT - repeated exposure Not classified.
Chronic toxicity Not available.
Subchronic toxicity Not available.
Target Organ Effects Not available.
Neurological effects Not available.
Other adverse effects Not available.
Aspiration hazard Not available.
12. ECOLOGICAL INFORMATION
Ecotoxicity
Not available.
Persistence and degradability
Not available.
Bioaccumulation
Not available.
Mobility
Not available.
Other adverse effects Not available.
13. DISPOSAL CONSIDERATIONS
Waste treatment methods
Disposal of wastes Disposal should be in accordance with applicable regional, national and local laws and
regulations.
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Contaminated packaging Disposal should be in accordance with applicable regional, national and local laws and
regulations.
US EPA Waste Number Not applicable.
California Hazardous Waste Codes Not applicable.
14. TRANSPORT INFORMATION
DOT Not regulated.
TDG Not regulated.
MEX Not regulated.
ICAO (air) Not regulated.
IATA Not regulated.
IMDG Not regulated.
RID Not regulated.
ADR Not regulated.
ADN Not regulated.
15. REGULATORY INFORMATION
US Federal Regulations
SARA 313
Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any
chemicals which are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372.
SARA 311/312 Hazard Categories
Acute health hazard No
Chronic Health Hazard No
Fire hazard No
Sudden release of pressure hazard No
Reactive Hazard No
CWA (Clean Water Act)
This product does not contain any substances regulated as pollutants pursuant to the Clean Water Act (40 CFR 122.21 and 40
CFR 122.42).
CERCLA
This material, as supplied, does not contain any substances regulated as hazardous substances under the Comprehensive
Environmental Response Compensation and Liability Act (CERCLA) (40 CFR 302) or the Superfund Amendments and
Reauthorization Act (SARA) (40 CFR 355).
US State Regulations
California Proposition 65
This product does not contain any Proposition 65 chemicals.
U.S. State Right-to-Know Regulations
This product does not contain any substances regulated by state right-to-know regulations.
U.S. EPA Label Information
EPA Pesticide Registration Number Not applicable.
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16. OTHER INFORMATION
Revision Date
Revision Note
Not available.
Disclaimer
Sanofi Pasteur considers that the information contained in this Safety Data Sheet is accurate, and while it is provided in
good faith, it is without warranty of any kind, expressed or implied. The information contained herein is designated only
as guidance for safe handling, storage and use of the substance and is not a specification nor does it guarantee any
specific properties. Only competent personnel, within a controlled environment should handle all chemicals. Sanofi
Pasteur cannot be held liable for any loss, injury or damage from contact with the product.
End of Safety Data Sheet