SAFETY DATA SHEET

1. Identification
Product identifier RABIPUR RABIES VACCINE
Other means of identification
Synonyms RABAVERT VACCINE, SUSPENSION FOR INJECTION (US) * RABIPUR (LYOPHILISATE),
RABIES VACCINE, SUSPENSION FOR INJECTION (EU) * RABAVERT RABIES VACCINE *
PURIFIED CHICK EMBRYO CELL VACCINE (PCECV)
Recommended use Medicinal Product.

This safety data sheet is written to provide health, safety and environmental information for people
handling this formulated product in the workplace. It is not intended to provide information relevant
to medicinal use of the product. In this instance patients should consult prescribing
information/package insert/product label or consult their pharmacist or physician. For health and
safety information for individual ingredients used during manufacturing, refer to the appropriate
safety data sheet for each ingredient.
Recommended restrictions No other uses are advised.
Manufacturer/Importer/Supplier/Distributor information
Manufacturer
GlaxoSmithKline US
5 Moore Drive
Research Triangle Park, NC 27709 USA
US General Information (normal business hours): +1-888-825-5249

Email Address: [email protected]

Website: www.gsk.com

EMERGENCY PHONE NUMBERS -

TRANSPORT EMERGENCIES:
US / International toll call +1 703 527 3887
available 24 hrs/7 days; multi-language response

2. Hazard(s) identification
Classified hazards
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Label elements
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
Hazard(s) not otherwise classified (HNOC)
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.

3. Composition/information on ingredients
Mixtures
Chemical name Common name and synonyms CAS number %
INACTIVATED RABIES VIRUS Unassigned < 75

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 Chemical name Common name and synonyms CAS number %
ETHYLENEDIAMINETETRAACETI (ETHYLENEDINITRILO)TETRA-ACETIC 6381-92-6 < = 1.0
C ACID, DISODIUM SALT, ACID, DISODIUM SALT, DIHYDRATE
DIHYDRATE DISODIUM DIHYDROGEN
ETHYLENEDIAMINETETRAACETATE
DIHYDRATE
DISODIUM EDTA DIHYDRATE
DISODIUM
ETHYLENEDIAMINETETRAACETATE
DISODIUM
ETHYLENEDIAMINETETRAACETATE
DIHYDRATE
EDETATE DISODIUM
EDTA, DISODIUM DIHYDRATE
ETHYLENEDIAMINE TETRAACETATE
ACID DISODIUM SALT, DIHYDRATE
ETHYLENEDIAMINETETRAACETIC ACID
DISODIUM SALT DIHYDRATE
RTECS AH4410000
CHLORTETRACYCLINE METHACYCLINE; ITS SALTS; ITS ESTERS; 57-62-5 < = 0.10
THEIR SALTS
NEOMYCIN SULFATE NEOMYCIN, SULFATE (SALT) 1405-10-3 < = 0.10
NEOMYCIN SULPHATE
MYCERIN SULPHATE
242 (GW ACN)
MYCIGUENT
NEOMIX
NEOMYCIN SULFATE USP POWDER 50/50
Other components below reportable levels 25 - < 30
*Designates that a specific chemical identity and/or percentage of composition has been withheld as a trade secret.

4. First-aid measures
Inhalation Move to fresh air. If breathing is difficult, trained personnel should give oxygen. Call a physician if
symptoms develop or persist. Under normal conditions of intended use, this material is not
expected to be an inhalation hazard.
Skin contact Immediately flush skin with plenty of water. Take off contaminated clothing and wash before reuse.
Get medical attention if symptoms occur.
Eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Ingestion If swallowed, rinse mouth with water (only if the person is conscious). If ingestion of a large
amount does occur, call a poison control center immediately. Do not induce vomiting without
advice from poison control center.
Most important None known.
symptoms/effects, acute and
delayed
Indication of immediate No specific antidotes are recommended. Treat according to locally accepted protocols. For
medical attention and special additional guidance, refer to the current prescribing information or to the local poison control
treatment needed information center.
General information In the case of accident or if you feel unwell, seek medical advice immediately (show the label
where possible). Ensure that medical personnel are aware of the material(s) involved, and take
precautions to protect themselves.

5. Fire-fighting measures
Suitable extinguishing media Alcohol resistant foam. Water. Foam. Dry chemical powder. Carbon dioxide (CO2).
Unsuitable extinguishing None known.
media
Specific hazards arising from During fire, gases hazardous to health may be formed.
the chemical
Special protective equipment Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
and precautions for firefighters
Fire fighting Move containers from fire area if you can do so without risk.
equipment/instructions
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.

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General fire hazards No unusual fire or explosion hazards noted.

6. Accidental release measures

Personal precautions, Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Wear
protective equipment and appropriate protective equipment and clothing during clean-up. Do not touch damaged containers
emergency procedures or spilled material unless wearing appropriate protective clothing. Ensure adequate ventilation.
Local authorities should be advised if significant spillages cannot be contained. For personal
protection, see section 8 of the SDS.
Methods and materials for Stop the flow of material, if this is without risk. Prevent entry into waterways, sewer, basements or
containment and cleaning up confined areas. Following product recovery, flush area with water.
Environmental precautions Avoid discharge into drains, water courses or onto the ground.

7. Handling and storage

Precautions for safe handling Avoid prolonged exposure. Observe good industrial hygiene practices.
Conditions for safe storage, Store in original tightly closed container. Store in a well-ventilated place. Store at 2 to 8 °C (36 to
including any incompatibilities 46 °F). Do not freeze. To maintain product quality, do not store in heat or direct sunlight. Dispose
of properly if frozen. Store away from incompatible materials (see Section 10 of the SDS).

8. Exposure controls/personal protection

Occupational exposure limits
GSK
Components Type Value Note

ETHYLENEDIAMINETETR 8 HR TWA 3000 mcg/m3

AACETIC ACID, DISODIUM
SALT, DIHYDRATE (CAS
6381-92-6)
OHC 1
NEOMYCIN SULFATE 8 HR TWA 2000 mcg/m3
(CAS 1405-10-3)
OHC 1 SKIN SENSITISER
1 REPRODUCTIVE
HAZARD
Biological limit values No biological exposure limits noted for the ingredient(s).
Exposure guidelines
Appropriate engineering General ventilation normally adequate.
controls
Individual protection measures, such as personal protective equipment
Eye/face protection Not normally needed. If contact is likely, safety glasses with side shields are recommended.

Skin protection
Hand protection Not normally needed. For prolonged or repeated skin contact use suitable protective gloves.
Other Not normally needed. Wear suitable protective clothing as protection against splashing or
contamination.
Respiratory protection No personal respiratory protective equipment normally required. Use a NIOSH/MSHA approved
respirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits.
Thermal hazards Wear appropriate thermal protective clothing, when necessary.
General hygiene Always observe good personal hygiene measures, such as washing after handling the material
considerations and before eating, drinking, and/or smoking. Routinely wash work clothing and protective
equipment to remove contaminants. For advice on suitable monitoring methods, seek guidance
from a qualified environment, health and safety professional.

9. Physical and chemical properties

Appearance
Physical state Solid.
Form Vial. Freeze dried powder. (Lyophilized).
and
Vial. Diluent.
Color White
Odor Odourless.

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Odor threshold Not available.
pH Not available.
Melting point/freezing point 32 °F (0 °C)
Initial boiling point and boiling 212 °F (100 °C)
range
Flash point Not available.
Evaporation rate Not available.
Flammability (solid, gas) Not available.
Upper/lower flammability or explosive limits
Flammability limit - lower Not available.
(%)
Flammability limit - upper Not available.
(%)
Explosive limit - lower (%) Not available.
Explosive limit - upper (%) Not available.
Vapor pressure Not available.
Vapor density Not available.
Relative density Not available.
Solubility(ies)
Solubility (water) Not available.
Partition coefficient Not available.
(n-octanol/water)
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
Other information
Specific gravity 1

10. Stability and reactivity

Reactivity The product is stable and non-reactive under normal conditions of use, storage and transport.
Chemical stability Material is stable under normal conditions.
Possibility of hazardous No dangerous reaction known under conditions of normal use.
reactions
Conditions to avoid Do not freeze. Contact with incompatible materials.
Incompatible materials Strong oxidizing agents.
Hazardous decomposition None known. Irritating and/or toxic fumes and gases may be emitted upon the product's
products decomposition.

11. Toxicological information

Information on likely routes of exposure
Inhalation Under normal conditions of intended use, this material is not expected to be an inhalation hazard.
NEOMYCIN SULFATE Literature search
Result: May cause irritation
Skin contact Health injuries are not known or expected under normal use.
Eye contact Health injuries are not known or expected under normal use.
Ingestion Health injuries are not known or expected under normal use. Expected to be a low ingestion
hazard. However, ingestion is not likely to be a primary route of occupational exposure.
Symptoms related to the None known.
physical, chemical and
toxicological characteristics
Information on toxicological effects
Acute toxicity Health injuries are not known or expected under normal use.

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Components Species Test Results
NEOMYCIN SULFATE (CAS 1405-10-3)
Acute
Oral
LD50 Mouse > 8000 mg/kg

* Estimates for product may be based on additional component data not shown.
Skin corrosion/irritation Health injuries are not known or expected under normal use.
Corrosivity
NEOMYCIN SULFATE Literature search
Result: Irritant
Serious eye damage/eye Health injuries are not known or expected under normal use.
irritation
Eye
NEOMYCIN SULFATE Literature search
Result: Irritant
Respiratory or skin sensitization
Respiratory sensitization Not established.
NEOMYCIN SULFATE Literature search
Result: Positive
Skin sensitization This product is not expected to cause skin sensitization.
Sensitization
NEOMYCIN SULFATE Literature search
Result: Positive
Germ cell mutagenicity No data available to indicate product or any components present at greater than 0.1% are
mutagenic or genotoxic.
Carcinogenicity Not classifiable as to carcinogenicity to humans.
NEOMYCIN SULFATE 25 mg/kg/day, Auditory toxicity, no evidence of carcinogenicity.
Species: Rat
Observation Period: 104 weeks
IARC Monographs. Overall Evaluation of Carcinogenicity
Not available.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not listed.
US. National Toxicology Program (NTP) Report on Carcinogens
Not available.
Reproductive toxicity Components in this product have been shown to cause birth defects and reproductive disorders in
laboratory animals. These effects are linked only to high doses of this substance; low doses did
not produce this adverse effect.
Reproductivity
NEOMYCIN SULFATE 100 mg/kg/day Embryo-foetal development, Intra-muscular
administration.
Result: Auditory toxicity in offspring.
Species: Rat
Notes: Shepherd's Catalogue of Teratogenic Agents.
25 mg/kg/day 3-generation study, Dietary study.
Result: NOAEL (maximum dose)
Species: Rat
Notes: WHO Food Additive Series
25 mg/kg/day, Dietary study.
Result: No adverse foetal effects observed.
Species: Rat
Notes: WHO Food Additive Series
4 g/l Embryo-foetal development, Administered in drinking
water.
Result: No malformations.
Species: Mouse
Notes: Shepherd's Catalogue of Teratogenic Agents.

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 Reproductivity
NEOMYCIN SULFATE Embryo-foetal development
Result: No malformations.
Species: Rabbit
Notes: Reprotox
Specific target organ toxicity - None known.
single exposure
Specific target organ toxicity - None known.
repeated exposure
NEOMYCIN SULFATE Organ: Auditory system, kidneys.
Aspiration hazard Not likely, due to the form of the product.
Chronic effects None known.
Further information Caution - Pharmaceutical agent. Occupational exposure to the substance or mixture may cause
adverse effects.

12. Ecological information

Ecotoxicity The product is not classified as environmentally hazardous. However, this does not exclude the
possibility that large or frequent spills can have a harmful or damaging effect on the environment.
Components Species Test Results
ETHYLENEDIAMINETETRAACETIC ACID, DISODIUM SALT, DIHYDRATE (CAS 6381-92-6)
Aquatic
Acute
Crustacea EC50 Water flea (Daphnia magna) 21.6 mg/l, 48 hours Static test
NOEC Water flea (Daphnia magna) 4.1 mg/l, 48 hours Static test
Fish EC50 Bluegill sunfish (Adult Lepomis 52.5 mg/l, 96 hours Static test
macrochirus)
Channel catfish (Adult Ictalurus 164 mg/l, 96 hours Static test
punctatus)
Fathead minnow (Adult Pimephales 75.9 mg/l, 96 hours Static test
promelas)
NEOMYCIN SULFATE (CAS 1405-10-3)
Aquatic
Acute
Other MIC Bacteria 0.12 mg/l

* Estimates for product may be based on additional component data not shown.
Persistence and degradability
Biodegradability
Percent degradation (Aerobic biodegradation-inherent)
ETHYLENEDIAMINETETRAACETIC ACID, DISODIUM 37 %, 14 days Zahn-Wellens, Activated sludge
SALT, DIHYDRATE
Percent degradation (Aerobic biodegradation-ready)
ETHYLENEDIAMINETETRAACETIC ACID, DISODIUM 28 %, 28 days Sturm test
SALT, DIHYDRATE
Percent degradation (Aerobic biodegradation-soil)
ETHYLENEDIAMINETETRAACETIC ACID, DISODIUM 13 - 45 %, 15 weeks
SALT, DIHYDRATE
Bioaccumulative potential
Bioconcentration factor (BCF)
ETHYLENEDIAMINETETRAACETIC ACID, DISODIUM 0.8 - 1.8 Measured, Lepomis macrochirus, bluegill sunfish
SALT, DIHYDRATE
Mobility in soil Not available.
Mobility in general Not available.
Other adverse effects Not available.

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13. Disposal considerations
Disposal instructions Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Do not
discharge into drains, water courses or onto the ground. Dispose in accordance with all applicable
regulations.
Local disposal regulations Dispose in accordance with all applicable regulations.
Hazardous waste code The waste code should be assigned in discussion between the user, the producer and the waste
disposal company.
Waste from residues / unused Dispose of in accordance with local regulations. Empty containers or liners may retain some
products product residues. This material and its container must be disposed of in a safe manner (see:
Disposal instructions). Avoid discharge into water courses or onto the ground.
Contaminated packaging Since emptied containers may retain product residue, follow label warnings even after container is
emptied. Empty containers should be taken to an approved waste handling site for recycling or
disposal.

14. Transport information

DOT
Not regulated as a dangerous good.
Not available.
IATA
Not regulated as dangerous goods.
IMDG
Not regulated as dangerous goods.
Transport in bulk according to Not established.
Annex II of MARPOL 73/78 and
the IBC Code

15. Regulatory information

US federal regulations
TSCA Section 12(b) Export Notification (40 CFR 707, Subpt. D)
Not regulated.
CERCLA Hazardous Substance List (40 CFR 302.4)
Not listed.
SARA 304 Emergency release notification
Not regulated.
OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not listed.
Superfund Amendments and Reauthorization Act of 1986 (SARA)
Hazard categories Immediate Hazard - Yes
Delayed Hazard - Yes
Fire Hazard - Yes
Pressure Hazard - No
Reactivity Hazard - No
SARA 302 Extremely hazardous substance
Not listed.
SARA 311/312 Hazardous No
chemical
SARA 313 (TRI reporting)
Not regulated.

Other federal regulations

Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
Not regulated.
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Safe Drinking Water Act Not regulated.
(SDWA)

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US state regulations
US. California Controlled Substances. CA Department of Justice (California Health and Safety Code Section 11100)
Not listed.
US. Massachusetts RTK - Substance List
Not regulated.
US. New Jersey Worker and Community Right-to-Know Act
Not listed.
US. Pennsylvania Worker and Community Right-to-Know Law
Not listed.
US. Rhode Island RTK
Not regulated.
US. California Proposition 65
WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive
harm.
US - California Proposition 65 - CRT: Listed date/Developmental toxin
NEOMYCIN SULFATE (CAS 1405-10-3) Listed: October 1, 1992
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
Australia Australian Inventory of Chemical Substances (AICS) No
Canada Domestic Substances List (DSL) No
Canada Non-Domestic Substances List (NDSL) No
China Inventory of Existing Chemical Substances in China (IECSC) No
Europe European Inventory of Existing Commercial Chemical No
Substances (EINECS)
Europe European List of Notified Chemical Substances (ELINCS) No
Japan Inventory of Existing and New Chemical Substances (ENCS) No
Korea Existing Chemicals List (ECL) No
New Zealand New Zealand Inventory No
Philippines Philippine Inventory of Chemicals and Chemical Substances No
(PICCS)
United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory No
*A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s)
A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing
country(s).

16. Other information, including date of preparation or last revision

Issue date 06-02-2015
Revision date 10-12-2015
Version # 02
Further information Refer to NFPA 654, Standard for the Prevention of Fire and Dust Explosions from the
Manufacturing, Processing, and Handling of Combustible Particulate Solids, for safe handling.
HMIS® is a registered trade and service mark of the NPCA.
HMIS® ratings Health: 1*
Flammability: 1
Physical hazard: 0
NFPA ratings Health: 1
Flammability: 1
Instability: 0
References GSK Hazard Determination
Disclaimer 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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Revision information Product and Company Identification: Synonyms
Hazard(s) identification: Hazard(s) not otherwise classified (HNOC)
Fire-fighting measures: General fire hazards
Handling and storage: Conditions for safe storage, including any incompatibilities
Physical & Chemical Properties: Multiple Properties
Physical and chemical properties: Form
Stability and reactivity: Conditions to avoid
Toxicological information: Further information
Ecological information: Ecotoxicity

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