HomeMy WebLinkAboutGSK Havrix Junior (Hep A - Peds)SAFETY DATA SHEET
1. Identification
Product identifier HAVRIX JUNIOR
Other means of identification Not available.
Synonym(s)HAVRIX PAEDIATRIC INJECTION 720 EL U/0.5 ML * HAVRIX PAEDIATRIC INJECTION 360 EL
U/0.5 ML * HAVRIX 720 * HAVRIX 360 * HAVRIX JUNIOR * HAVRIX JUNIOR MONODOSE * NDC
NO. 58160-825-11 * NDC NO. 58160-825-46 * HAV VACCINE * HEPATOVIRUS VACCINE *
HEPATITIS A (INACTIVATED) VACCINE (ADSORBED)
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: msds@gsk.com
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
CAS number %Chemical name Common name and synonyms
COMMON SALT
HALITE
ROCK SALT
SODIUM MONOCHLORIDE
SALT
SEA SALT
TABLE SALT
SODIUM CHLORIDE (NaCl)
ClNa
BULK INDUSTRIAL CRUDE SOLAR
SALT, WHITE CRYSTALS, SOLAR
OHS21105
RTECS VZ4725000
329 (GW ACN)
7647-14-5SODIUM CHLORIDE 1
HEPATITIS A VIRUS INACTIVATED UnassignedHEPATITIS A VIRUS
INACTIVATED
<1
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SDS US
CAS number %Chemical name Common name and synonyms
AF 260
ALCOA 331
ALCOA C 30BF
ALUMIGEL
ALUMINA HYDRATED
ALUMINA TRIHYDRATE
ALPHA-ALUMINA TRIHYDRATE
ALUMINIC ACID
ALUMINIUM HYDROXIDE
ALUMINUM HYDRATE
ALUMINUM(III) HYDROXIDE
ALUMINUM HYDROXIDE GEL
ALUMINUM OXIDE TRIHYDRATE
ALUMINUM TRIHYDRATE
ALUMINUM TRIHYDROXIDE
ALUSAL
AMBEROL ST 140F
AMPHOJEL
BACO AF 260
BRITISH ALUMINUM AF 260
C 31
C 33
C 31C
C 4D
C 31F
C-31-F
C.I. 77002
GHA 331
GHA 332
H 46
HIGILITE
HIGILITE H 32
HIGILITE H 42
HIGILITE H 31S
HYCHOL 705
HYDRAL 705
HYDRAL 710
HYDRATED ALUMINA
LIQUIGEL
MARTINAL
P 30BF
PGA
TRIHYDRATED ALUMINA
TRIHYDROXYALUMINUM
21645-51-2ALUMINIUM HYDROXIDE 0.1
POTASSIUM CHLORIDE (KCL)
POTASSIUM MONOCHLORIDE
SUPER K (SALT)
POTASSIUM MURIATE
7447-40-7POTASSIUM CHLORIDE
Other components below reportable levels 98.2
0.1
*Designates that a specific chemical identity and/or percentage of composition has been withheld as a trade secret.
4. First-aid measures
Inhalation Under normal conditions of intended use, this material is not expected to be an inhalation hazard.
Skin contact Immediately flush with plenty of water for at least 15 minutes while removing contaminated clothing
and shoes. Get medical attention if irritation develops and persists.
Eye contact Rinse immediately with plenty of water for at least 15 minutes. Get medical attention if irritation
develops and persists.
Ingestion Rinse mouth thoroughly. Get medical advice/attention if you feel unwell. Do not induce vomiting.
Most important
symptoms/effects, acute and
delayed
None known.
Indication of immediate
medical attention and special
treatment needed
No specific antidotes are recommended. Treat according to locally accepted protocols. For
additional guidance, refer to the current prescribing information or to the local poison control
information centre.
General information Pre-placement and periodic health surveillance is not usually indicated. The final determination of
the need for health surveillance should be determined by local risk assessment.
5. Fire-fighting measures
Suitable extinguishing media Foam. Dry chemical powder. Carbon dioxide (CO2).
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Unsuitable extinguishing
media
None known.
Specific hazards arising from
the chemical
During fire, gases hazardous to health may be formed.
Special protective equipment
and precautions for firefighters
Self-contained breathing apparatus and full protective clothing must be worn in case of fire.
Fire-fighting
equipment/instructions
Move containers from fire area if you can do so without risk.
Specific methods Use standard firefighting procedures and consider the hazards of other involved materials.
General fire hazards This product is expected to be non-combustible.
6. Accidental release measures
Personal precautions,
protective equipment and
emergency procedures
Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Keep out of
low areas. Do not touch damaged containers or spilled material unless wearing appropriate
protective clothing. For personal protection, see section 8 of the SDS.
Methods and materials for
containment and cleaning up
Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this is
possible. Cover with plastic sheet to prevent spreading. Absorb in vermiculite, dry sand or earth
and place into containers. Prevent entry into waterways, sewer, basements or confined areas.
Following product recovery, flush area with water.
Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to
remove residual contamination.
Never return spills to original containers for re-use. For waste disposal, see section 13 of the SDS.
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,
including any incompatibilities
Store in original tightly closed container. Store away from incompatible materials (see Section 10
of the SDS).
8. Exposure controls/personal protection
Occupational exposure limits
GSK
ValueComponents Type
8 HR TWA 5000 mcg/m3POTASSIUM CHLORIDE
(CAS 7447-40-7)
OHC 1
US. ACGIH Threshold Limit Values
ValueComponents FormType
TWA 1 mg/m3 Respirable fraction.ALUMINIUM HYDROXIDE
(CAS 21645-51-2)
Biological limit values No biological exposure limits noted for the ingredient(s).
Appropriate engineering
controls
No particular ventilation requirements.
Individual protection measures, such as personal protective equipment
Eye/face protection Not normally needed.
Hand protection Not normally needed.
Other Not normally needed.
Respiratory protection No personal respiratory protective equipment normally required.
Thermal hazards Wear appropriate thermal protective clothing, when necessary.
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 to remove contaminants.
9. Physical and chemical properties
Appearance
Physical state Liquid.
Form Vial.
or
Pre-filled syringe.
Color Not available.
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Odor Not available.
Odor threshold Not available.
pH Not available.
Melting point/freezing point Not available.
Initial boiling point and boiling
range
Not available.
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
(n-octanol/water)
Not available.
Auto-ignition temperature Not available.
Decomposition temperature Not available.
Viscosity Not available.
10. Stability and reactivity
Reactivity Not available.
Chemical stability Material is stable under normal conditions.
Possibility of hazardous
reactions
No dangerous reaction known under conditions of normal use.
Conditions to avoid Contact with incompatible materials.
Incompatible materials Strong oxidizing agents.
Hazardous decomposition
products
Irritating and/or toxic fumes and gases may be emitted upon the products decomposition.
11. Toxicological information
Information on likely routes of exposure
Ingestion Expected to be a low ingestion hazard.
Inhalation Under normal conditions of intended use, this material is not expected to be an inhalation hazard.
Skin contact Health injuries are not known or expected under normal use.
Eye contact Health injuries are not known or expected under normal use.
Symptoms related to the
physical, chemical and
toxicological characteristics
None known.
Information on toxicological effects
Acute toxicity Health injuries are not known or expected under normal use.
Test ResultsComponents Species
POTASSIUM CHLORIDE (CAS 7447-40-7)
LD50 Rat
Oral
Acute
2600 mg/kg
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SDS US
Test ResultsComponents Species
SODIUM CHLORIDE (CAS 7647-14-5)
LD50 Rat
Oral
Acute
3000 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.
Serious eye damage/eye
irritation
Health injuries are not known or expected under normal use.
Respiratory or skin sensitization
Respiratory sensitization Due to partial or complete lack of data the classification is not possible.
Skin sensitization This product is not expected to cause skin sensitization.
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.
US. OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050)
Not listed.
Reproductive toxicity Contains no ingredient listed as toxic to reproduction
Specific target organ toxicity -
single exposure
None known.
Specific target organ toxicity -
repeated exposure
None known.
Aspiration hazard Not likely, due to the form of the product.
Further information Caution - Pharmaceutical agent.
12. Ecological information
Ecotoxicity Not expected to be harmful to aquatic organisms.
Components Test ResultsSpecies
ALUMINIUM HYDROXIDE (CAS 21645-51-2)
Aquatic
Acute
NOECAlgae > 100 mg/l, 72 hoursGreen algae (Selenastrum
capricornutum)
NOECCrustacea > 100 mg/l, 48 hoursWater flea (Daphnia magna)
NOECFish > 100 mg/l, 96 hours Static renewal testBrown trout (Adult Salmo trutta)
POTASSIUM CHLORIDE (CAS 7447-40-7)
Aquatic
Acute
NOECAlgae 600 mg/l, 4 monthsGreen algae (Chlorella vulgaris)
EC50Crustacea 83 mg/l, 48 hours Static testWater flea (Daphnia magna)
EC50Fish 951 mg/l, 96 hours Static testBluegill sunfish (Adult Lepomis
macrochirus)
720 mg/l, 48 hours Static testChannel catfish (Adult Ictalurus
punctatus)
880 mg/l, 96 hours Static testFathead minnow (Adult Pimephales
promelas)
435 mg/l, 96 hours Static testMosquito fish (Adult Gambusia affinis)
SODIUM CHLORIDE (CAS 7647-14-5)
Aquatic
Acute
EC50Algae 2430 mg/l, 5 daysAlgae (Nitscheria linearis)
EC50Crustacea 3310 mg/l, 48 hours Static testWater flea (Daphnia magna)
EC50Fish 1295 mg/l, 96 hours Static testBluegill sunfish (Juvenile Lepomis
macrochirus)
6390 mg/l, 96 hours Static testFathead minnow (Juvenile Pimephales
promelas)
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Components Test ResultsSpecies
7000 mg/l, 96 hoursGoldfish (Adult Carassius auratus)
* Estimates for product may be based on additional component data not shown.
17550 mg/l, 96 hours Static testMosquito fish (Adult Gambusia affinis)
Persistence and degradability No data is available on the degradability of this product.
Bioaccumulative potential No data available.
Mobility in soil No data available.
Other adverse effects Not available.
13. Disposal considerations
Disposal instructions Collect and reclaim or dispose in sealed containers at licensed waste disposal site.
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
products
Dispose of in accordance with local regulations. Empty containers or liners may retain some
product residues. This material and its container must be disposed of in a safe manner (see:
Disposal instructions).
Contaminated packaging Empty containers should be taken to an approved waste handling site for recycling or disposal.
Since emptied containers may retain product residue, follow label warnings even after container is
emptied.
14. Transport information
DOT
Not regulated as a dangerous good.
IATA
Not regulated as dangerous goods.
IMDG
Not regulated as dangerous goods.
MARPOL Annex II applies to liquids used in a ship's operation that pose a threat to the marine
environment. These materials may not be transported in bulk.
Transport in bulk according to
Annex II of MARPOL 73/78 and
the IBC Code
15. Regulatory information
US federal regulations All components are on the U.S. EPA TSCA Inventory List.
One or more components are not listed on TSCA.
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.
US. 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 - No
Fire Hazard - No
Pressure Hazard - No
Reactivity Hazard - No
SARA 302 Extremely hazardous substance
Not listed.
SARA 311/312 Hazardous
chemical
No
SARA 313 (TRI reporting)
Chemical name CAS number % by wt.
2-PHENOXYETHANOL 122-99-6 1
Other federal regulations
Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List
Not regulated.
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Material name: HAVRIX JUNIOR
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SDS US
Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)
Not regulated.
Safe Drinking Water Act
(SDWA)
Not regulated.
US state regulations
US. Massachusetts RTK - Substance List
Not regulated.
US. New Jersey Worker and Community Right-to-Know Act
Not regulated.
US. Pennsylvania RTK - Hazardous Substances
Not regulated.
US. Rhode Island RTK
Not regulated.
US. California Proposition 65
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material is not known to contain
any chemicals currently listed as carcinogens or reproductive toxins.
International Inventories
Country(s) or region Inventory name On inventory (yes/no)*
NoAustralia Australian Inventory of Chemical Substances (AICS)
NoCanada Domestic Substances List (DSL)
NoCanada Non-Domestic Substances List (NDSL)
NoChina Inventory of Existing Chemical Substances in China (IECSC)
NoEurope European Inventory of Existing Commercial Chemical
Substances (EINECS)
NoEurope European List of Notified Chemical Substances (ELINCS)
NoJapan Inventory of Existing and New Chemical Substances (ENCS)
NoKorea Existing Chemicals List (ECL)
NoNew Zealand New Zealand Inventory
NoPhilippines Philippine Inventory of Chemicals and Chemical Substances
(PICCS)
NoUnited States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory
*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 04-14-2014
Revision date 04-14-2014
Version #04
Further information HMIS® is a registered trade and service mark of the NPCA.
HMIS® ratings Health: 1
Flammability: 0
Physical hazard: 0
NFPA ratings Health: 1
Flammability: 0
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.
Revision Information Product and Company Identification: Product and Company Identification
Composition / Information on Ingredients: Ingredients
Regulatory Information: United States
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Material name: HAVRIX JUNIOR
130426 Version #: 04 Revision date: 04-14-2014 Issue date: 04-14-2014
SDS US