fr\ MATERIAL SAFETY DATA SIMET
SECTION 1- PRODUCT & COMPANY IDENTIF'ICATION
(800)ss1-7176
Telephone
1501East Woodfield Road Emergency
Suite300East
60173
Schaumburg,IL
(847\ 969-2700
InjectiorLUSP
Phosphate
S.odium
Dexamethasone
Product Identifier:
Dexamethasone
Phosphate
ChemicalName:
Anti-Inflammatory
Category:
SECTION 2. COMPOSITION
CASNumber Amount
Ingredient
2392-39-4 4mglmL or 10 mg/
Dexamethasone
Phosphate
mL
l-6
100-5 10 mg/ml in
BenzylAlcohol
preservedproduct
6132-04-3 Seepackage insert
SodiumCitrateDihydrate
Seepackage
7757-83-7 insert
SodiumSulfite
7732-18-5
Water for Injection QS
SECTION 3 - HAZARDS IDENTIFICATION
Inhalation,eye/skincontact, ingestion
or
Route of Entry:
Chemical Listing as
Carcinogen
No
NTP:
No
IARC:
No
OSIIA:
NA
Note:
SECTION 4 - EMERGENCY & FIRST AID MEASURES
Immediatelyflush eyeswith water for at least 15 minutes. Seekmedicalattention.
Eyes:
clothing immediately. Flush areawith water for at least 15
Removecontaminated
Skin:
areawith soapand water. Seekmedical attentionif pain,
minutes. Wash exposed
redness, swellingpersists.
or
American PharmaceuticalPartners,Inc.
Sodium Phosphate
Dexamethasone Injection, USP
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SECTION 4 - EMERGENCY & FIRST AID MEASURES...CONtiNUEd
and
subjectto freshair immediately. Give artificial respiration
Move exposed
Inhalation:
(CPR) if required. Seekmedicalattention.
resuscitation
cardiopuimonary
Flush mouth out with waterimmediately. Seekmedicalattention'
Ingestion:
For AdverseEvent Information,pleasecall (800) 551-7176 (847) 969-2700'
or
Contact Info:
SECTION 5 - FIRE FIGHTING MEASURES
Fire and Explosion Data
NE
ClosedCup Flash
Point:
NE
Open Cup Flash
Point:
NE
Fire Point:
NE
Autoignition:
NE
Lower Explosion
Limit:
NE
Upper Explosion
Limit:
toxic fumesmay be emitted.
When heatedto decomposition,
General Harardz
Water spray,dry chemical,carbondioxide, or foam as appropriate surroundings'
to
Fire Fighting
Instructions:
breathingapparatus protectiveclothing.
and
Wear self-containing
Fire Fighting
Equipment:
materialemits toxic fumesof fluorine, phosphate,
When heated decomposition,
to
HazardousCombustion
and sodiumbicarbonate.
Products:
SECTION 6 - ACCIDENTAL RELEASE MEASURES
(SeeSection8 - Exposure
protective
personal equipment
Wearrecommended
Clean-Up:
towels or broomsto clean-upspill'
Protection). Use absorbent
Controls/Personal
Wipe surfaceareaclean with soapand water.
SECTION 7 - HANDLING AND STORAGE
products,avoid all contactand inhalationof dust,
When handlingpharmaceutical
General Handling:
with the product.
fumes,mist, and/orvaporsassociated
American PharmaceuticalPartners,Inc.
Sodium PhosphateInjection, USP
Dexamethasone
P a g e2 o f 6
Version: 2.0.0
Revision date: 08/10105,
SECTION 7 - HANDLING AND STORAGE...continued
productsat controlledroom
phosphate
Storethe 4 m{mL dexamethasone
StorageConditions:
15oto 30"C (59'to 86'F). [SeeUSP ControlledRoom Temperature]'
temperature
productsat25"C (77"F),excursions
phosphate
Storethe 10 mg/ml dexamethasone
Room Temperature].
15i to 30"C (59" to 86"F) [SeeUSP Controlled
permittedto
Protectfrom freezing. Sensitiveto heat. Do not autoclave.Protectfrom light.
SECTION 8 . EXPOSURE CONTROLS/PERSONAL PROTECTION
Generalroom ventilationis satisfactory.Use local exhaustventilationif necessary'
EngineeringControls:
Personal Protective
Equipment
Safetyglasses gogglesrecommended.
or
Eye Protection:
latex glovesrecommended'
Disposable
IIand Protection:
protectionis usuallynot required.
ventilation,respiratory
With satisfactory
Respiratory
Protection:
garments direct skin contactis anticipated.
if
Disposable
Skin Protection:
Exposure Limits:
OEL
TYpe
Issuer
Comoound
NE
PEL
OSHA
Phosphate
Dexamethasone
NE
TLV
ACGIH
NE
STEL
NE
PEL
OSHA
Benzyl Alcohol
NE
TLV
ACGIH
NE
STEL
NE
PEL
OSHA
SodiumCitrateDihydrate
NE
TLV
ACGIH
NE
STEL
NE
PEL
OSHA
SodiumSulfite
NE
TLV
ACGIH
NE
STEL
NE
PEL
OSHA
Water for Injection
NE
TLV
ACGIH
NE
STEL
SECTION 9. PIIYSICAL AND CHEMICAL PROPERTIES
solution
Clear,colorless paleyellow, odorless
to
PhysicalForm/
Appearance:
American PharmaceuticalPartners,Inc.
Injection, USP
Sodium Phosphate
Dexamethasone
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SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES...continued
NE
Boiling Point/Boiling
Range:
NE
Melting Point/Melting
Range:
NE
Freezing Point:
NE
Vapor Pressure:
NE
Relative Vapor Density:
NE
PercentVolatiles:
pH: 7.0-8.5
516.41
Molecular Weight:
in
Soluble water
Solvent Solubility:
NA
Note:
SECTION 10. STABILITY AND REACTIVITY
Stableundermost conditions.
Stability:
Exposureto excessive light and heatmay causedecomposition. not autoclave.
Conditionsto Avoid: Do
Protectfrom freezing.
Will not occur
Hazardous
Polymerization:
SECTION 11 - TOXICOLOGY INFORMATION
This productis intendedfor therapeutic only when prescribed a physician.
Signs Symptoms
& of use by
Exposure
& Potentialadverse reactionsfrom prescribeddosesand overdoses described
are in
Overexposure: the packageinsert. Glucocorticoidsmay causeprofound and varied metabolic
effectsand modify the body'simmuneresponses.
Side effectsfrom therapeutic dosesinclude:sodiumand fluid retention,congestive
heartfailure (in susceptible
patients),
hypokalemi4hypertension, muscle
weakness, peptic ulcer, perforationof the large and small
osteoporosis,fractures,
bowel, pancreatitis,impairedwoundhealing,skin reactions, convulsions,
headache, vertigo, cushingoidstate,cataracts,glaucoma,weight gain, increased
appetite,nausea, malaiseand hiccups.
Occupational
exposure not beenfully
has
Dexamethasone
SodiumPhosphate
Injection,
USP American PharmaceuticalPartners,Inc.
Revision
date:08/10/05.
Version:
2.0.0 Page 4 of 6
SECTION 11 - TOXICOLOGY INFORMATION...continued
of
conditions.Hypersensitivity any component
to
skin and respiratory
Pre-existing
Medical Conditions
reactions
product,includingsulfites. Sodiumbisulfite may causeallergic-type
the
Aggravated by
and life-threatening lesssevereasthmatic
or
symptoms
includinganaphylactic
Accidental Exposure:
may exacerbate
use of corticosteroids
people.Therapeutic
episodes susceptible
in
and shouldnot be usedin the presence such
of
fungal infections
systematic
infections.
Acute Toxicity:
Dosage
Route Species
Tvpe
Compound
6.5 gm/kg
Female
Oral
LD:o
Phosphate
Dexamethasone
Mouse
794 mgll
Female
IV
LDso
Mouse
ACUTE EFFECTS:
Other:
In the eventof an overdose, specificantidoteis available. Treatmentis
no
supportiveand symptomatic.
DELAYED EFFECTS:
glaucom4 hypertension,
Prolongedexposue may result in subcasular cataracts,
salt and water retention,and hypokalemia.
TERATOGENICITY:
sodium phosphate pregnancy
in
PregnancyCategoryC. Use of dexamethasone
benefitsbe weighedagainstthe potentialrisks to the
requiresthat the anticipated
mother and fetus.
SECTION 12 - TRANSPORTATION INFORMATION
NA
UN/NA Numben
NA
U.S. DOT Hazard
Class:
NA
Proper Shipping Name:
NA
Shipping Label:
SECTION 13. DISPOSAL INFORMATION
transportation, disposalmust be in accordance
with
and
Treatment,storage,
DisposalProcedure:
applicablefederal,state,and local regulations.
American PharmaceuticalPartners,Inc
Sodium PhosphateInjection, USP
Dexamethasone
P a g e5 o f 6
Revision date:08/ 10/05, Version: 2. 0.0
SECTION 14 - OTHER
ACGIH - American Conference GovemmentalIndustrial Hygienists
of
Kev to Abbreviations:
HEPA - High EfficiencyParticulate Air
IARC - InternationalAgency for Research Cancer
on
NA - Not Applicable
NE - Not Established
NG - Not Given
NIOSH - National Institutefor OccupationalSafetyand Health
NTP - National Toxicology Program
OEL - Occupational Exposure Limit
OSHA - Occupational Safetyand Health Administration
PEL - PermissibleExposure Limit
PPM - PartsPer Million
QS - Quantity Sufficient
RCRA - Resource Conservation RecoveryAct
and
STEL - ShortTerm Exposure Limit
TLV - ThresholdLimit Value
USP - United States Pharmacopeia
hereinpertainsto this material. It is the responsibility
The informationcontained
Disclaimen
party to determine themselves propermeansof handling
of eachindividual for the
and using thesematerialsbasedon their purposeand intendeduse. American
Inc. assumes liability resultingfrom the use of or
no
Pharmaceutical Partners,
relianceupon the informationcontained this materialsafetydatasheet. This
in
material safetydatasheetdoesnot constitutethe guarantyor specifications the of
product.
Dexamethasone
Sodium PhosphateInjection, USP American PharmaceuticalPartners,Inc.
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