NV SALSPRIN INJECTION

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
SODIUM SALICYLATE
Available from:
CEVA ANIMAL HEALTH PTY LTD
INN (International Name):
sodium salicylate(250mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
SODIUM SALICYLATE PHENOL Active 250.0 mg/ml
Units in package:
100mL
Class:
VM - Veterinary Medicine
Manufactured by:
CEVA ANIMAL HEALTH
Therapeutic group:
DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
Therapeutic area:
MUSCULOSKELETAL SYSTEM
Therapeutic indications:
ANTI-INFLAMMATORY AGENT | ANTIPYRETIC | BONE SORENESS | BRUISING | BURSITIS | INFLAMMATORY RHEUMATIC ARTHRIT | JOINT DISEASE | LIGAMENT SPRAINS | MUSCLE SORENESS | OSTEOARTHRITIS | PLATELET ACTIVITY | RHEUMATISM | SPRAINS | STRAINS | TENDON SPRAINS | TRAUMATIC SWELLING
Product summary:
Poison schedule: 4; Withholding period: WHP: MEAT(Horses): 28 days.; Host/pest details: DOG: [ANTI-INFLAMMATORY AGENT]; HORSE: [ANTI-INFLAMMATORY AGENT]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANTI-INFLAMMATORY AGENT]; HORSE: [ANTI-INFLAMMATORY AGENT]; Anti-inflammatory anti-pyretic, anti-thrombotic therapy for horses and dogs.
Authorization status:
Registered
Authorization number:
51161
Authorization date:
2019-07-01

Infopest verifies that this label is consistent with the

NRA Approved Text Label

8 June, 2000

Draft Label: Salsprin

Carton and Container identical but carton has

centre panel repeated back and front

READ

THE

ENCLOSED

LEAFLET

BEFORE

USING THIS PRODUCT.

DIRECTIONS FOR USE:

Administer by slow intravenous injection.

Dose Rates:

Anti-inflammatory

Anti-thrombotic

10 mg/kg every 12

hours

3 mg/kg every 6

days

Horse

35 - 45 mg/kg

every 8 - 12 hours

5 mg/kg every 2nd

day or 20 mg/kg

every 5th day

If used in performance animals, the regulations

of the relevant authorities regarding medication

should be observed.

MEAT

WITHHOLDING

PERIOD

(HORSES):

28

DAYS.

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

NV

SALSPRIN

Injection

ACTIVE CONSTITUENT:

SODIUM SALICYLATE

250 mg/mL

Anti-inflammatory anti-pyretic, anti-thrombotic

therapy for horses and dogs.

100 mL

Dispose

of empty container by wrapping with paper

and putting in garbage.

Store

below 25

C (Air Conditioning).

Protect from light

.

NRA; 51161/1299

Batch No.:

Expiry Date:

Nature Vet Pty Limited

299 Castlereagh Road

Agnes Banks NSW 2753

Tel: (61) 2 4578 1022

Fax: (61) 2 4578 2913

www.naturevet.com.au

SALSPRIN Injection

CreationDate:12Feb2007

RevisionDate: Sep 2011

Version:2

Nextrevisiondue:Sep2016

Material SafetyData Sheet

SALSPRINInjection

COMPANY DETAILS

Company: Address:

CevaAnimal HealthPtyLtd 11MooresRoad

ABN54002692 426 Glenorie NSW 2157 Australia

Telephone Number: FacsimileNumber:

+61 (02)9652 7000 +61(02)96527001

EmergencyTelephone Number:

+61 (02)9652 7000 (Business Hours)

Poisons InformationCentre:131126

SUBSTANCE IDENTIFICATION

Product Name:

NV SalsprinInjection

OtherNames:

Salsprin

Chemicalnameof activeconstituent,SodiumSalicylate:Sodium2-hydroxybenzoate

Manufacturer’sProduct Code:

UN Number:

None allocated

Dangerous Goods Classand SubsidiaryRisk:

None allocated

Hazchem Code:

None allocated

SUSDP Poisons Schedule Number:

S4

Use:

Injectable antiinflammatory,antipyreticand antithrombotic foruseinhorses anddogs.Foranimal

Section 1 – Identificationof Materialand Supplier

SALSPRIN Injection

CreationDate:12Feb2007

RevisionDate: Sep 2011

Version:2

Nextrevisiondue:Sep2016

Material SafetyData Sheet

SALSPRINInjection

Statement of Hazardous Nature:

Hazardousaccording tocriteria ofNOHSC Australia.

Risk Phrases:

None.

SafetyPhrases:

None.

The substance isacomplexmixture,including the following ingredients.

Ingredients:

ChemicalName CASNumber Proportion

Sodium Salicylate 54-21-7 25%(25 mg/mL)

Sodium Metabisulfite 7681-57-4 less than10%

BenzylAlcohol 100-51-6 less than10%

Ingredientsdeterminednot tobe

hazardous to100%

Swallowed:

Ifswallowed,immediatelycontact a doctororPoisonsInformation Centre(Phone131126)and show

doctora copy ofthisMSDS.

Eye:

Maycausetransienteyeirritation. Ifin eyes, hold eyelidsopen and flushgentlywithcopious

quantitiesofwateruntil substanceisremoved(upto15minutes).

Skin:

Removecontaminated clothing.Washskin gentlywithwaterandnon-abrasivesoap.No further

measuresare normally required.

Inhaled:

Notexpected tobe a significantroute ofexposure duringnormaluse.

First Aid Facilities:

No specific first aidfacilities required.

Section 2 – Hazards Identification

Section 3 – Composition /Information on Ingredients

Section 4 – First Aid Measures

SALSPRIN Injection

CreationDate:12Feb2007

RevisionDate: Sep 2011

Version:2

Nextrevisiondue:Sep2016

Material SafetyData Sheet

SALSPRINInjection

Advice to Doctor: Treat symptomatically.Note the nature of the product(salicylic acidderivative

thathas analgesic,anti-inflammatory,andantipyretic actions similartothose ofaspirin).

Fire/Explosion Hazard:

There isnoriskofexplosionfrom this product. The product isnotreadilycombustible.

Flashpoint: Flammability Limits:

Not applicable Non-flammable.

Extinguishing Media:

No specific requirements. Use extinguishing media suited totheenvironmentalmaterialsinvolved in

thefire.

Special FireFighting Procedures:

Wearself-contained breathing apparatusand full protectiveclothingin accordancewithnormal fire-

fightingprocedures.

Hazchem Code:

None allocated.

EmergencyProcedures:

Noneprescribed.

Methods and Materials for Containment and CleanUp Procedures:

Absorb spillswith absorbent paper,cloth orother absorbent material(e.g.sand, soil) and dispose of

ingarbage.Spills mayalsobewashedawaywithwater.

Precautions forSafe Handling:

Nospecial precautions.

Storage:

Adheretostorage requirements aslistedon label (Storebelow25 C.Protectfromlight).

Section 5 – Fire Fighting Measures

Section 6 – Accidental Release Measures

Section 7 – Handling and Storage

SALSPRIN Injection

CreationDate:12Feb2007

RevisionDate: Sep 2011

Version:2

Nextrevisiondue:Sep2016

Material SafetyData Sheet

SALSPRINInjection

National ExposureStandards:

NOHSChasnot listed exposurelimitsforanyingredients inthisproduct.Swallowing andinhalation

arenotlikelyundernormalconditionsofuseorstorage.

Biological LimitValues:

No BiologicalLimitValues have been establishedforanyingredientsin the product.

BLVsare referencevalues for the evaluation ofpotentialhealthrisks in the practiceofindustrial

hygiene. Biologicalmonitoring involvesthemeasurement ofsubstances in biological media(eg blood,

urine,etc.) and the measurement ofbiologicaleffectsinduced bythesubstance.

Engineering Controls:

No engineering controlsallocated.

Personal ProtectiveEquipment:

No specific protectiveclothingrequired.

PhysicalDescription/Properties:

Appearance:

Clearcolourlesstopale straw coloured solution forinjection contained in a100 mL labelled amber

glassvial witha rubberstopper and aluminium cap,packagedinalabelledouter carton.

BoilingPoint

Expectedtobe~100°C.

MeltingPoint:

Expectedtobe~0°C.

Vapour Pressure:

No data.

SpecificGravity:

Notapplicable

Flashpoint:

Notdetermined

FlammabilityLimits:

Notdetermined

SolubilityinWater:

Miscibleinwater

Section 8 – ExposureControls /Personal Protection

Section 9 – Physicaland ChemicalProperties

SALSPRIN Injection

CreationDate:12Feb2007

RevisionDate: Sep 2011

Version:2

Nextrevisiondue:Sep2016

Material SafetyData Sheet

SALSPRINInjection

Other Properties:

No otherinformation

ChemicalStability:

Product isnotlikelytoreactordecomposeundernormalstorageconditions.

Conditions toAvoid:

No data.

IncompatibleMaterials:

No knownincompatibilities.

Hazardous Decomposition Products:

Uponthermal decomposition,may emittoxicgasesincluding carbonmonoxideand carbondioxide.

Hazardous Reactions:

Nohazardous reactions suchaspolymerizationknown.

Health Effects:

Acute:

The following LD50s applytothe activeingredient,SodiumSalicylate.

oralmouse: 540 mg/kg

oral,rat 1200mg/kg

oral,rabbit1700 mg/kg

The mostlikelyroute ofexposure is byaccidentalselfinjection.

Swallowed:

Morethan 10,000 tonsofaspirin (acloselyrelatedsalicylate) areconsumedintheUnitedStates each

year. Salicylate intoxication persistsas animportantcause ofmorbidityandmortality 1 .Signs ofacute

poisoningmay include nausea,vomiting,gastricirritationand thirst,possibly leadingtoweakness,

hypotension(low blood pressure),rapid heartbeat,rapidbreathing,delirium and respiratoryarrest.

Eye:

Maycause transientirritation.

Skin:

Maycause transientirritation.

Inhaled:

Not asignificantrouteofexposureduringnormal useoftheproduct.

Section 10 – Stabilityand Reactivity

Section 11 – Toxicological Information

SALSPRIN Injection

CreationDate:12Feb2007

RevisionDate: Sep 2011

Version:2

Nextrevisiondue:Sep2016

Material SafetyData Sheet

SALSPRINInjection

Chronic:

Medicalexperience indicatessodium salicylate isoflowhazard inusual doses.It is normally rapidly

excretedfromthebody;howeverinpersons withimpairedrenal functionlevelsinthebodymay

rapidlybuildup.Prolongeduse ofnon-steroidal analgesics damages the liningofthegastrointestinal

tract,causingulcersandbleeding.Theremaybediarrheaorconstipation,perforations causing

seriousinfection,andbloodinthe vomit orstools.Kidneydamage can resultinbloodorpus in the

urine,changesinurine chemistry,changein the frequencyofurination,insufficiencyofkidney

function,destructionofthekidneylining and kidneyinflammation.Occasionally,the liver maybe

affected,causinginflammation(hepatitis)and jaundice.Theremaybechanges inbloodcell

distribution,anddisturbanceinplateletfunction. Sensitivity tolightmayoccur.Anaphylatic-like

syndromeischaracterizedbyrashwithredness,spotsand blisters, itching,and fainting. Theeyes,

earsandurinarytractcan all be affected.Asthmaand anemiamaybeexacerbated.Thesedrugs can

causecirculatorydefects inthefetusandnewborn.Once thekidneyhasbeendamaged,thereisan

increasedlikelihood thatcancerscould develop there.

Chronicexposuretosalicylates produce problemswithmetabolism,central system disturbances,or

kidneydamage.Thosewithpre-existingdamagetotheeye,skinorkidneyareespeciallyatrisk.

Hypersensitivereactionscan occur,especiallyinpeoplewithasthma.Thesesymptomsincludeitchy

whealsandotherskineruptions,aninflamednose,shortnessofbreathandseriousnarrowingofthe

airways(which can evencause death).

Reproductive Effects: Fertility: Post-implantationmortality, oral-rat

TDLo=250mg/kg.PaternalEffects:Testes/spermduct/epididymis,intraperitoneal-rat

TDLo=600mg/kg.

Teratogenic and mutageniceffects:Exposuretothe material forprolonged periodsmaycause

physicaldefects in the developing embryo(teratogenesis).

Mutagenicity ofaspiron inSalmonella:negative

Carcinogenic EffectsNota knowncarcinogen.

ToxicitytoOther DomesticSpecies:Nodata.

Ecotoxicity:Themajorpathwaythatresiduescouldenter the environmentisvia the urine and faeces

oftreatedanimals.Quantities involvedarelikelytobeverysmall and no adverseeffectstothe

environmentareexpected.

Persistence /Degradability:Nodata

Mobility:No data

Section 12 – Ecological Information

SALSPRIN Injection

CreationDate:12Feb2007

RevisionDate: Sep 2011

Version:2

Nextrevisiondue:Sep2016

Material SafetyData Sheet

SALSPRINInjection

Disposal of emptyorused containers:Dispose ofin accordance withLocal,State,Federal and

EPA (Environmental ProtectionAuthority)wasteregulations.

UN Number:Noneallocated

Dangerous Goods Classand SubsidiaryRisk:None allocated

Hazchem Code:Noneallocated

This productisnot classifiedasa Dangerous Good.Nospecial transportconditions.

SUSDP Poisons Schedule Number:4

APVMA ApprovalNumber:51161

This MSDS contains onlyinformation related tosafety.For other data, seeproduct literature.

Readall labels andpackageinsertscarefullybefore usingthis product.

Glossaryand Acronyms:

ADI AcceptableDaily Intake,aslistedintheAustralianADIList,August2003.

CASNumber Uniquenumber assigned bythe ChemicalAbstractsService,Columbus,

Ohio,USA.

EMEA European Agencyfor the Evaluation ofMedicinalProducts –Committeefor

VeterinaryMedicinal Products; 7 WestferryCircus,CanaryWharf,London

E14 4HB,UK;ph(+44-171)418 8400; fx(+44-171)418 8416

HazchemCode Emergencyaction codeofnumbersand letters givinginformation to

emergency services.

50 Lethaldose for 50 % ofa group ofspecifiedtestanimals.

MSDS MaterialSafetyDataSheet(alsocalled SafetyDataSheetinsome

countries).

NOEL NoObservableEffectLevel,aslistedinthe Australian ADIList,August2003.

Section 13 – DisposalConsiderations

Section 14 – Transport Information

Section 15 – RegulatoryInformation

Section 16 – Other Information

SALSPRIN Injection

CreationDate:12Feb2007

RevisionDate: Sep 2011

Version:2

Nextrevisiondue:Sep2016

Material SafetyData Sheet

SALSPRINInjection

RiskPhrase Standardphrasedescribingthehazardofa substance as provided in the

NOHSC“Approved Criteria for Classifying Hazardous Substances

[NOHSC:1008]”

SafetyPhrase Standard phrase describingthesafehandling,storage or use ofpersonal

protectiveequipmentfor a material as providedintheNOHSC“Approved

CriteriaforClassifyingHazardousSubstances[NOHSC:1008]”

SUSDP StandardfortheUniformSchedulingofDrugs&Poisons

TWA Time Weighted Average

UNNumber UnitedNationsNumber

CONTACT POINT

CevaAnimal HealthPtyLtd RegulatoryAffairsManager (02) 9652 7000.

This information hasbeen collated bytechnicalpersonnel employing dataavailablefromtheprime

manufacturerofthematerial.Tothebest ofourknowledgeitistrueandaccurate. Itisnotintended

tobe all inclusive andthemanner andconditionsofuse and handling mayinvolve otheroradditional

considerations.

END OF MSDS

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