NV MEPIVACAINE INJECTION

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

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Active ingredient:
MEPIVACAINE HYDROCHLORIDE
Available from:
CEVA ANIMAL HEALTH PTY LTD
INN (International Name):
mepivacaine HCl(20mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
MEPIVACAINE HYDROCHLORIDE CAINE Active 20.0 mg/ml
Units in package:
100mL; 10mL; 12 x 10mL; 12 x 20mL; 20mL
Class:
VM - Veterinary Medicine
Manufactured by:
CEVA ANIMAL HEALTH
Therapeutic group:
HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL
Therapeutic area:
ANAESTHETICS/ANALGESICS
Therapeutic indications:
ANAESTHETIC - LOCAL/GENERAL | GENERAL ANAESTHETIC | IMMOBILISER | LOCAL ANAESTHETIC | PREMEDICATION | SEDATIVE | TRANQUILLISER | TRAVEL SICKNESS
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat: (Horses): 28 days; Host/pest details: HORSE: [ANAESTHETIC - LOCAL/GENERAL]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [ANAESTHETIC - LOCAL/GENERAL]; Non irritant local anaesthetic injection for horses.
Authorization status:
Registered
Authorization number:
47711
Authorization date:
2020-07-01

Company Name:

Product Name:

APVMA Approval No:

CEVA ANIMAL HEALTH PTY LTD

NV MEPIVACAINE INJECTION

47711/101497

Label Name:

NV MEPIVACAINE INJECTION

Signal Headings:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Constituent

Statements:

MEPIVACAINE HYDROCHLORIDE 20 mg/ml

Claims:

Non-irritant local anaesthetic injection for horses.

Net Contents:

100mL

10mL

12 x 10mL

12 x 20mL

20mL

Directions for Use:

Restraints:

Contraindications:

Precautions:

Side Effects:

Dosage and

Administration:

Any unused portion of product should be discarded 6 months after first broaching the vial.

The product should be stored upright after broaching the vial.

Administer by intramuscular or subcutaneous injection.

Nerve Block: 5-10 mL by perineural injection.

RLP

APPROVED

Low Epidural Anaesthesia: 2.5mL per 100kg bodyweight or to effect.

General Directions:

Withholding Periods:

MEAT WITHHOLDING PERIOD (HORSES): 28 DAYS.

Trade Advice:

Safety Directions:

First Aid Instructions:

FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre (Phone

131126).

First Aid Warnings:

Additional User

Safety:

Environmental

Statements:

Disposal:

DISPOSE of empty container by wrapping with paper and putting in garbage.

Storage:

STORE below 25°C (Air Conditioning). Protect from light.

MepivacaineInjection

CreationDate: April 2006

RevisionDate: May2011

Version:2

Nextrevisiondue:May2016

Material SafetyData Sheet

Mepivacaine Injection

Page1 of8

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 Mepivacaine Injection

OtherNames:

Mepivacaine

Synonymsfor the activeconstituent (mepivacaine):Chlorocain, carbocaine

Manufacturer’sProduct Code:

MEP

UN Number:

None allocated

Dangerous Goods Classand SubsidiaryRisk:

None allocated

Hazchem Code:

None allocated

SUSDP Poisons Schedule Number:

S4

Use:

Nonirritant local anaesthetic injection for horses.For animal treatment only.

Section 1 – Identificationof Materialand Supplier

MepivacaineInjection

CreationDate: April 2006

RevisionDate: May2011

Version:2

Nextrevisiondue:May2016

Material SafetyData Sheet

Mepivacaine Injection

Page2 of8

Statement of Hazardous Nature:

Hazardousaccording tocriteria ofNOHSC Australia.

Risk Phrases:None

SafetyPhrases:

S46 Ifswallowed,contacta doctor orPoisonsInformation Centreimmediately and show this

container orlabel.

The substance isacomplexmixture,including the following ingredients.

Ingredients:

Chemical NameCAS Number Proportion

*Mepivacaine Hydrochloride 1722-62-9 2% (20 mg/mL)

Benzyl Alcohol 100-51-6less than 10%

Ingredientsdeterminednot tobehazardous to100

Swallowed:

Ifpoisoning occurs,contact a doctororPoisonsInformation Centre(Phone131126)and show doctor

a copyofthisMSDS.

Eye:

Firstaid is(notgenerally required). Ifin eyes,holdeyelidsopen and flush gentlywithcopious

quantities ofwateruntil substanceis removed (upto15minutes).

Skin:

Removecontaminatedclothing.Washskingentlywithwaterandnon-abrasivesoap.

Inhaled:

Notexpected tobe a significantroute ofexposure duringnormaluse.

First Aid Facilities:

No specific first aidfacilities required.

Advice to Doctor:

Treatment should besymptomaticandsupportive, withattentiontosupportingventilationand

arresting convulsions.Diazepamorthiopentone sodiummay beusedtocontrol convulsions.

Section 2 – Hazards Identification

Section 3 – Composition /Information on Ingredients

Section 4 – First Aid Measures

MepivacaineInjection

CreationDate: April 2006

RevisionDate: May2011

Version:2

Nextrevisiondue:May2016

Material SafetyData Sheet

Mepivacaine Injection

Page3 of8

Fire/Explosion Hazard:

There isnoriskofexplosionfrom this product. The productisnotreadily combustible.

Flashpoint: Flammability Limits:

Not applicable Non-flammable.

Extinguishing Media:

Nospecificrequirements.Useextinguishingmediasuitedtotheenvironmentalmaterialsinvolvedin

thefire.

Special FireFighting Procedures:

Wearself-contained breathing apparatusand full protectiveclothingin accordancewithnormalfire-

fightingprocedures.

Hazchem Code:

None allocated.

EmergencyProcedures:

Noneprescribed.

Methods and Materials for Containment and CleanUp Procedures:

Prevent spill from spreading. Cleanup spillusing suitable adsorbentmaterial. Disposeof waste in

accordancewithlocal,stateandfederallaws.Washareawithwateranddetergent.

Precautions forSafe Handling:

No specific protectiveclothingrequired.When handling this product,wash hands before eating,

drinking, or touching face/eyes.

Storage:

Keepoutercontainerstightlyclosedandoutofreachofchildrenandunauthorisedpersons.

Adheretostorage requirements aslistedon label ( STOREbelow25 C [AirConditioning].Protectfrom

light. ).

Section 5 – Fire Fighting Measures

Section 6 – Accidental Release Measures

Section 7 – Handling and Storage

MepivacaineInjection

CreationDate: April 2006

RevisionDate: May2011

Version:2

Nextrevisiondue:May2016

Material SafetyData Sheet

Mepivacaine Injection

Page4 of8

National ExposureStandards:

NOHSC has notlistedexposurelimits formepivacaine.

Biological LimitValues:

NoBLVshavebeenestablishedfortheingredientsinthisproduct.

BLVsare referencevalues for the evaluation ofpotential healthrisks 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:

Nospecificprotectiveclothingrequiredfornormaluse.

Appearance:

Clear colourless aqueoussolution in 100 mL or 10mL x 12labelled amber glassvials witha rubber

stopperandaluminiumcappackagedinalabelledoutercarton.

Odour:

non-specific

pH:

No data

Vapour pressure: Vapour density:

Notdetermined. Notdetermined.

BoilingPoint: Freezing/Melting Point:

Expectedtobe~100°C Notdetermined.

Solubility:

Solutioniswater-based. 100% miscibleinwater.

SpecificGravity:

~1.00

Other Properties:

No otherinformation.

Section 8 – ExposureControls /Personal Protection

Section 9 – Physicaland ChemicalProperties

MepivacaineInjection

CreationDate: April 2006

RevisionDate: May2011

Version:2

Nextrevisiondue:May2016

Material SafetyData Sheet

Mepivacaine Injection

Page5 of8

ChemicalStability:

Product isnotlikelytoreactordecomposeundernormalstorageconditions.

Conditions toAvoid:

No data.

IncompatibleMaterials:

No data.

Hazardous Decomposition Products:

No data.

Hazardous Reactions:

Nohazardous reactions suchaspolymerizationknown.

Health Effects:

Acute poisoning is unlikelytooccur undernormalconditionsofuse.However,in cases ofaccidental

or deliberate self-injection orifthe productisswallowed,seek medicalattention immediately.

Inhumans, mepivacaine has been usedforalltypesofinfiltrationand regional nerve block

anaesthesiaandalsoforspinalanaesthesia.Thedoseinhumansis upto7mg/kgBW(EMEA

1999) 1 .

(i.v.mouse)and LD

(i.v.rat)rangedfrom35-44mg/kg.

The common symptomsassociatedwithadministrationoflow doses ofmepivacaine include

stimulationofthe corticaland othercerebral functions (eg hyperactivity,hyperreflectivity, tremors).At

highdoses,thereisaprogressiveascendingdepressionoffunctionsresultinginsleepiness,stupor,

ataxia and eventual loss ofconsciousness.Nauseaandvomitingmayoccur aftersystemic

administration. Mepivacaine can also causevasodilationandanincrease in forearm blood flow.

The available pharmacologicaland toxicological studiesare too limited toallowtheestablishment of

anaNOEL and therefore noADI can beestablished.

Acute:

Swallowed:Toxicityfollowingoraladministration isunlikely.Effects associatedwithits

anaestheticactioncanbeexpected,forexamplenumbingofgumsandtonguemay be

anticipated.

EMEA (1999) Mepivacaine SummaryReport,),EuropeanAgencyfor theEvaluationofMedicinalProducts,Committeefor

VeterinaryMedicinalProducts.

Section 10 – Stabilityand Reactivity

Section 11 – Toxicological Information

MepivacaineInjection

CreationDate: April 2006

RevisionDate: May2011

Version:2

Nextrevisiondue:May2016

Material SafetyData Sheet

Mepivacaine Injection

Page6 of8

LD50(oral,mouse):300mg/kg

Eye:Maycausetransientirritationfollowedbynumbingeffect.

Skin:Absorptionviaintactskinis unlikely. Maycause local numbing.

Inhaled:Not consideredtobeasignificantrouteofexposureduringnormaluse.

Chronic:No dataare availableconcerningchronic healtheffects.

Reproductive Effects:Thereisnoevidencethatmepivacainecausesanyreproductiveeffects

(EMEA 1999).

Teratogenic and mutageniceffects:Noevidenceexistsofanyteratogeniceffects.Nodataare

availableconcerningpossiblemutageniceffects.

Carcinogenic Effects:Unknown.No carcinogenicity studieshavebeen performed withmepivacaine.

ToxicitytoOther DomesticSpecies:Administering lowdosesofmepivacaineto domestic species

will give riseto effectsassociatedwith itsanaesthetic action.High dosesareexpected to cause

sleepiness,stupor,ataxia and eventual lossofconsciousness.

Ecotoxicity:The main opportunity for residues to entertheenvironmentwill be via urine and excreta

from treatedanimals.As the quantitiesinvolved will beverysmall, environmental impactsare

expectedtobenegligible.

Persistence /Degradability:Nodata

Mobility:No data

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

Section 12 – Ecological Information

Section 13 – DisposalConsiderations

Section 14 – Transport Information

MepivacaineInjection

CreationDate: April 2006

RevisionDate: May2011

Version:2

Nextrevisiondue:May2016

Material SafetyData Sheet

Mepivacaine Injection

Page7 of8

SUSDP Poisons Schedule Number:4

APVMA ApprovalNumber: 47711

ThisMSDScontainsonly informationrelatedtosafety. Forotherdata,seeproductliterature.

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.

NOHSC NationalOccupationalHealthandSafetyCommission

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 RegulatoryAffairs Manager(02)96527000.

This information hasbeen collated bytechnicalpersonnel employing dataavailablefromtheprime

manufacturerofthematerial. Tothe bestofourknowledgeit istrueandaccurate. It isnotintended

tobe all inclusive andthemanner andconditionsofuse and handling mayinvolve otheroradditional

considerations.

Section 15 – RegulatoryInformation

Section 16 – Other Information

MepivacaineInjection

CreationDate: April 2006

RevisionDate: May2011

Version:2

Nextrevisiondue:May2016

Material SafetyData Sheet

Mepivacaine Injection

Page8 of8

END OF MSDS

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