IRAMINE TABLETS

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

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Active ingredient:
CHLORPHENIRAMINE MALEATE
Available from:
MAVLAB PTY LTD.
INN (International Name):
chlorpheniramine as maleate(2.8mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
CHLORPHENIRAMINE MALEATE ANTIHISTAMINE Active 4.0 mg/Tb
Units in package:
100 Tabs; 1000Tabs
Class:
VM - Veterinary Medicine
Therapeutic group:
CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
Therapeutic area:
DERMATOLOGICAL PREPS.
Therapeutic indications:
PRURITIS | ALLERGIC SKIN DISORDER
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [PRURITIS]; DOG: [PRURITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [PRURITIS]; DOG: [PRURITIS]; For the relief of pruritus associated with allergic skin disorders in dogs and cats.Do not use in animals with glaucoma, prostate disease, stomach or intestinal obstruction, urinary obstruction, certain heart or lung diseases, high blood pressure or hyperthyroidism. Do not use in pregnant or lactating animals
Authorization status:
Registered
Authorization number:
53915
Authorization date:
2019-07-01

APPROVED

LABEL

NAME:

APPLICANT:

FILE NAME:

DIMENSION:

SCALE:

NATURES ANSWER PERNAEASE POWDER

MAVLAB PTY LTD

59494_35924_250g_ LABEL_ MPL_V2

ACTUAL LABEL SIZE = (270mm WIDE X 50mm DEEP)

100% LABEL SIZE

NAME:

APPLICANT:

FILE NAME:

DIMENSION:

SCALE:

DATE:

IRAMINE TABLETS (1000 TABLETS)

MAVLAB PTY LTD

53915_39282_1000T_PRIMARY_MPL_V1

ACTUAL LABEL SIZE = (137mm WIDE X 52mm DEEP)

100% LABEL SIZE

19/09/2006

APPROVED

LABEL

MAVLAB PTY LTD Date of Issue: October 2008

MATERIAL SAFETY DATA SHEET

IRAMINE4MG Page1of4

MSDS version: 3

Date of Revision: October2008

Update of section: All sections

SECTION 1 IDENTIFICATION OF THE MATERIAL AND SUPPLIER

Product (material) name: Iramine Tablets

Othernames: 4 mgChlorpheniramine Tablets;C3100

Recommendeduse: Forthereliefofpruritusassociatedwithallergic skindisorders in dogs and cats

SupplierDetails: MavlabPtyLtdACN 068507148

31 – 33 Rowland Street

SLACKS CREEK QLD 4127

Contact Person: Dr Paul Ross

Emergency Telephone: (07)3808 1399

Facsimile: (07) 3808 4328

SECTION 2 HAZARDS IDENTIFICATION

Thisproductnotdangerousgoodsunder theAustralian Code for the TransportofDangerous GoodsbyRoad and

Rail (ADG Code) but is classified as hazardous accordingto the classification criteria of NOHSC:1008(2004),

ApprovedCriteria For ClassifyingHazardous Substancesand theNational Codeof Practice for the Preparationof

Material Safety Data Sheets2 nd Edition[NOHSC:2011(2003)]

Althoughthis material couldbeclassifiedas dangerous goods onthebasis ofits toxicity, the packsizes inwhichit is

supplied arebelow the minimumsize for sucha classification under theADG Code.

Health Effects

Risk Phrase: R25 -Toxic ifswallowed.

Safety Phrases: S36/37/39-45 -Wearsuitableprotective clothing,gloves, and eye/face protection.Incase

of accident or ifyoufeel unwell, seek medical adviceimmediately (show the labelwhere

possible).

This materialis presentedintablet formandit is therefore not expectedtopose inhalational or dermal health

hazards. However, if tablet integrityis compromised and dust is generated,both dermal andinhalational hazard

couldresult.Inthis case all thefollowingcouldapply:

Ingestion: Toxic if swallowed.

Eye: Dust may irritate the eyes,possible allergicreaction.

Skin: Dust may irritate the skin, may beharmful if absorbedthroughthe skin. Possible allergicreaction

Inhaled: Dustmaybe irritating tomucousmembranes andupperrespiratorytract.Maybeharmfulif

inhaled. Possible allergic reaction

SECTION 3 COMPOSITION/INFORMATION ON INGREDIENTS

Ingredients CasNo. Proportion

Chlorpheniramine Maleate 123-92-8 2.23%

Proprietary,non-hazardous tableting ingredients Balance to 100%

SECTION 4 FIRST AID MEASURES

The followingFirstAid directions have been setbythe Office of Chemical Safety(OCS)of the Commonwealth

DepartmentofHealthandAging:

Ifpoisoningoccurs, contacta doctororPoisonsInformation Centre. Telephone131126. (FAISDHandbook,

Handbook ofFirst AidInstructions, Safety Directions, WarningStatements, andGeneral Safety Precautionsfor,

Agricultural andVeterinary Chemicals)

MAVLAB PTY LTD Date of Issue: October 2008

MATERIAL SAFETY DATA SHEET

IRAMINE4MG Page2of4

MSDS version: 3

Date of Revision: October2008

Update of section: All sections

However, the followingadditional informationisprovidedtoassist inemergency situations, while implementingthe

recommended FirstAid directions:

Swallowed: Washoutmouth withwater providedpersonisconscious.

Eye: Flushwithcopiousamountsofwaterfor atleast15minutes. Assure adequateflushingby

separating the eyelids with fingers.

Skin: Flushwithcopiousamountsofwaterfor atleast15minutes. Remove contaminated clothingand

shoes.

Inhaled: Remove tofresh air. Ifnotbreathinggive artificial respiration.If breathingis difficult,give

oxygen.

Advice to Doctor: Antihistamine, personsdeveloping hypersensitivity (anaphylactic) reactions must receive

immediate medical attention.

SECTION 5 FIRE FIGHTING MEASURES

Suitable extinguishingmedia: Dry chemicalpowder, waterspray, fogorfoam. Do notuse water jet.

Hazardsfromcombustion products: Emits toxic fumes under fireconditions.These products are carbon

oxides(CO,CO

), nitrogen oxides (NO,NO

...).

Special protective precautions

andequipment forfirefighters: Wearself-containedbreathingapparatusandprotective clothingto

prevent contact with skin and eyes.

Hazchem Code: None allocated

SECTION 6 ACCIDENTAL RELEASE MEASURES

Emergency procedures: Contain spilled tablets andavoidas muchas possiblebreakingupthe

tablets and generating dusty conditions. Wear mask, goggles, protective

gloves and appropriate respiratory protection where tablet dust has been

generated

Methods andmaterials for

containment and clean up: Vacuumor sweepup tabletsand othermaterialand placeinto suitable

containers for disposal. Avoidraisingdust. Ventilatearea andwashspill

site after material collection is complete.

SECTION 7 HANDLING AND STORAGE

Precautionsfor safehandling: Handle tabletswithcare sothat tablet integrity ismaintainedand dust

generation isavoided. Do notbreathe dust. Do not get in eyes, on skin,

on clothing. Avoid prolonged or repeated exposure.

Conditionsforsafe storage,

includingany incompatibilities:

The followingstorage directionshave beenapproved bytheAustralian Pesticides& VeterinaryMedicinesAuthority

(APVMA) aspart oftheregistrationprocessfor thisproduct:

Storebelow30 °C (RoomTemperature). Protect fromlight. Replace lid tightly after use.

SECTION 8 EXPOSURE CONTROLS/PERSONAL PROTECTION

Nationalexposurestandards: None allocated

Biologicallimitvalues: None allocated

Engineeringcontrols: Wheredustisgenerateduseadequategeneralorlocalexhaust

ventilation to keep dust levels as low as possible.

Personalprotective equipment: Weargloveswhenhandling

MAVLAB PTY LTD Date of Issue: October 2008

MATERIAL SAFETY DATA SHEET

IRAMINE4MG Page3of4

MSDS version: 3

Date of Revision: October2008

Update of section: All sections

SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES

Appearance: White 7mm FBE Bisect Tablet

Average tabletweight 171mg /tablet

SECTION 10 STABILITY AND REACTIVITY

Chemical stability: Stable

Conditionstoavoid Avoidconditionswhere tablets maybe damagedanddustgenerated.

Avoid high temperatures. Light sensitive.

Incompatible materials Strong oxidizing agents

Hazardous decompositionproducts: Carbon monoxide, carbondioxide, nitrogenoxides,hydrogen chloride

gas.

Hazardous reactions: Hazardouspolymerisation will notoccur

SECTION 11 TOXICOLOGICAL INFORMATION

Healtheffectsfromthe likely routesofexposure

Acute Toxicity:

:

Oral (Rat): 188 mg/kg

Oral (Mouse): 133 mg/kg

Oral(Guineapig): 240 mg/kg

Intraperitoneal(Rat): 84mg/kg

Intraperitoneal(Mouse): 82mg/kg

Intravenous(Mouse): 20mg/kg

Potential Acute HealthEffects: Veryhazardous in case of ingestion. Hazardousincase ofskin contact (irritant),

of eye contact(irritant),of inhalation. Slightly hazardous incaseof skincontact(permeator).

Potential Chronic Health Effects:Noneknown

Repeatedorprolonged exposureisnotknowntoaggravate medicalcondition.

SECTION 12 ECOLOGICAL INFORMATION

Information isnotavailableregarding the ecological effects ofthisproduct.

SECTION 13 DISPOSAL CONSIDERATIONS

Disposalmethodsandcontainers:

The followingdisposaldirectionshavebeenapproved bytheAPVMAforemptycontainers:

Disposeofemptycontainersbywrappinginpaperandplacing ingarbage.

Dispose of unused productinaccordance withlocal municipal authority instructions.

Special precautionsfor landfill orincineration:

Donotburnemptycontainersorunusedproduct.Obtainadvicefromlocalmunicipalauthoritybeforedisposingof

product inlocal authority landfill.

SECTION 14 TRANSPORT INFORMATION

This material isshippedinimmediate containers thathavecapacities below the minimumrequired forit tobe

regulatedbytransportofdangerous goodslegislation.

MAVLAB PTY LTD Date of Issue: October 2008

MATERIAL SAFETY DATA SHEET

IRAMINE4MG Page4of4

MSDS version: 3

Date of Revision: October2008

Update of section: All sections

SECTION 15 REGULATORY INFORMATION

This product has beenregisteredbythe AustralianPesticides andVeterinaryMedicines Authority(APVMA). In

grantingregistrationto anyproduct, theAPVMAhas exercisedits legislative responsibility toensure that the product

issuitablyformulated andproperlylabelledand,whenusedaccordingtoinstructionsis:

safe to thehost, theuser, consumers and theenvironment;

efficacious(that is, theproduct does thejobit claims it shall do); and

notunduly prejudicial to trade.

The APVMA uses the services of a number of AustralianandState government agencies as advisersto help with

someof theseevaluationsofapplicationsfor registrationof agriculturalandveterinarychemicalproducts.These

include:

the Officeof Chemical Safety (OCS)of theCommonwealthDepartmentofHealthandAgeingwhich:

evaluates andreportsontoxicologyandmetabolismstudies;proposes firstaid and safetydirections;

determines poison scheduleclassifications; and establishes acceptable daily intakes (ADIs)and acute

referencedoses (ARfD); and

evaluatesthe occupational healthandsafetyaspectsof an application andrecommends safety directions and

occupationalcontrolsonuse andadvises ona Material Safety Data Sheet(MSDS);

the CommonwealthDepartmentof the Environmentand Heritage(DEH)which evaluates environmentaldata

and recommendsappropriateuse controls andinstructionsfor theproduct that will protect the environment; and

State and Territorydepartments responsible for agriculturaland primary industries which evaluateand reports

on efficacy and target cropor animalsafety data fornew agricultural chemicalsandnew uses of registered

products. Insome cases theAPVMA contracts this workouttoother agencies such asuniversities, the CSIRO

ortoother experts.

Although all ingredients appear in theAustralianInventory of Chemical Substances(AICS), they havenotbeen

assessed byNICNAS(National Industrial Chemicals Notification and Assessment Scheme)

SECTION 16 OTHER INFORMATION

Dateoflastrevisionofthe MSDS:October2008

CONTACTPOINT Dr PaulRoss BVSc.

Phone: B/Hrs (07) 3808 1399

A/Hrs 0403 577 411

References:

1.FAISDHandbook, HandbookofFirstAidInstructions, SafetyDirections, WarningStatements,andGeneral

SafetyPrecautionsfor,Agricultural andVeterinaryChemicals, March2005

2.ApprovedCriteria For ClassifyingHazardous Substances, NOHSC:1008(2004)

3.National CodeofPracticefor thePreparationof Material SafetyData Sheets2 nd Edition[NOHSC:2011(2003)]

4.AICS(Australian InventoryofChemicalSubstances)

5.APVMA Manualof Requirements andGuidelines for Agricultural Chemicals, October2005

6.ADI[AcceptableDailyIntake]List, CommonwealthDepartmentofHealth&AgedCare,TGA,August2001

7.TheAustralian Codefor the TransportofDangerousGoodsbyRoadandRail(ADGCode)6 th Edition

8.HazardousSubstancesInformation System, Version1.2.2(September 2004), LastUpdated–November2005,

NOHSC

DISCLAIMER: All information given in this data sheet and by thecompany's technical staffiscompiled fromthe best informationcurrently

available to the company.The companyaccepts no responsibilitywhatsoever for its accuracyor for anyresults whichmay be obtained by

customers.Anycustomerwho relies upon anyadvice orinformation given in this data sheet bythe companyorbyits technical staff does so

entirely at its ownrisk,and the companywill not be liable foranyloss ordamage therebysuffered not withstanding anywantofcare on the part

of the company orits staff in compiling orgiving the advice orinformation.

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