PROGRAM TABLETS FOR MEDIUM DOGS

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

Buy It Now

Active ingredient:
LUFENURON
Available from:
Elanco Australasia Pty Ltd
INN (International Name):
lufenuron(204.9mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
LUFENURON AMINE/AMIDE Active 204.9 mg/Tb
Units in package:
6 Tablets
Class:
VM - Veterinary Medicine
Manufactured by:
ELANCO AUSTRALASIA
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
PARASITICIDES
Therapeutic indications:
FLEA | FLEA ALLERGIC DERMATITIS | CTENOCEPHALIDES SPP. | GROUND FLEAS
Product summary:
Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: DOG: [FLEA, FLEA ALLERGIC DERMATITIS]; For the prevention and lasting control of flea infestation and the treatment of flea allergic dermatitis in dogs weighing between 6.8 and 20 kg.
Authorization status:
Registered
Authorization number:
49650
Authorization date:
2020-07-01

Product name

Program Tablets for Medium Dogs:

Date

: Wednesday, 20 October 1999

Page

: 1 of 5

Pack sizes

6 tablets

Type of label

: Carton, Blister and Leaflet

File

: progmd1.doc

Version

: 2

Reason

: Trans-Tasman harmonisation

Text above this line is not included in the actual label.

Infopest verifies that this label is consistent with the NRA

Approved Text Label of 3/8/99 ________

Carton – Front panel

FOR ANIMAL TREATMENT ONLY

Program Tablets for Medium Dogs

Active Constituent: Each tablet contains 204.9 mg LUFENURON

Contents: 6 Tablets

For the prevention and lasting control of flea infestation and as an aid in the control of flea

allergic dermatitis in dogs weighing between 6.8 and 20 kg

NOVARTIS Animal Health Australasia Pty Limited,

ACN 076 745 198

140-150 Bungaree Road, Pendle Hill, NSW 2145

Licensed under the Animal Remedies Act 1967 No.6451

Licensed to Novartis New Zealand Limited, 43-45 Patiki Road, Avondale, Auckland .

Product name

Program Tablets for Medium Dogs:

Date

: Wednesday, 20 October 1999

Page

: 2 of 5

Pack sizes

6 tablets

Type of label

: Carton, Blister and Leaflet

File

: progmd1.doc

Version

: 2

Reason

: Trans-Tasman harmonisation

Text above this line is not included in the actual label.

Carton – Back panel

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

DIRECTIONS FOR USE

Administer one tablet monthly for dogs between 6.8 and 20 kg

PROGRAM

must be given with a

full

meal. Either give

within

the food or

immediately

afterwards. It is essential that all dogs and cats in the household (except unweaned puppies

or kittens), are treated for fleas with

PROGRAM.

For cats use

PROGRAM

suspension

(ARB No. 6452) and for dogs use

PROGRAM

tablets.

1.

Before fleas are seen on the dog.

For best results, start giving

PROGRAM

before flea activity is anticipated and

continue all year round.

2.

When dog is already infested with fleas.

PROGRAM

does not kill adult fleas. Where adult fleas are present, it will be

necessary to also treat the dog with a product registered for use against adult fleas,

until adult flea populations are reduced. Treatment with

PROGRAM

should also be

started at this time, and continued all year round. Treatment of the environment is also

recommended for severe flea infestations.

DISPOSAL:

Dispose of empty containers by wrapping with paper and putting in garbage.

STORAGE INSTRUCTIONS:

Store below 30

C (Room Temperature), away from direct sunlight. Store unused tablets in

the carton.

See end panel for batch and expiry information.

NRA 49650/0799

Product name

Program Tablets for Medium Dogs:

Date

: Wednesday, 20 October 1999

Page

: 3 of 5

Pack sizes

6 tablets

Type of label

: Carton, Blister and Leaflet

File

: progmd1.doc

Version

: 2

Reason

: Trans-Tasman harmonisation

Text above this line is not included in the actual label.

Carton - Top panel

NOVARTIS CUSTOMER ASSISTANCE

1800 633 768 TOLL FREE from anywhere in Australia

8.30am to 5.00pm E.S.T. Monday to Friday

PET OWNERS INFORMATION

0800 588 001 TOLL FREE from anywhere in New Zealand

10.30am to 7.30pm Monday to Friday

Carton – Bottom panel

Program 6 Tablets

For dogs between 6.8 and 20 kg

Carton – Side Panel 1

PROGRAM

6 Tablets

Blister

FOR ANIMAL TREATMENT ONLY

PROGRAM

Lufenuron 204.9 mg

Novartis Animal Health Inc.

Exp.

Product name

Program Tablets for Medium Dogs:

Date

: Wednesday, 20 October 1999

Page

: 4 of 5

Pack sizes

6 tablets

Type of label

: Carton, Blister and Leaflet

File

: progmd1.doc

Version

: 2

Reason

: Trans-Tasman harmonisation

Text above this line is not included in the actual label.

Leaflet

FOR ANIMAL TREATMENT ONLY

PROGRAM Tablets

DIRECTIONS FOR USE

Dose

instructions

Size of dog

treated

Dose

(tablets/month)

Up to 6.7 kg

1 Red Tablet

6.8 - 20 kg

1 Brown Tablet

20.1 - 40 kg

1 Cream Tablet

Over 40.1 kg

Appropriate combination

of tablets

according to dog's weight

Important:

PROGRAM Tablets

must be given with a

full

meal. Either give

within

the food or

immediately

afterwards.

Before fleas are seen on the dog.

For best results, start giving

PROGRAM Tablets

before flea activity is anticipated and

continue all year round.

2.

When a dog is already infested with fleas

PROGRAM Tablets

do not kill adult fleas. Where adult fleas are present, it will be

necessary to also treat the dog with a product registered for use against adult fleas, until

adult flea populations are reduced. Treatment with

PROGRAM Tablets

should also be

started at this time, and continued all year round. Treatment of the environment is also

recommended for severe flea infestations.

General Information

PROGRAM Tablets

have been specifically developed as a monthly oral treatment for the

control of fleas on dogs.

Product name

Program Tablets for Medium Dogs:

Date

: Wednesday, 20 October 1999

Page

: 5 of 5

Pack sizes

6 tablets

Type of label

: Carton, Blister and Leaflet

File

: progmd1.doc

Version

: 2

Reason

: Trans-Tasman harmonisation

Text above this line is not included in the actual label.

PROGRAM

is taken in by adult fleas when they bite the treated dog. Eggs subsequently

laid by these fleas will not hatch. As a result the normal build up of the flea population on

the dog and in the immediate environment is stopped.

To control the flea population it is essential that all dogs and cats in the household, (except

unweaned puppies or kittens), are treated for fleas with

PROGRAM.

For cats use

PROGRAM

suspension (ARB No. 6452) and for dogs use

PROGRAM

tablets.

Flea Allergic Dermatitis (FAD)

Flea allergic dermatitis (commonly known as “summer eczema”) is one of the most

common skin diseases of dogs and cats. Affected animals suffer from an allergy to the bite

of fleas which causes inflamed skin, hair loss and excessive itching/scratching. By reducing

the number of fleas in the pet’s environment to a negligible level, the symptoms of flea

allergic dermatitis are controlled by

PROGRAM Tablets

This effect of

PROGRAM

Tablets

is not instantaneous and several months of continuous

treatment may be necessary before control is achieved.

Disposal

Dispose of empty containers by wrapping with paper and putting in garbage.

Storage Instructions

Store below 30

C (Room Temperature), away from direct sunlight. Store unused tablets in

the carton.

Warranty

The manufacturer of this animal remedy extends/grants to the purchaser a warranty that this

animal remedy is reasonably fit for the purposes for which its use is recommended,

provided that the purchaser uses the remedy only for the purposes for which it is

recommended him and strictly in accordance with the directions on this container.

® Registered trademark of Novartis Inc., Basle, Switzerland

Novartis Animal Health Australasia Pty Limited, A.C.N. 076 745 198

140-150

Bungaree Road, Pendle Hill, NSW 2145

Licensed under the Animal Remedies Act 1967 No. 6451

Licensed to Novartis New Zealand Limited, 43-45 Patiki Road, Avondale, AUCKLAND .

NRA 49651/0799, 49650/0799, 49649/0799

ProductName: PROGRAM® Tabletsfor Medium

Dogs

Page: 1 of 5

SAFETY DATASHEET

Issued by: Novartis Animal Health Australasia PtyLtd. Phone: 02 9805 3555 (office hours)

SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER

Novartis Animal Health Australasia PtyLtd. ABN 64 076 745 198 Telephone 02 9805 3555 (office hours)

54 Waterloo Rd Fax 02 9888 8387

North Ryde, NSW 2113

Chemical nature: Lufenuron isa benzoylureaderivative.

Trade Name: PROGRAM ®

Tablets for Medium Dogs

Product Use: For the prevention and lasting control of flea infestation and asan aid in the control of

flea allergicdermatitis by once a month oral dose to dogsweighingbetween 6.8and

20 kg.

Creation Date: August, 2013

This version issued: August, 2013and is valid for 5 years from this date.

SECTION 2 - HAZARDS IDENTIFICATION

STATEMENT OF HAZARDOUS NATURE

This product isclassified as: N, Dangerousto the environment. Notclassifiedashazardousaccording to the

criteria of SWA.

Not a Dangerous Good according to theAustralian DangerousGoods (ADG) Code.

Risk Phrases: R52. Harmful to aquatic organisms.

SafetyPhrases: S25, S61. Avoid contact with eyes. Avoid release to the environment. Refer to

special instructions/Safety Data Sheets.

SUSMP Classification: Noneallocated.

ADG Classification: Noneallocated. Not a Dangerous Goodunder the ADG Code.

UN Number: Noneallocated

GHS Signal word: NONE. Not hazardous.

HAZARD STATEMENT:

H402: Harmful to aquatic life.

PREVENTION

P102: Keep out of reach of children.

RESPONSE

P353: Rinseskin orshowerwith water.

P301+P330+P331: IF SWALLOWED: Rinsemouth.Do NOT induce vomiting.

P332+P313: If skin irritationoccurs: Getmedical advice.

P337+P313: If eye irritationpersists: Get medical advice.

P391: Collectspillage.

P370+P378:Not combustible. Use extinguishing media suited to burning materials.

STORAGE

P402+P404:Store in a dryplace. Store ina closedcontainer.

DISPOSAL

P501: Dispose of small quantities and empty containersbywrapping with paper and putting ingarbage. For

largerquantities, if recycling or reclaimingis notpossible, use acommercial waste disposalservice.

EmergencyOverview

Description &Colour : Dark grey-violet, round, slightly biconvexfilm tablets.Weighs 710mg

Odour: No odour.

Major HealthHazards: no significantrisk factors have been found for this product.

Potential Health Effects

INHALATION:

Short TermExposure: Available data indicates that this product is not harmful. However product may be

mildly irritating, although unlikely to cause anything more thanmild transient

discomfort.

Long Term Exposure: No data for health effectsassociatedwith long term inhalation.

ProductName: PROGRAM® Tabletsfor Medium

Dogs

Page: 2 of 5

SAFETY DATASHEET

Issued by: Novartis Animal Health Australasia PtyLtd. Phone: 02 9805 3555 (office hours)

SKIN CONTACT:

Short TermExposure: Available data indicates that this product is not harmful. It should present no hazards

in normal use.However product may be irritating, but is unlikely to cause anything

more than mild transient discomfort.

Long Term Exposure: No data for health effectsassociatedwith long term skin exposure.

EYE CONTACT:

Short TermExposure: This product may be irritating to eyes, butis unlikely to cause anything more than

mild transientdiscomfort.

Long Term Exposure: No data for health effectsassociatedwith long term eye exposure.

INGESTION:

Short TermExposure: Significant oral exposure isconsideredtobe unlikely. However, this product may be

irritating to mucous membranes but is unlikely tocauseanythingmore than transient

discomfort.

Long Term Exposure: No data for health effectsassociatedwith long term ingestion.

CARCINOGEN STATUS:

SWA: No significantingredient is classified ascarcinogenicby SWA.

NTP: No significantingredient is classified ascarcinogenicby NTP.

IARC: No significantingredient is classified ascarcinogenicby IARC.

SECTION 3 - COMPOSITION/INFORMATION ON INGREDIENTS

Ingredients CAS No Conc,% TWA (mg/m 3 ) STEL (mg/m 3 )

Lufenuron 103055-07-8204.9mg/tab not set not set

Other non hazardous ingredients secret to 100 not set not set

Note: each tablet weighs 710mg

This isa commercial product whose exact ratio of components may vary slightly. Minor quantities of other non

hazardousingredients arealso possible.

The SWA TWA exposure value is the averageairborne concentration of a particular substance whencalculated over a normal 8 hourworkingday

for a 5 dayworkingweek. The STEL (ShortTermExposure Limit) isan exposure value that maybeequalled (but should not be exceeded) forno

longer than 15minutes and should not be repeated more than4 timesper day. There should be at least 60 minutes between successive exposures

at the STEL.Theterm "peak "is used when theTWA limit, becauseof the rapid action of the substance, should never be exceeded, even briefly.

SECTION 4 - FIRST AID MEASURES

GENERAL INFORMATION:

You should call The Poisons Information Centre if youfeel that you may have been poisoned, burned orirritated by

this product. The number is13 1126 fromanywhere inAustralia (0800 764 766 inNew Zealand) and is available at all

times.Have thisSDS withyou when you call.

Inhalation: First aid isnot generally required. If in doubt, contact a Poisons Information Centre or

a doctor.

Skin Contact: Gentlybrush awayexcess particles. Washgently andthoroughly with water (usenon-

abrasive soapif necessary) for 5 minutes or until chemical isremoved.

Eye Contact: Quickly and gently brush particles fromeyes. No effects expected.If irritation does

occur, flush contaminatedeye(s) with lukewarm, gently flowing water for 5 minutes or

until the product is removed. Obtain medical advice ifirritation becomes painfulor

lasts more than a few minutes. Take specialcare if exposedperson is wearing

contact lenses.

Ingestion: If product is swallowed orgets in mouth,do NOT inducevomiting; washmouthwith

water and givesomewater to drink.If symptoms develop, or if in doubt contact a

Poisons Information Centre or a doctor.

SECTION 5 - FIRE FIGHTING MEASURES

Fire and Explosion Hazards: The major hazard in firesis usually inhalation of heated and toxicor oxygen deficient

(or both), firegases. Thereis no risk of anexplosion from this product under normal

circumstances if it is involved in a fire.

Fire decomposition products from this product may be toxic if inhaled. Take appropriate protective measures.

Extinguishing Media: In case of fire, use carbondioxide, dry chemical, foam, water fog.

Fire Fighting: If a significantquantity of this product isinvolved in a fire, call the fire brigade.

Flash point: No data

Upper FlammabilityLimit: No data.

Lower FlammabilityLimit: No data.

Autoignitiontemperature: No data.

ProductName: PROGRAM® Tabletsfor Medium

Dogs

Page: 3 of 5

SAFETY DATASHEET

Issued by: Novartis Animal Health Australasia PtyLtd. Phone: 02 9805 3555 (office hours)

Flammability Class: No data.

SECTION 6 - ACCIDENTAL RELEASE MEASURES

Accidental release: This product is soldin small packages,and the accidental release from one of these

is not usually a cause forconcern. Forminorspills, clean up, rinsing to sewer and put

empty container in garbage. Although nospecial protective clothingis normally

necessary because of occasional minor contact with this product, it is good practice to

wearimpermeable gloveswhenhandling chemical products. In the event of a major

spill, prevent spillage fromentering drainsorwatercourses and callemergency

services.

SECTION 7 - HANDLING AND STORAGE

Handling: Keep exposure to this product to a minimum, and minimise the quantities kept in

work areas. Check Section 8 of this SDS for details ofpersonal protective measures,

and make sure that thosemeasures arefollowed. The measures detailed below

under "Storage" should be followed duringhandling inorder to minimise risks to

personsusing the productin the workplace.Also, avoid contact or contamination of

product with incompatiblematerials listed in Section 10.

Storage: Makesure that containers of this productare kept tightly closed. Keep containers dry

and away fromwater. Make sure that theproduct doesnot come into contact with

substances listed under "Incompatibilities"in Section 10. Check packaging - there

may be further storage instructionson the label.

SECTION 8 - EXPOSURE CONTROLSAND PERSONAL PROTECTION

The followingAustralian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment:AS/NZS 1715, Protective Gloves:AS 2161, OccupationalProtective Clothing: AS/NZS 4501

set 2008, Industrial Eye Protection:AS1336andAS/NZS 1337, Occupational Protective Footwear:AS/NZS2210.

SWA Exposure Limits TWA (mg/m 3 ) STEL (mg/m 3 )

Exposure limits have not been established by SWA for anyof the significant ingredients in this product.

The ADI for Lufenuron isset at 0.02mg/kg/day. ThecorrespondingNOEL issetat 2.1mg/kg/day. ADI means

AcceptableDaily Intake; NOEL meansNo-observable-effect-level.Data from Australian ADIList, Dec 2012.

No special equipment is usually neededwhenoccasionallyhandlingsmall quantities. The following instructions are

for bulk handling or where regularexposure in an occupational setting occurswithout propercontainment systems.

Ventilation: No special ventilation requirements arenormally necessary for thisproduct. However

makesure that the work environment remainsclean and that dusts are minimised.

Eye Protection: Eye protection such asprotective glassesor goggles isrecommended when this

product is being used.

Skin Protection: You shouldavoid contacteven with mild skin irritants. Therefore you should wear

suitable impervious elbow-length glovesand facial protection whenhandling this

product. Seebelowfor suitable materialtypes.

ProtectiveMaterial Types: There is nospecificrecommendation for anyparticular protective material type.

Respirator: If there is a significant chance that dusts are likely to build up in the areawherethis

product is being used, we recommend that you use asuitableDust Mask.

SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES:

Description &colour: Dark grey-violet, round, slightly biconvexfilm tablets.Weighs 710mg

Odour: No odour.

Boiling Point: Not applicable.

Freezing/Melting Point: Decomposes before melting.

Volatiles: No specific data. Expectedto be low at 100°C.

Vapour Pressure: Negligible at normal ambient temperatures.

Vapour Density: Not applicable.

Specific Gravity: No data.

Water Solubility: Disintegratesslowly in water.

pH: No data.

Volatility: Negligible at normal ambient temperatures.

Odour Threshold: No data.

Evaporation Rate: Not applicable.

Coeff Oil/water Distribution: No data

Viscosity: Not applicable.

ProductName: PROGRAM® Tabletsfor Medium

Dogs

Page: 4 of 5

SAFETY DATASHEET

Issued by: Novartis Animal Health Australasia PtyLtd. Phone: 02 9805 3555 (office hours)

Autoignition temp:No data.

SECTION 10 - STABILITY AND REACTIVITY

Reactivity: This product is unlikely to react ordecompose undernormal storage conditions.

However, if you have anydoubts, contact the supplier for advice onshelf life

properties.

Conditions to Avoid: Keep containers tightly closed. Containersshould bekept dry.

Incompatibilities: water, strongacids, strongbases, strongoxidising agents.

Fire Decomposition: Combustionformscarbondioxide, and ifincomplete,carbon monoxide and possibly

smoke. Water is also formed. Carbon monoxide poisoning produces headache,

weakness, nausea, dizziness, confusion,dimness of vision, disturbance of judgment,

and unconsciousness followed by comaand death.

Polymerisation: This product will not undergopolymerisation reactions.

SECTION 11 - TOXICOLOGICAL INFORMATION

LOCAL EFFECTS:

Target Organs: There is nodata to hand indicating anyparticular target organs.

Lufenuron isClassed by SWA as a potential sensitiserby skin contact.

Acute Toxicity :

Oral : Technical Lufenuron, givenorally LD

>5000 mg/kg (rat, mouse).Low toxicity.

Dermal: Technical Lufenuron, dermal LD

> 2000 mg/kg (rat).Low toxicity.

Inhalation: Technical Lufenuron, LC

(4 h)>2350 mg/m 3 Low toxicity.

Local Effects: Irritation – (Basedon studies withrabbits)

Skin: Non-irritant.

Eyes: Non-irritant.

Sensitisation:(Based onresults on guinea-pigs)

Skin:Non-sensitiser

Chronic Toxicity: Lufenuron hasbeen testedon laboratorymammals andin test-tubesystems. No

evidence of mutagenic, carcinogenic, teratogenic orreproductiveeffects was

obtained.

SECTION 12 - ECOLOGICAL INFORMATION

Toxic to aquatic organisms, may cause long-term adverse effects to the aquaticenvironment.

Ecological data for Lufenuron

Species LC

50 mg/L EC

50 mg/L LD

50 (Oral), Rat(mg/kg)

Trout (96 hrs) >100 -

Bluegill sunfish (96 hrs) >100 -

Daphnia magna (48 hrs) 0.011-0.013

Green algae (3 days) 100

Eisenia foetida - Earthworm(14 d) 1000

Mallard duck 2000

Bobwhite quail 2000

Apis mellifera L. [Honey-bee] (24h) Oral 380μg/bee

Contact 80μg/bee

Lufenuron istoxic to aquaticarthropodsbut practicallynon-toxic to fish, birds andadult bees.

SECTION 13 - DISPOSAL CONSIDERATIONS

Disposal: Dispose of small quantities and empty containers bywrappingwith paper andputting

in garbage. For larger quantities, if recycling orreclaiming is not possible, use a

commercial waste disposalservice.

SECTION 14 - TRANSPORT INFORMATION

ADG Code: Thisproduct isnotclassifiedasaDangerousGood. Nospecial transportconditions

are necessary unless required by other regulations.

SECTION 15 - REGULATORY INFORMATION

AICS: All of the significant ingredients in thisformulation are compliant with NICNAS

regulations.

ProductName: PROGRAM® Tabletsfor Medium

Dogs

Page: 5 of 5

SAFETY DATASHEET

Issued by: Novartis Animal Health Australasia PtyLtd. Phone: 02 9805 3555 (office hours)

SECTION 16 - OTHER INFORMATION

This SDS contains onlysafety-relatedinformation.For other data see product literature.

Acronyms:

ADG Code Australian Code for the Transport of Dangerous Goods by Roadand Rail (7 th edition)

AICS Australian Inventory of Chemical Substances

SWA Safe WorkAustralia, formerlyASCC and NOHSC

CAS number Chemical Abstracts Service Registry Number

HazchemCode Emergency action code ofnumbers andlettersthat provide information to emergency

servicesespecially firefighters

IARC International Agency forResearch onCancer

NOS Not otherwisespecified

NTP National Toxicology Program (USA)

R-Phrase Risk Phrase

SUSMP Standard for the Uniform Scheduling ofMedicines & Poisons

UN Number United Nations Number

Contact Point: RegulatorAffairs Manager –Animal Health Division– 02 98053555

THIS SDS SUMMARISES OURBEST KNOWLEDGEOFTHE HEALTHAND SAFETYHAZARDSTATEMENT:INFORMATIONOFTHE

PRODUCT ANDHOW TOSAFELYHANDLE ANDUSE THE PRODUCT INTHE WORKPLACE. EACH USER MUSTREVIEW THIS SDS IN THE

CONTEXTOFHOW THE PRODUCT WILL BE HANDLED ANDUSED IN THE WORKPLACE.

IF CLARIFICATIONORFURTHER INFORMATION IS NEEDED TOENSURETHATAN APPROPRIATE RISK ASSESSMENT CANBE MADE,

THE USER SHOULD CONTACTTHIS COMPANY SOWE CAN ATTEMPT TOOBTAIN ADDITIONALINFORMATION FROMOUR SUPPLIERS

Please read all labels carefully before using product.

This SDS isprepared inaccord withthe SWA document “Preparation ofSafety DataSheets for Hazardous

Chemicals - Code of Practice” (December 2011)

Copyright ©Kilford & Kilford Pty Ltd, August, 2013.

http://www.kilford.com.au/ Phone (02)9251 4532

Similar products

Search alerts related to this product

View documents history

Share this information