STARTGARD FOR PUPPIES

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

Buy It Now

Active ingredient:
IVERMECTIN; PYRANTEL AS PYRANTEL EMBONATE; FIPRONIL
Available from:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
INN (International Name):
fipronil(100g/L)+ivermectin(68ug/Ch)+pyrantel as pamoate(57mg/Ch)
Pharmaceutical form:
ORAL CHEWABLE + TOPICAL CREAM,OINTMENT,PASTE,GEL
Composition:
IVERMECTIN ANTHELMINTIC Active 68.0 ug; PYRANTEL AS PYRANTEL EMBONATE ANTHELMINTIC Active 57.0 mg; FIPRONIL NITRILE Active 100.0 g/L
Units in package:
1 Tablet +; 1 x 0.67mL
Class:
VP - Veterinary Pesticide
Manufactured by:
MERIAL AUSTRALIA
Therapeutic group:
DOG | DOG - WITH EXCLUSIONS SEE LABEL | BITCH | CASTRATE | PUPPY
Therapeutic area:
PARASITICIDES
Therapeutic indications:
BROWN DOG TICK | CAT FLEA | HEARTWORM - LARVAE | HOOKWORM | HOOKWORM - ANCYLOSTOMA CANINUM | HOOKWORM - UNCINARIA STENOCEPHALA | PARALYSIS TICK | ROUNDWORM - TOXASCARIS LEONINA | ROUNDWORM - TOXOCARA CANIS | ANCYLOSTOMA BRAZILIENSE | ANCYLOSTOMA CANINUM | ASCARID | AUSTRALIAN PARALYSIS TICK | DOG TICK | HUMAN INTESTINAL ROUNDWORM | SCRUB TICK | UNCINARIA STENOCEPHALA
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [HEARTWORM - LARVAE, HOOKWORM, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - UNCINARIA STENOCEPHALA, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS]; DOG - WITH EXCLUSIONS SEE LABEL: [BROWN DOG TICK, CAT FLEA, PARALYSIS TICK]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [HEARTWORM - LARVAE, HOOKWORM, HOOKWORM - ANCYLOSTOMA CANINUM, HOOKWORM - UNCINARIA STENOCEPHALA, ROUNDWORM - TOXASCARIS LEONINA, ROUNDWORM - TOXOCARA CANIS]; DOG - WITH EXCLUSIONS SEE LABEL: [BROWN DOG TICK, CAT FLEA, PARALYSIS TICK]; For use by veterinarian as initial treatment for fleas, ticks, ascarids and hookworms and to prevent heartworm disease.DO NOT USE ON PUPPIES UNDER 3 MONTHS OF AGE. See Safety/Precautions sections on leaflet also.
Authorization status:
Registered
Authorization number:
51304
Authorization date:
2019-07-01

30/O?

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9 8 9 3

0008

MERIAL AIJSTRALIA

@loo5

STARTGARD FOR PUPPIES

CARTON

PAGE:

1 of 13

DATE:

SEPTEMBER

1998

DRAFT; 3

PANEL: FRONT

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

STARTGARDTM

for PUPPIES

Contents:

FRONTLINE@

Top Spot Small Dog

contains:

100 g/L

FIPRONIL (one 0.67 ml

pipette)

For dogs weighing up to 10 kg

HEARTGARDaW

Plus

(Svermectinlpyrantel)

Chewable

Contains:

IVERMECTIN

and 57 mg PYRANTEL (as embonate salt) (in

one chewable)

For dogs weighing up to

For use by veterinarians as initial treatment for fleas, ticks, ascarids

and hookworms and to prevent heartworm disease.

READ ENCLOSED LEAFLET BEFORE USING PRODUCT.

PROFESSIONAL VETERINARY SAMPLE ONLY - NOT FOR SALE

TM

STARTGARD is a trademark of Merial Limited

Q

FRONTLINE

HEARTGARD are registered trademarks of Merial Limited.

APPROVE

Label No:

Date:

Signature:

1st line to be at least

half the height of

STARTGARD and

in

bold. Next 3 lines: bold

& at least four-tenths of

the height of 1

line

,R.A.

LABEL(TEXT)

30/-0.9

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STARTGARD FOR PUPPIES

CARTON

PAGE: 2 of 13

DATE: 30 SEPTEMBER 1998

DRAFT: 3

PANEL:

BACK

FRONTLINE@

Top Spot

Small Dog:

For the treatment and prevention of

flea

(Ctenocepha/ides~e/js)

and tick

Jincluding

lxodes

hdocyclus)

infestations on dogs weighing up to 10 kg.

Water fast, monthly

flea

treatment, two weekly Paralysis Tick treatment.

SAFETY DIRECTIONS

(for

FRONTLINE Topspot): Will irritate eyes

and skin. Avoid contact with eyes and skin. If product gets in eyes, wash

it out immediately with water. Wash hands after use.

FIRST AID (For FRONTLINE Top Spot): If poisoning occurs, contact

a

doctor or Poison Information Centre. If swallowed, and if more than 15

mintues from a hospital, induce vomiting, preferably using Ipecac Syrup

APF.

l-lEARTGARD3m

Plus

(ivermectin/pyrantel)

Chewable:

For use in dogs to prevent canine heartworm disease and for monthly

treatment and control of

ascarids

and hookworms. Recommended for

dogs up to 11 kg bodyweight. Treat once a month to prevent heartworm

disease in dogs.

NRA Approval Number: 51034

\oqg

Batch Nos: FRONTLINE Top Spot:

Expiry Date:

HEARTGARD Plus:

Store below

30°C

(Room Temperature)

(LOGO)

Merial

Australia Pty Limited

A.C.N. 071 187 285

Level 6,79 George Street

Parramatta NSW 2150

G:!REGAFN.ABELSiHEARTG-lBTARTPUl.DGC

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PAGE: 3 of 13

STARTGARD’FOR PUPPIES

INSERT

30 SEPTEMBER 1998

DRAFT: 3

SIDE ONE

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

WEARTGARDJW

Plus

(ivermectinlpyrantel)

Chewables

INDICATIONS:

For use in dogs to prevent canine heartworm disease by eliminating the tissue

stage of heartworm

larvae

(OirMaria

immitis)

that infected the dog in the month

(30 days) after treatment and for the treatment and control of

ascarids

(Toxocara

canis

Toxascatis

leonine)

and hookworms

(Ancylostoma

caninum,

A.

braziliense

Uncinaria

stenocephala).

DOSAGE:

HEARTGARDSO

Plus Chewables are to be administered orally at the

recommended minimum dose level of 6.0

ivermectin and

pyrantel per

kilogram of bodyweight at monthly dosing intervals (See ADMINISTRATION).

The recommended dosage schedule for prevention of canine heartworm

disease is as follows:

Chewables

Ivem~ectin

I

I

Pyrantel

I

product

Do0

wehlht

PerMonth

COMWtt

COntent

Mmlber

Uptoll

kg

1

88

vg

57mg

37811

(AU)

12to22kg

1

138w

114mg

37812(AU)

23to48kg

1

272

pg

227

37813(AlJ)

Colour

Coding

Carton

Blue

Green

Brown

Give dogs over

45

kg the appropriate

comblnatlon

of these Chewables.

HEARTGARD30 Plus is recommended for use in dogs 6 weeks of age

and older.

ADMINISTRATION:

Remove

only one chewable

at a

time from the foil-backed blister card.

Return

the card with the remaining

ohewables

to its box to protect the product from

light.

Because most dogs find

HEARTGARD-30

Plus palatable, they can be

offered to the dog by hand. Alternatively, they may be added to a small amount

of dog food.

The chewable should be administered in a manner that

encourages the dog to chew, rather than to swallow without chewing.

Chewables may be broken into pieces and fed to dogs that normally swallow

treats whole.

Care should be taken to ensure that the dog consumes the complete dose, and

treated animals should be observed for a few minutes after administration to

ensure that part of the dose is not lost or rejected.

If’lt

is suspected that any of

the dose has been lost,

redosing

Is recommended.

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STARTGARD FOR PUPPIES

INSERT

PAGE: 4

of 13

SEPTEMBER

1998

__-.

DRAFT:

SIDE ONE (CONTINUED)

HEARTGARD-30

Pius Chewables should be given at monthly intetvak

during

the period of the year when mosquitoes (vectors) potentially

carrying

infective

heartworm larvae are active.

The initial dose must be given within one month

days) after the first exposure to mosquitoes. The final dose must be given

within a month (30 days) after the dog’s last exposure to

mosquitoes.

When replacing another heartworm preventive product in a heartworm disease

preventive programme, the first dose of HEARTGARD30 Plus must be given

within a month (30 days) of the last dose of the former medication.

If the interval between doses exceeds a month (30 days), the efficacy of

ivermectin can be reduced. Therefore, for optimal performance,

HEARTGARD-30 Plus must be given once a month on or about the same

date. If treatment is delayed, whether by a few days or many, immediate

fieatment

with HEARTGARD30 Plus and resumption of the recommended

dosing regimen will minimise the opportunity for the development of adult

heartworms. Monthly treatment with HEARTGARD-30 Plus also provides

effective treatment and control of ascarids

canis

T.

leonina)

hookworms (A. caninum, A

braziliense

stenocephala).

EFFICACY;

HEARTGARD-30 Plus Chewables, given orally using the recommended dose

and regimen, are effective against the tissue larval stage of

Dirofilatia

immfiis

acquired during the previous month (30 days) and, as a result, prevent the

Uevelopment

the adult stage.

HEARTGARO-30

Plus Chewables are also

effective against canine ascarids (T.

canis

T.

leonina)

and hookworms

(A. caninum, A braziliense and

stenocephala).

ACCEPTABILITY:

In acceptability and field trials,

HEARTGARD-30

Plus Chewables were shown to

be a palatable oral dosage

form

which will be consumed at the first offering by

the majority of dogs.

SAFETY:

Clinical studies with HEARTGARD-30 Plus

(ivermectin/pyrantel)ChewaMes

have shown a wide safety margin at the recommended dose level in dogs of

breeds including pregnant and breeding bitches, stud dogs and puppies aged

six or more weeks. In clinical field trials, many commonly used flea collars, dips,

shampoos, anthelmintics, antibiotics, vaccines and steroid preparations have

been administered with HEARTGARD-30 Plus in a

heartwomr

preventive

programme.

PRECAUTIONS:

Dogs should be tested for existing heartworm infection prior to starting treatment

with HEARTGARD-30 Plus which is not effective against adult D.

immitis.

Infected dogs should be treated to remove adult heartworm and microfilariae

prior to initiating a programme with HEARTGARD30 Plus,

So/@

‘ O S

W E D

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F A X

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STARTGARD FOR

lNSERT

MERIAL AUSTRALIA

PUPPIES

PAGE: 5 of

DRAFT: 3

SIDE ONE (CONTINUED)

@loos

30 SEPTEMBER

IQ98

Treatment with

HEARTGARD-30

Plus may reduce the number of

Circ&tting

microfilariae to levels that are undetectable. A mild

hypersensitivityreaction,

presumably due to dead or dying microfilariae and particularly involving a

transient

diarfhoea,

has been observed in clinical

trials

after treatment of some

dogs that have circulating microfilariae.

TOXICOLOGY:

The

target dose of ivermectin in HEARTGARD30 PLUS (6

ugn<g)

has a wide

margin of safety. However, administration of high doses from formulations

indicated for use in other species has resulted in adverse reactions in certain

dogs, particularly of the Collie breed.

Reactions seen in sensitive Collies at

ivermectin/kg

body weight and above include mydriasis, depression,

ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma and

death, Mild and transitory ataxia and depression were observed in sensitive

Collies treated at 100

ug/kg.

However, ivermectin treatment at ten times the

target dose of

HEARTGARDSO

PLUS has been shown to cause no reactions

in sensitive Collies.

In cases of toxicity, symptomatic or supportive treatment

is recommended.

PACKAGE INFORMATION:

HEARTGARD-30 Plus is available in three dosage strengths (see

DOSAGE

section)

for dogs of different weights.

Each strength comes

in convenient cartons of 6

chewable&

packed 10 cartons per tray.

STORAGE:

Store below 30°C (Room Temperature). Do not freeze. Protect from

light.

(LOGO)

Merial Australia Pty Limited

A.C.N. 071 187 285

Level

6,79

George Street

Parramatta NSW 2150

For product information and for emergency advice call the

24-hour

toll-free

Merial technical hotline

1800-808-691.

NRA Approval Number:

51034/

HEARTGARD

is

nrgistered

trademark of

M&al

Lfmibj.

Qblerial

Liiited,

1998.

All

t$hts

rtmtwved.

MWbl

Limited.

Registered in England and Wales (NO. 3332751) with registered

offices

at

27

KMhtsbMge,

London. SWIX

7QT,

England, end

dctmeskated

in Delaware, USA

as

Merial UC.

G:UtEGAFFiLABELSUfEhRTG-IKTARTPUl

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PAGE: 6

13

DRAFT:

STARTGARD FOR PUPPIES

INSERT

SIDE

-IWO

@lo10

30 SEPTEMBER 1998

CAUTION

KEEP OUT OF REACH

OF

CHILDREN

READ SAFETY

DIRECTIONS

FOR ANIMAL TREATMENT ONLY

MERIAL

Logo

FRONTLINE@

(fipronil)

TOP SPOT SMALL DOG

DIRECTIONS FOR USE:

DO NOT USE ON

PliPPlES

UNDER 3 MONTHS OF AGE.

Break the snap-off top from the pipette along the scored line.

Part the coat

until the skin is visible. Choose an area where licking can not occur e.g.

between the shoulder blades.

Place the tip of the pipette on the skin and

squeeze several times to empty its contents directly on to the skin.

Care

should be taken to avoid excessive wetting of the hair as this will cause a

sticky appearance of hairs at the treatment spot.

However, if this should

occur, it will disappear within 24 hours after application

Fleas

(Cfenocephalicfes

fek):

For the treatment and prevention of fleas

for one month for dogs weighing up to

kg bodyweight apply the entire

contents of one pipette of 0.67

Frontline’t’op

Spot Small Dog to

dog as directed. For ongoing flea control it is recommended to

Frontline

Top Spot Small Dog

monthly.

Paralysis Tick

(Ixodes

ho/ocyc/us):

For prevention of Paralysis Tick

infestations for up to 2 weeks for dogs weighing up to 10 kg bodyweight

apply the entire contents of one pipette of 0.67

FrontlineTop

Spot

Small Dog

to the dog as directed. Immediately prior to treatment and

during the Paralysis Tick season daily searching for Paralysis Ticks is

strongly recommended.

Brown Dog Tick

(Rhipicephalussanguirreus):

For the treatment and

prevention of Brown Dog Ticks for up to 1 month for dogs weighing up to

10 kg bodyweight apply the entire contents of one pipette of 0.67

Frontline Top Spot Small Dog

to the dog as directed.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER,

CONTRARY TO THIS LABEL UNLESS

AUTHORISED

UNDER

APPROPRIATE

LEGISLATION.

Further

Information:

It is not recommended to bath or shampoo the

animal during the 48 hours before and after treatment with Frontline Top

Spot Small Dog,

The product will spread over the coat of the animal within

24 hours. Once spread

Frontline Top Spot Small Dog

is water fast and

regular water immersions will not adversely affect its activity.

Frontline

Spot Small Dog

does not prevent all ticks from attaching to the

animals, but ticks will be killed within the first 24-48 hours after attachment.

Once dead, ticks will normally drop off the animal, but any remaining ticks

may be easily removed by a gentle pull.

ao/o.a

'98 WED

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MERIAL

AUSTRALIA

PAGE: 7 of 13

DRAFT: 3

STARTGARD

FOR

PUPPIES

INSERT

SIDE TWO (CONTINUED)

The

action of

Frontllne

Top Spot

Small Dog

can be assisted by

conducting environmental flea control procedures. Treat all cats and dogs

in the household.

SAFETY DIRECTIONS:

Will

irritate the eyes and skin. Avoid contact with

eyes and skin.

If product enters eyes, wash it out immediately with water.

Wash hands after use.

FIRST AID:

If poisoning occurs, contact a doctor or Poison Information

Centre. If swallowed, and if more than

mintues from a hospital, induce

vomiting, preferably using Ipecac Syrup APF.

Storage:

Store below

30”C’(Room

Temperature).

Disposal;

Wrap empty container in paper and place in garbage.

Picture

Graphic

2. Picture

Graphic

3. Picture

Graphic

shoulder blades

Remove

a

pipette from the foil backed holder.

Break off the tip of the pipette at the pre-cut line.

Apply the entire contents at a point between the

4. Picture

Graphic

Part the coat so the contents can be applied directly

to the skin when the pipette is squeezed.

FRONTLINE TOP SPOT SMALL DOG

@

FRONTLINE

and HEARTGARD are registered trademarks of

Merial

Limited.

@lo11

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STARTGARD

PU

PPIES

CARTON

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PAGE: 8 of 13

DATE: 30 SEPTEMBER 1998

DRAFT: 3

TOP

FLAP

STARTGARDTMfor

PUPPIES

CdREGAFFiLABELSiHEh-

I

ISTARTPU

1

.tXIC

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08 FAX

2 9893 0098

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STARTGARD FOR PUPPIES

CARTON

@lo13.

PAGE:

13

DATE:

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DRAFT: 3

PANEL:

LHS/RHS

STARTGARDTMfor

PUPPIES

3OfO.O

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a014

STARTGARD FOR PUPPIES

HEARTGARD Plus

Chewables (68 pg)

DISPENSING BLISTER

PAGE: 10 of 13

DRAFT: 3

PANEL:

FRONT

FOR ANIMAL

TREATMENT

ONLY

WARTGARD3W

PIUS

(ivermectin/pyrantel)Chewables

Each Chewable contains 68

IVERMECTIN

!7mg

PYRANTEL (as embonate salt)

For use in dogs to prevent heartworm disease and for treatment and

control of ascarids and

hoolcworrn.

Recommended for dogs up to 11 kg bodyweight

Batch Number:

Expiry Date:

Store below

30°C

(Room Temperature). Do not freeze. Protect from

light.

Product 37811 (AU)

30 SEPTEMBER 1998

G:iREGAFFU_N3ELSiHEARTG-l\STARTPUl.DOC

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MERIAL AUSTRALIA

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STARTGARD FOR PUPPIES

(FRONTLINE TOP SPOT SMALL DOG)

PAGE: 11 of 13

30 SEPTEMBER 1998

DRAFT: 3

PANEL: (BACK OF BLISTER

PACK)

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PAGE: 12 of 13

DRAFT: 3

STARTGARD FOR PUPPIES

(FRONTLINE TOP SPOT SMALL DOG)

FRONT OF PIPETTE

30

SEPTEM

BER

1998

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS

FOR ANIMAL TREATMENT ONLY

FRONTLINE@

TOP SPOT SMALL DOG

FlPRONlL

READ ACCOMPANYING INSTRUCTIONS

BEFORE USE

0.67 mL

AR6

7542

(MERIAL

LOGO)

G:UIEGAFmLABELSVlEARTG-l\STARTPUl.DOC

“CAUTION” to be bold & at

least half the height of

“FRONTLINE*.

Next 3 lines

to be bold and at least four

-tenths the height of

“CAUTION”

JO/Q9

'98 WED

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@lo17

STARTGARD

FOR

PUPPIES

(FRONTLINE TOP SPOT SMALL DOG)

PAGE: 13 of 13

30

SEPTEMBER

1998

DRAFT: 3

BACK OF PIPETTE

(Stamped with Batch and

Expity

date)

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