FASINEX 120 FLUKICIDE FOR CATTLE AND SHEEP

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

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Active ingredient:
TRICLABENDAZOLE
Available from:
Elanco Australasia Pty Ltd
INN (International Name):
triclabendazole(120g/L)
Pharmaceutical form:
ORAL SOLUTION/SUSPENSION
Composition:
TRICLABENDAZOLE TRIAZOLE Active 120.0 g/L
Units in package:
1L; 5L
Class:
VM - Veterinary Medicine
Manufactured by:
ELANCO AUSTRALASIA
Therapeutic group:
CATTLE | SHEEP | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | EWE | HEIFER | H
Therapeutic area:
PARASITICIDES
Therapeutic indications:
LIVER FLUKE
Product summary:
Poison schedule: 0; Withholding period: WHP: MEAT - DO NOT USE LESS THAN 28 DAY S BEFORE SLAUGHTER FOR HUMAN CONSUMPTIO N. MILK - NOT TO BE USED FOR ANIMALS P RODUCING MILK FOR HUMAN CONSUMPTION OR PROCESSING. DO NOT USE LESS THAN 7 DAYS BEFORE CALVING LAMBING OR KIDDING IN COWS, EWES OR DOES WHERE MILK AND MILK PRODUCTS FROM TREATED ANIMALS MAY BE U SED FOR HUMAN CONSUMPTION. WHERE FASINE X 120 IS ACCIDENTALLY GIVEN WITHIN THIS PERIOD OR SHOULD ANY COWS, EWES OR DOE S CALVE LAMB OR KID EARLIER THAN 7 DAY S AFTER TREATMENT MILK WILL CONTAIN RE SIDUES. THIS MILK MUST NOT BE USED FOR HUMAN CONSUMPTION OR SUPPLIED FOR PROC ESSING FOR AT LEAST 14 DAYS FOLLOWING T REATMENT. CALVES FED THIS MILK WITHIN 1 0 DAYS OF SLAUGHTER MUST NOT BE USED FO R HUMAN CONSUMPTION. KIDS OR LAMBS FED THIS MILK WITHIN 7 DAYS OF SLAUGHTER MU ST NOT BE USED FOR HUMAN CONSUMPTION.; Host/pest details: CATTLE: [LIVER FLUKE]; SHEEP: [LIVER FLUKE]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [LIVER FLUKE]; SHEEP: [LIVER FLUKE]; For the treatment of susceptible early immature, immature and mature liver fluke in cattle and sheep.
Authorization status:
Registered
Authorization number:
47675
Authorization date:
2020-07-01

Product name

: Fasinex 120 Flukicide for Cattle and Sheep

Date

: 25th November, 1998

Page

: 1 of 6

Pack sizes

: 1 L and 5 L

Type of label

: Bottle and Leaflet

File

: Fasinex120label.doc

Version

: 3

Reason

: Update with changes for new pack design (MC)

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 6/4/95 ________

Bottle, front panel

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

Fasinex 120 Flukicide for Cattle and Sheep

For the treatment of susceptible Early Immature, Immature and Mature liver fluke (

Fasciola hepatica

) in cattle

and sheep.

Active Constituent: 120 g/L TRICLABENDAZOLE

1 L / 5 L

Product name

: Fasinex 120 Flukicide for Cattle and Sheep

Date

: 25th November, 1998

Page

: 2 of 6

Pack sizes

: 1 L and 5 L

Type of label

: Bottle and Leaflet

File

: Fasinex120label.doc

Version

: 3

Reason

: Update with changes for new pack design (MC)

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

Bottle, Back panel

FASINEX 120

Flukicide for Cattle and Sheep

READ INSTRUCTION LEAFLET BEFORE USING THIS PRODUCT.

DIRECTIONS FOR USE

SHAKE WELL BEFORE USE

ORAL DOSE RATE:

SHEEP 1 mL per 12 kg BW

CATTLE 5 mL per 50 kg BW

Precaution:

In areas where Black Disease is known to occur, adequate vaccination procedures are advised.

WITHHOLDING PERIODS

MEAT - 28 DAYS

MILK - NOT TO BE USED FOR ANIMALS PRODUCING MILK FOR HUMAN CONSUMPTION OR

PROCESSING.

See leaflet for full withholding period instructions.

Protection of Livestock, Wildlife and Others

Dangerous to fish. DO NOT contaminate dams, rivers or streams with the drench or used container.

SAFETY DIRECTIONS

Harmful if absorbed by skin contact or swallowed. Avoid contact with skin. Wash hands after use.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (Ph: 13 1126).

Material Safety Data Sheet:

If additional hazard information is required refer to the Material Safety Data

Sheet. For a copy phone (1800) 633 768.

Storage:

Store below 30

C (Room Temperature) in original container, tightly closed, in a cool dry place.

Keep out of reach of children.

Disposal:

Triple rinse containers before disposal and dispose of rinsate in a disposal pit away from desirable

plants and their roots, and watercourses. On-site disposal of undiluted chemicals is unacceptable.

Destroy empty containers by breaking, crushing, puncturing or shredding them where applicable. Dispose of the

containers at a local authority landfill that does not burn its refuse. If there is no local authority landfill readily

available in your area, bury the containers at a depth of 500 mm or more at a licensed/approved disposal site. In

some States wastes can only be buried at a licensed landfill. DO NOT burn empty containers or product.

Product name

: Fasinex 120 Flukicide for Cattle and Sheep

Date

: 25th November, 1998

Page

: 3 of 6

Pack sizes

: 1 L and 5 L

Type of label

: Bottle and Leaflet

File

: Fasinex120label.doc

Version

: 3

Reason

: Update with changes for new pack design (MC)

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

Parasite

Controlled

Bodyweight

(BW) kg

Oral Dose

(mL)

Doses per pack

Liver Fluke

Cattle

1 L

5 L

(Fasciola

up to 100

hepatica)

101-150

Early

151-200

Immature,

201-250

Immature

251-300

And Mature

301-400

401-500

501-600

601-650

Over 650

5 mL/50 kg liveweight

Liver Fluke

Sheep

(Fasciola

up to 12

1000

5000

hepatica)

13-24

2500

Early

25-36

1666

Immature,

37-48

1250

Immature

49-60

1000

and Mature

61-72

Over 72

1 mL/12 kg liveweight

MANUFACTURER’S WARRANTY AND EXCLUSION OF LIABILITY

This product is warranted fit for the purposes specifically recommended by Novartis Animal Health

Australasia Pty Ltd when used strictly as directed on this label. All other warranties and obligations or

liabilities, whether expressed or implied by statute or otherwise, are excluded to the full extent that

exclusion is permitted by law.

NRA Approval No. 47675/01A

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

Batch Number

Expiry Date

Product name

: Fasinex 120 Flukicide for Cattle and Sheep

Date

: 25th November, 1998

Page

: 4 of 6

Pack sizes

: 1 L and 5 L

Type of label

: Bottle and Leaflet

File

: Fasinex120label.doc

Version

: 3

Reason

: Update with changes for new pack design (MC)

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

Leaflet

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

Fasinex 120

Flukicide for Cattle and Sheep

Active Constituent: 120 g/L TRICLABENDAZOLE

Complete directions for use inside

- Read before using

For the treatment of susceptible Early Immature, Immature and Mature liver fluke (Fasciola hepatica) in

cattle and sheep.

General Instructions:

SHAKE WELL BEFORE USE

Precaution: In areas where Black Disease is known to occur, adequate vaccination procedures are advised.

Fasinex 120 is a ready to use, free flowing aqueous suspension for the treatment and control of acute and

chronic fasciolosis of cattle and sheep.

Fasinex 120 contains triclabendazole, a member of the

Benzimidazole

family of drenches. It is effective against

sensitive strains of

Fasciola hepatica

(liver fluke).

Resistance may develop to any drench.

Fasinex 120 when used at the recommended rate of 12 mg triclabendazole/kg bodyweight for cattle, i.e. 5 mL

Fasinex 120 per 50 kg bodyweight, and 10 mg/kg for sheep, i.e. 1 mL Fasinex 120 per 12 kg bodyweight, is

highly effective against susceptible early immature fluke as well as immature and adult fluke, and has a high

safety margin.

Ask your local veterinary practitioner or animal health adviser for recommended parasite management practices

for your area to reduce development of resistance. It is advisable that a drench resistance test be conducted

before any drench is used.

WITHHOLDING PERIODS

MEAT - DO NOT USE LESS THAN 28 DAYS BEFORE SLAUGHTER FOR HUMAN

CONSUMPTION.

Note: The withholding period for meat applies only to meat destined for the Australian domestic market.

Some export markets apply different standards which may require an export slaughter interval. If meat

from the animal on which this product is to be used may be sold outside the Australian domestic market,

details of overseas standards should be obtained prior to use of this product.

Product name

: Fasinex 120 Flukicide for Cattle and Sheep

Date

: 25th November, 1998

Page

: 5 of 6

Pack sizes

: 1 L and 5 L

Type of label

: Bottle and Leaflet

File

: Fasinex120label.doc

Version

: 3

Reason

: Update with changes for new pack design (MC)

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

MILK - NOT TO BE USED FOR ANIMALS PRODUCING MILK FOR HUMAN CONSUMPTION OR

PROCESSING.

DO NOT USE LESS THAN 7 DAYS BEFORE CALVING, LAMBING OR KIDDING IN COWS, EWES

OR DOES WHERE MILK AND MILK PRODUCTS FROM TREATED ANIMALS MAY BE USED

FOR HUMAN CONSUMPTION. Where Fasinex 120 is accidentally given within this period or should

any cows or ewes ,calve or lamb earlier than 7 days after treatment, milk will contain residues. This milk

must not be used for human consumption, or supplied for processing for at least 14 days following

treatment. Calves fed this milk within 10 days of slaughter must not be used for human consumption.

Kids or lambs fed this milk within 7 days of slaughter must not be used for human consumption.

SAFETY DIRECTIONS

Harmful if absorbed by skin contact or swallowed. Avoid contact with skin. Wash hands after use.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (Ph: 13 1126).

Storage:

Store below 30

C (Room Temperature) in original container, tightly closed, in a cool dry place.

Keep out of reach of children.

Disposal:

Triple rinse containers before disposal and dispose of rinsate in a disposal pit away from desirable

plants and their roots, and watercourses. On-site disposal of undiluted chemicals is unacceptable.

Destroy empty containers by breaking, crushing, puncturing or shredding them where applicable. Dispose of

the containers at a local authority landfill that does not burn its refuse. If there is no local authority landfill

readily available in your area, bury the containers at a depth of 500mm or more at a licensed/approved disposal

site. In some States wastes can only be buried at a licensed landfill. DO NOT burn empty containers or

product.

Protection of Livestock, Wildlife and Others

Dangerous to fish. DO NOT contaminate dams, rivers or streams with the drench or used container.

Material Safety Data Sheet:

If additional hazard information is required refer to the Material Safety Data

Sheet. For a copy phone 1800 633 768.

MANUFACTURER’S WARRANTY AND EXCLUSION OF LIABILITY

This product is warranted fit for the purposes specifically recommended by Novartis Animal Health

Australasia Pty Limited when used strictly as directed in this leaflet. All other warranties and

obligations for liabilities, whether expressed or implied by statute or otherwise, are excluded to the full

extent that exclusion is permitted by law.

NRA 47675/01A

®

Registered trademark of Novartis Inc., Basle, Switzerland.

Novartis Animal Health Australasia Pty Limited, ACN 076 745 198,

140-150 Bungaree Road, Pendle Hill NSW 2145

Product name

: Fasinex 120 Flukicide for Cattle and Sheep

Date

: 25th November, 1998

Page

: 6 of 6

Pack sizes

: 1 L and 5 L

Type of label

: Bottle and Leaflet

File

: Fasinex120label.doc

Version

: 3

Reason

: Update with changes for new pack design (MC)

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

Directions for Use

Restraints: NOT TO BE USED FOR ANIMALS PRODUCING MILK FOR HUMAN CONSUMPTION

OR PROCESSING.

Parasite

Controlled

Bodyweight

(BW) kg

Oral Dose

(mL)

No. treated

per litre

Critical Comments

Liver Fluke

Cattle

1. FASINEX may be administered at the same

(Fasciola

up to 100

time as animals are treated for lice.

hepatica)

101-150

2. FASINEX may be administered to calves,

Early

151-200

pregnant cows or weak or debilitated animals.

Immature,

201-250

3. Wash out equipment with water after use.

Immature

251-300

4. FASINEX is palatable to cattle.

And Mature

301-400

5. Cattle in excess of 650 kg should be dosed

401-500

at 5 mL per 50 kg liveweight. Dose rate to be based

501-600

on heaviest cattle in the mob. Animals should be

601-650

weighed either with scales or a

Over 650

5 mL/50 kg liveweight

weighband.

Liver Fluke

Sheep

1. FASINEX may be administered to lambs,

(Fasciola

up to 12

1000

pregnant or lactating ewes or weak or

hepatica)

13-24

debilitated animals.

Early

25-36

2. Vaccination against Black Disease should be

Immature,

37-48

maintained.

Immature

49-60

3. FASINEX does not stain wool

and Mature

61-72

4. Wash out equipment with water after use.

Over 72

1 mL/12 kg liveweight

5. FASINEX can be used at the same time as jetting with

Vetrazin® or dipping with Topclip® dips, or most

pour-on lousicides.

6. FASINEX is palatable to sheep .

7. Sheep in excess of 72 kg to be dosed at a rate of 1 mL

per 12 kg of bodyweight. Sheep should

be weighed. Dose the mob according to the

heaviest animal in each group.

DO NOT underdose.

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