FASINEX 50 FLUKICIDE FOR SHEEP CATTLE AND GOATS

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(50g/L)
Pharmaceutical form:
ORAL SOLUTION/SUSPENSION
Composition:
TRICLABENDAZOLE TRIAZOLE Active 50.0 g/L
Units in package:
20L; 5L
Class:
VM - Veterinary Medicine
Manufactured by:
ELANCO AUSTRALASIA
Therapeutic group:
CATTLE | GOAT | SHEEP | BEEF | BILLY | BOS INDICUS | BOS TAURUS | BOVINE | BUCK | BUFFALO | BULL | BULLOCK | CALF | CAPRA HIRCUS
Therapeutic area:
PARASITICIDES
Therapeutic indications:
LIVER FLUKE
Product summary:
Poison schedule: 0; Withholding period: WHP:Meat:Do not use less than 28 days before slaughter for human consumption. Milk:Not to be used for animals produc ing milk for human consumption or proce ssing. Do not use less than 7 days b efore calving lambing or kidding in c ows ewes or does where milk and milk p roducts from treated animals may be use d for human consumption.; Host/pest details: CATTLE: [LIVER FLUKE]; GOAT: [LIVER FLUKE]; SHEEP: [LIVER FLUKE]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [LIVER FLUKE]; GOAT: [LIVER FLUKE]; SHEEP: [LIVER FLUKE]; For the treatment of susceptible early immature, immature and mature liver fluke in sheep, cattle and goats.Restraints: NOT TO BE USED FOR ANIMALS PRODUCING MILK FOR HUMAN CONSUMPTION OR PROCESSING. Other Warnings, etc: SEE LABEL.
Authorization status:
Registered
Authorization number:
47676
Authorization date:
2020-07-01

Product name:

Fasinex 50 Flukicide for Sheep, Cattle and Goats

Page:

1 of 6

Date: 15 December 1998

Type of Label:

Bottle and leaflet

File:

Fasinex50label.doc

Version:

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

®

50

Flukicide for Sheep, Cattle and Goats

Active Constituent: 50 g/L TRICLABENDAZOLE

5 L / 20 L

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

in sheep, cattle and goats.

SHAKE WELL BEFORE USE

Product name:

Fasinex 50 Flukicide for Sheep, Cattle and Goats

Page:

2 of 6

Date: 15 December 1998

Type of Label:

Bottle and leaflet

File:

Fasinex50label.doc

Version:

Reason:

Update with changes for new pack design (MC)

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

Bottle - back panel

FASINEX 50

Flukicide for Sheep, Cattle and Goats

READ INSTRUCTION LEAFLET BEFORE USING THIS PRODUCT.

DIRECTIONS FOR USE

SHAKE WELL BEFORE USE

ORAL DOSE RATE:

Sheep and Goats 1 mL per 5 kg BW

Cattle 12 mL per 50 kg BW

WITHHOLDING PERIODS

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

CONSUMPTION.

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.

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 50 Flukicide for Sheep, Cattle and Goats

Page:

3 of 6

Date: 15 December 1998

Type of Label:

Bottle and leaflet

File:

Fasinex50label.doc

Version:

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

5 L 20 L

Liver Fluke

Sheep & Goats

(Fasciola

up to 10

2500

10000

hepatica)

10-20

1250

5000

Early

21-30

3333

Immature,

31-40

2500

Immature

41-50

2000

and Mature

51-60

1666

61-70

1428

71-75

1333

Over 75

1 mL/5 kg liveweight

Liver Fluke

Cattle

(Fasciola

up to 100

hepatica)

101-150

Early

151-200

Immature,

201-250

Immature

251-300

and Mature

301-350

351-400

401-450

451-500

501-550

551-600

601-650

Over 650

12 mL/50 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. 47676/01A

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 50 Flukicide for Sheep, Cattle and Goats

Page:

4 of 6

Date: 15 December 1998

Type of Label:

Bottle and leaflet

File:

Fasinex50label.doc

Version:

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

®

50

Flukicide for Sheep, Cattle and Goats

Active Constituent: 50 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 sheep, cattle and goats.

General Instructions:

SHAKE WELL BEFORE USE

Precaution:

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

Fasinex 50 is a ready to use, free flowing aqueous suspension for the treatment and control of acute and chronic

fasciolosis of sheep, cattle and goats.

Fasinex 50 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 50 when used at the recommended rate of 10 mg triclabendazole/kg bodyweight for sheep and goats i.e.

1 mL Fasinex 50 per 5 kg bodyweight and 12 mg/kg for cattle i.e. 12 mL Fasinex 50 per 50 kg bodyweight,

combines high efficacy against all ages of susceptible fluke with 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.

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 50 is accidentally given within this period or

should any cows, ewes or does calve, lamb or kid 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.

Product name:

Fasinex 50 Flukicide for Sheep, Cattle and Goats

Page:

5 of 6

Date: 15 December 1998

Type of Label:

Bottle and leaflet

File:

Fasinex50label.doc

Version:

Reason:

Update with changes for new pack design (MC)

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

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.

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 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.

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 47676/01A

®

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 50 Flukicide for Sheep, Cattle and Goats

Page:

6 of 6

Date: 15 December 1998

Type of Label:

Bottle and leaflet

File:

Fasinex50label.doc

Version:

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

Sheep & Goats

(Fasciola

up to 10

1. FASINEX may be administered to lambs,

hepatica)

10-20

pregnant or lactating ewes or weak or

Early

21-30

debilitated animals.

Immature,

31-40

2. Vaccination against Black Disease should be

Immature

41-50

maintained.

and Mature

51-60

3. FASINEX does not stain wool

61-70

4. Wash out equipment with water after use.

71-75

5. FASINEX can be used at the same time as

Over 75

1 mL/5 kg liveweight

jetting with Vetrazin® or dipping with Topclip® dips, or

most pour-on lousicides.

6. FASINEX is palatable to sheep and goats.

7. Animals in excess of 75 kg to be dosed at a rate of 1

mL per 5 kg . A representative sample of animals should

be weighed before treatment. Dose the mob to the

heaviest animal (by liveweight) in each group (ewes,

rams, lambs); (bucks, does, kids). DO NOT underdose.

Where there is a large variation in size within the group,

dose rate should be based on the label directions for each

weight range. Drafting into two or more lines may be

appropriate, to avoid excessive overdosing.

Liver Fluke

Cattle

(Fasciola

up to 100

1. FASINEX may be administered at the same

hepatica)

101-150

time as animals are treated for lice.

Early

151-200

2. FASINEX may be administered to calves,

Immature,

201-250

pregnant cows or weak or debilitated animals.

Immature

251-300

3. Wash out equipment with water after use.

and Mature

301-350

4. FASINEX is palatable to cows. .

351-400

5. Cattle in excess of 650 kg should be dosed at

401-450

the rate of 12 mL per 50 kg . . A

451-500

representative sample of animals should be weighed

501-550

before treatment with either scales or a weighband.

551-600

601-650

Over 650

12 mL/50 kg liveweight

Dose rate to be based on heaviest cattle in each group

(bulls, cows, steers, calves, etc). DO NOT underdose.

Where there is a large variation in size within the group,

draft into two or more lines based on bodyweight, to

avoid excessive overdosing.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER CONTRARY TO THIS LABEL,

UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

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