FASINEX 240 ORAL FLUKICIDE FOR CATTLE AND SHEEP

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TRICLABENDAZOLE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

triclabendazole(240g/L)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

TRICLABENDAZOLE TRIAZOLE Active 240.0 g/L

Units in package:

13L; 2.2L; 5L

Class:

VP - Veterinary Pesticide

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER

Therapeutic area:

PARASITICIDES

Therapeutic indications:

LIVER FLUKE

Product summary:

Poison schedule: 6; Withholding period: MEAT: DO NOT USE less than 21 days befor e slaughter for human consumption MILK: DO NOT USE in lactating animals where m ilk or milk products may be used or proc essed for human consumption. DO NOT USE less than 21 days before calving or lam bing in cows or ewes where milk and milk products from treated animals may be us ed for human consumption. Where FASINEX 240 is accidentally given within this p eriod or should any cows or ewes calve o r lamb earlier than 21 days after treatm ent, milk will contain residues. This mi lk must not be used for human consumpti on, or supplied for processing for at le ast 21 days following treatment. Calves fed this milk should not be slaughtered for human consumption within 10 days. La mbs fed this milk should not be slaughte red for human consumption within 7 days. (CATTLE) DO NOT USE less than 56 days before slaughter for export. (SHEEP) DO NOT USE less than 63 days before slaugh ter for export. The ESI on this label w as correct at the time of label approval . Before using this product, confirm the current ESI from Elanco Australasia Pty Ltd on 1800 226 324 or the APVMA websit e (www.apvma.gov.au/residues).; Host/pest details: CATTLE: [LIVER FLUKE]; SHEEP: [LIVER FLUKE]; For the treatment of triclabendazole-susceptible early immature, immature and mature liver fluke in cattle.DO NOT USE in lactating cows where milk or milk products may be used for human consumption.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

FASINEX 240 ORAL FLUKICIDE FOR CATTLE AND SHEEP
51262/118513
Product Name:
APVMA Approval No:
Label Name:
FASINEX 240 ORAL FLUKICIDE FOR CATTLE AND SHEEP
Signal Headings:
POISON
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
240 g/L TRICLABENDAZOLE
Claims:
FASINEX 240 contains triclabendazole, a member of the benzimidazole
family of drenches.
It is effective against triclabendazole sensitive strains of Fasciola
hepatica (liver fluke).
For the treatment of triclabendazole-susceptible Early Immature,
Immature and Mature liver
fluke (Fasciola hepatica) in cattle and sheep.
Resistance may develop to any drench.
Ask your local veterinary practitioner or animal health advisor 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.
Net Contents:
2.2 Litres, 5 Litres, 13 Litres
Directions for Use:
Restraints:
DO NOT USE in lactating cows or ewes where milk may be used or
processed for human
consumption.
Contraindications:
Precautions:
Side Effects: RLP APPROVED
Dosage and
Administration:
SHAKE WELL BEFORE USE
ORAL DOSE RATE: CATTLE 2.5mL per 50kg BW, SHEEP 0.5mL per 10kg BW.
See attached dose tables for Cattle and Sheep.
CATTLE CRITICAL COMMENTS:
1. FASINEX 240 may be administered at the same time as animals are
treated for lice.
2. FASINEX 240 may be administered to calves, pregnant cows, or weak
or debilitated
animals.
3. Wash out equipment with water after use.
4. FASINEX 240 is palatable to cattle.
5. Cattle in excess of 650kg are to be dosed at a rate of 2.5mL per
50kg bodyweight. A
representative sample of animals should be weighed before treatment
either with scales or
a weighband. Dose rate to be based on heaviest cattle in each group
(bulls, cows, steers,
calves).
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.
SHEEP CRITICA

Summary of Product characteristics

 
PRODUCT NAME: FASINEX® 240 ORAL FLUKICIDE FOR CATTLE 
PAGE: 1 OF 5 
THIS REVISION ISSUED: DECEMBER, 2012 

SAFETY DATA SHEET 
Issued by: Novartis Animal Health Australasia Pty Ltd. 
Phone: [phone] 
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA,
(0800 764 766 IN NEW ZEALAND)

SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER 
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LTD.      
ABN 64 076 745 198

TELEPHONE [phone] 
54 WATERLOO RD 
FAX [phone] 
NORTH RYDE, NSW  2113 

CHEMICAL NATURE:  
Triclabendazole is a benzimidazole derivative.

TRADE NAME:  
FASINEX
®
 240 ORAL FLUKICIDE FOR CATTLE 
PRODUCT CODE: 

51262 
PRODUCT USE:  
Veterinary drench for use as described on the product label. 

CREATION DATE: 
NOVEMBER, 2012 
THIS VERSION ISSUED: 
DECEMBER, 2012
 and is valid for 5 years from this date.

SECTION 2 - HAZARDS IDENTIFICATION 
STATEMENT OF HAZARDOUS NATURE 
This product is classified as: 
Xn, Harmful. Hazardous according to the criteria of SWA.  
Not a Dangerous Good according
to the Australian Dangerous Goods (ADG) Code. 
RISK PHRASES: 
R48/25, R51. Toxic: danger of serious damage to health
by prolonged exposure if 
swallowed. Toxic to aquatic organisms.  
SAFETY PHRASES:

S23, S25, S61. Do not breathe vapours or mists.
Avoid contact with eyes. Avoid 
release to the environment. Refer to
special instructions/Safety Data Sheets.  
SUSMP CLASSIFICATION:

S6 
ADG CLASSIFICATION:

None allocated. Not a Dangerous Good under the ADG Code. 
UN NUMBER: 
None allocated. 

GHS SIGNAL WORD: WARNING  
HAZARD STATEMENT: 
H373: May cause damage to organs through prolonged or repeated
exposure. 
H401 Toxic to aquatic life. 
PREVENTION 
P260: Do not breathe fumes, mists, vapours or spray. 
P281: Use personal protective equipment as required