FASIMEC CATTLE ORAL FLUKICIDE AND BROAD SPECTRUM DRENCH

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Patient Information leaflet (PIL)

14-02-2006

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

IVERMECTIN; TRICLABENDAZOLE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

triclabendazole(120g/L)+ivermectin(2g/L)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

IVERMECTIN ANTHELMINTIC Active 2.0 g/L; TRICLABENDAZOLE TRIAZOLE Active 120.0 g/L

Units in package:

15L; 1L; 2.5L; 20L; 5L; 5L Gunpack

Class:

VP - Veterinary Pesticide

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 5; Withholding period: WITHHOLDING PERIODS MEAT: DO NOT USE le ss than 21 days before slaughter for hum an consumption. MILK: DO NOT USE in lac tating cows or within 28 days of calving where milk may be used or processed for human consumption. TRADE ADVICE–EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE le ss than 56 days before slaughter for exp ort. Before using this product, confirm the current ESI from the Elanco Australa sia Pty Ltd on 1800 226 324 or the APVMA website (www.apvma.gov.au/residues).; Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LIVER FLUKE - MATURE AND IMMATURE, LUNGWORM - DICTYOCAULUS VIVIPARUS, NODULE WORM - OESOPHAGOSTOMUM RADIATUM, SHORTNOSED CATTLE LOUSE, SMALL BROWN STOMACH WORM - O. OSTERTAGI, SMALL INTESTINAL WORM , STOMACH HAIR WORM, SUCKING LICE - LINOGNATHUS VITULI, THIN NECKED INTESTINAL WORM, TUBERCLE-BEARING LOUSE, WHIPWORM - TRICHURIS OVIS (ADULTS ONLY)]; Poison schedule: 5; Withholding period: WHP: Meat:Do not use less than 21 days before slaughter for human consumption . Milk:Do not use in lactating cows or within 28 days of calving where milk or milk products may be used for human c onsumption. TRADE ADVICE EXPORT SLAUGH TER INTERVAL (ESI): Do not use less tha n 56 days before slaughter for export. The ESI on this label was correct at th e time of label approval. Before using this product confirm the current ESI f rom the manufacturer on 1800 633 768 or the APVMA website (www.apvma.gov.au/re sidues/ESI.shtml); Host/pest details: CATTLE: [BARBER'S POLE WORM - HAEMONCHUS PLACEI, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LIVER FLUKE - MATURE AND IMMATURE, LUNGWORM - DICTYOCAULUS VIVIPARUS, NODULE WORM - OESOPHAGOSTOMUM RADIATUM, SHORTNOSED CATTLE LOUSE, SMALL BROWN STOMACH WORM - O. OSTERTAGI, SMALL INTESTINAL WORM , STOMACH HAIR WORM, SUCKING LICE - LINOGNATHUS VITULI, THIN NECKED INTESTINAL WORM, TUBERCLE-BEARING LOUSE, WHIPWORM - TRICHURIS OVIS (ADULTS ONLY)]; For the treatment of triclabendazole-sensitive early immature, immature and mature liver fluke in cattle. For the treatment and control of ivermectin sensitive strains of roundworms and lungworm, and sucking lice in cattle.NOT TO BE USED for animals producing milk for human consumption or processing

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

315MM WIDE
94MM DEEP
160126
04 Fasimec Cattle 1L T+B
Novartis
24/03/2009
95MM WIDE
95MM DEEP
READ INSTRUCTION LEAFLET BEFORE USING THIS
PRODUCT
DIRECTIONS FOR USE
RESTRAINTS: NOT TO BE USED FOR ANIMALS
PRODUCING MILK FOR HUMAN CONSUMPTION OR
PROCESSING.
SHAKE WELL BEFORE USE
ORAL DOSE RATE: CATTLE 5 ML PER 50 KG BW
WITHHOLDING PERIODS
MEAT - DO NOT USE LESS THAN 21 DAYS BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
MILK -
DO NOT USE IN LACTATING COWS OR WITHIN 28 DAYS OF CALVING WHERE
MILK OR MILK PRODUCTS MAY BE USED FOR HUMAN CONSUMPTION.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE LESS THAN 56 DAYS
BEFORE SLAUGHTER FOR EXPORT. THE ESI ON THIS LABEL WAS CORRECT AT THE
TIME OF
LABEL APPROVAL. BEFORE USING THIS PRODUCT, CONFIRM THE CURRENT ESI
FROM THE
MANUFACTURER ON 1800 633 768 OR THE APVMA WEBSITE
(WWW.APVMA.GOV.AU/RESIDUES/ESI.SHTML).
PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND THE ENVIRONMENT: Ivermectin is
extremely toxic to aquatic
species. DO NOT contaminate dams, rivers, streams or other
waterways with the chemical or used containers.
SAFETY DIRECTIONS: MAY IRRITATE THE EYES. AVOID CONTACT WITH EYES.
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.
DISPOSAL: This container can be recycled if it is clean, dry,
free of visible residues and
has the _DRUMMUSTER_ logo visible.
Triple or pressure rinse container for disposal.
Dispose of rinsate or any undiluted chemical according to State
legislative requirements.
Wash outside of the container and the cap. Store cleaned container in
a sheltered place
with cap removed. It will then be acceptable for recycling at any
_DRUMMUSTER_
collection or similar container management program site. The cap
should not be replaced
but may be taken separately.
STORAGE: Store below 30˚C (Room Temperature) in original container,
tightly closed, in a
cool, dry pl

Read the complete document

Summary of Product characteristics

PRODUCT NAME: FASIMEC® CATTLE ORAL FLUKICIDE
AND BROAD SPECTRUM DRENCH
PAGE: 1 OF 6
THIS REVISION ISSUED: JULY, 2013

SAFETY DATA SHEET
Issued by: Novartis Animal Health Australasia Pty Ltd.
Phone: 02 9805 3555 (office hours)
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 02 9805 3555
(OFFICE HOURS)
54 WATERLOO RD
FAX 02 9888 8387
NORTH RYDE, NSW 2113

CHEMICAL NATURE:
Triclabendazole (a benzimidazole) and Ivermectin (a macrocyclic
lactone) in a
suitable aqueous medium.
TRADE NAME:
FASIMEC
®
CATTLE ORAL FLUKICIDE AND BROAD SPECTRUM DRENCH

APVMA CODE:
52406
PRODUCT USE:
Veterinary drench for use as described on the product label.
CREATION DATE:
JULY, 2013
THIS VERSION ISSUED:
JULY, 2013 and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xn, Harmful. N, Dangerous to the environment. Hazardous according to
the criteria
of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods
(ADG) Code.
RISK PHRASES:

R22, R51, R48/22. Harmful if swallowed. Toxic to aquatic organisms.
Harmful:
danger of serious damage to health by prolonged exposure if
swallowed.
SAFETY PHRASES:

S20, S36, S61, S24/25. When using, do not eat or drink.
Wear suitable protective
clothing. Avoid release to the environment. Refer to special
instructions/Safety Data
Sheets. Avoid contact with skin and eyes.
SUSMP CLASSIFICATION:

S5
ADG CLASSIFICATION:

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

GHS SIGNAL WORD: WARNING
HAZARD STATEMENT:
H302: Harmful if swallowed.
H373: May cause damage to organs through prolonged or
repeated exposure.
H401: Toxic to aquatic life.
PR

Read the complete document