CYDECTIN PLUS FLUKE ORAL SOLUTION FOR SHEEP

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

MOXIDECTIN; TRICLABENDAZOLE

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

moxidectin(1mg/mL)+triclabendazole(50mg/mL)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

MOXIDECTIN ANTHELMINTIC Active 1.0 mg/ml; TRICLABENDAZOLE TRIAZOLE Active 50.0 mg/ml

Units in package:

10L; 15L; 5L

Class:

VP - Veterinary Pesticide

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 5; Withholding period: MEAT: DO NOT USE less than 21 days befor e slaughter for human consumption. MILK : DO NOT USE in female sheep which are p roducing or may in the future produce mi lk or milk products for human consumptio n. EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE less than 70 days before slaught er for export.; Host/pest details: SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., COOPERIA CURTICEI, COOPERIA ONCOPHORA, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, LIVER FLUKE, NEMATODIRUS ABNORMALIS, NEMATODIRUS BATTUS, NEMATODIRUS FILICOLLIS, NEMATODIRUS HELVETIANUS, NODULE WORM - , OSTERTAGIA CIRCUMCINCTA, OSTERTAGIA TRIFURCATA, SHEEP ITCH MITE, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , STOMACH HAIR WORM, THIN NECKED INTESTINAL WORM, THIN NECKED INTESTINAL WORM N. SPATHIGER, TRICHOSTRONGYLUS RUGATUS, WHIPWORM - TRICHURIS OVIS]; Poison schedule: 5; Withholding period: WHP: MEAT: DO NOT USE less than 21 day s before slaughter for human consumpti on. MILK: DO NOT USE in female sheep wh ich are producing or may in the future produce milk or milk products for huma n consumption. EXPORT SLAUGHTER INTERVA L (ESI): DO NOT USE less than 70 days b efore slaughter for export.; Host/pest details: SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., COOPERIA CURTICEI, COOPERIA ONCOPHORA, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, LIVER FLUKE, NEMATODIRUS ABNORMALIS, NEMATODIRUS BATTUS, NEMATODIRUS FILICOLLIS, NEMATODIRUS HELVETIANUS, NODULE WORM - , OSTERTAGIA CIRCUMCINCTA, OSTERTAGIA TRIFURCATA, SHEEP ITCH MITE, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , STOMACH HAIR WORM, THIN NECKED INTESTINAL WORM, THIN NECKED INTESTINAL WORM N. SPATHIGER, TRICHOSTRONGYLUS RUGATUS, WHIPWORM - TRICHURIS OVIS]; Poison schedule: 5; Withholding period: ; Host/pest details: SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., COOPERIA CURTICEI, COOPERIA ONCOPHORA, INTESTINAL HAIR WORM - T. COLUBRIFORMIS, INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, LIVER FLUKE, NEMATODIRUS ABNORMALIS, NEMATODIRUS BATTUS, NEMATODIRUS FILICOLLIS, NEMATODIRUS HELVETIANUS, NODULE WORM - , OSTERTAGIA CIRCUMCINCTA, OSTERTAGIA TRIFURCATA, SHEEP ITCH MITE, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , STOMACH HAIR WORM, THIN NECKED INTESTINAL WORM, THIN NECKED INTESTINAL WORM N. SPATHIGER, TRICHOSTRONGYLUS RUGATUS, WHIPWORM - TRICHURIS OVIS]; For the treatment and control of moxidectin sensitive gastrointestinal parasites (including benzimidazole and/or levamisole resistant strains), lungworm, itchmite and triclabendazole sensitive strains of liver fluke of sheep.DO NOT USE in female sheep which are producing or may in the future produce milk or milk products for human consumption. NOT recommended for use in goats as safety/efficacy has not been evaluated.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

VIRBAC (AUSTRALIA) PTY LIMITED
Page 1 of 8
PRODUCT NAME:
Cydectin Plus Fluke Oral Solution for Sheep
APVMA NO:
63506
VERSION DATE:
29 Aug 2011
PACK SIZES:
5 L, 10 L, 15 L
Text above this line or in italics between parallel lines is not
included in the label copy.
PRIMARY LABEL - Front Panel
CAUTION
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
CYDECTIN
®
PLUS FLUKE
ORAL SOLUTION FOR SHEEP
ACTIVE CONSTITUENTS:
1 MG/ML MOXIDECTIN
50 MG/ML TRICLABENDAZOLE
FOR THE TREATMENT AND CONTROL OF MOXIDECTIN SENSITIVE GASTROINTESTINAL
PARASITES
(INCLUDING
BENZIMIDAZOLE
AND/OR
LEVAMISOLE RESISTANT STRAINS), LUNGWORM, ITCHMITE AND
TRICLABENDAZOLE SENSITIVE STRAINS OF LIVER FLUKE (
FASCIOLA HEPATICA) OF SHEEP.
CONTENTS
5 LITRES [10, 15 LITRES]
® Registered trademark of Virbac (Australia) Pty Ltd
PRIMARY LABEL - Back Panel
CYDECTIN
®
PLUS FLUKE ORAL SOLUTION FOR SHEEP contains moxidectin, a second
generation macrocyclic lactone endectocide that is effective against
parasites sensitive to this
family and triclabendazole, which is effective against liver fluke.
The following parasites can be
treated with this product;
LIVER FLUKE (EARLY IMMATURE, IMMATURE AND ADULT)
:
Fasciola hepatica
MATURE (ADULT) AND IMMATURE (L4) NEMATODES:
Haemonchus contortus
Barber’s pole worm,
Trichostrongylus
spp
Black
scour
worm,
Trichostrongylus
axei
Stomach
hair
worm,
Trichostrongylus
colubriformis
,
Ostertagia
(Teladorsagia)
spp,
Ostertagia
(Teladorsagia)
circumcincta
Small
brown
stomach
worm,
Cooperia
spp
Small
intestinal
worm,
Cooperia
oncophora, Nematodirus
spp
Thin necked intestinal worm,
Nematodirus filicollis, Nematodirus
spathiger, Strongyloides papillosus
Intestinal threadworm,
Oesophagostomum columbianum
Nodule worm,
Chabertia ovina
Large mouthed bowel worm,
Dictyocaulus filaria
Large lungworm
ADULT
NEMATODES:
Trichostrongylus
rugatus,
Trichostrongylus
vitrinus,
Cooperia
curticei,
Nematodirus abnormalis, Nematodirus helvetianus, Ostertagia
trifurcata, Oesophagostomum
venulosum
Larg

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Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
CYDECTIN PLUS FLUKE
SOLUTION.DOC
REVISION B
SAFETY DATA SHEET
Product Name:
Cydectin Plus Fluke Oral Solution for Sheep
PAGE: 1 OF 6
DATE OF ISSUE
14 SEPTEMBER,
2015
EMERGENCY: VIRBAC: 02 9772 9772 OR 1800 242 100 (BUSINESS HOURS ONLY)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
COMPANY:
VIRBAC (AUSTRALIA) PTY. LTD
ABN 77 003 268 871
ADDRESS
361 Horsley Rd, Milperra, NSW 2214, Australia
Locked Bag 6000, Milperra Business Centre, NSW 1891, Australia
TELEPHONE:
(02) 9772 9772 or 1800 242 100
FAX:
(02) 9772 9773
EMERGENCY PHONE
As above during business hours; answering machine after hours
CHEMICAL NATURE:
Triclabendazole is a triazole derivative; moxidectin is a fermentation
product.
TRADE NAME:
CYDECTIN PLUS FLUKE ORAL SOLUTION FOR SHEEP
APVMA CODE:
63506
PRODUCT USE:
Veterinary drench for use as described on the product label.
CREATION DATE:
SEPTEMBER, 2010
THIS VERSION ISSUED:
SEPTEMBER, 2015
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as: Xi, Irritating. T, Toxic. N, Dangerous
to the environment. Hazardous according to the
criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA and IMDG/IMSBC criteria.
RISK PHRASES:
R22, R36/38, R48/22, R51/53. Harmful if swallowed. Irritating to eyes
and skin. Harmful: danger of
serious damage to health by prolonged exposure if swallowed. Toxic to
aquatic organisms, may cause long-term
adverse effects to the aquatic environment.
SAFETY PHRASES:
S20, S36, S60, S61, S24/25. When using, do not eat or drink. Wear
suitable protective clothing.
This material and its container must be disposed of as hazardous
waste. 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 u

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