VIRBAC COMBAT DUO WITH SELENIUM ORAL ANTHELMINTIC FOR SHEEP

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

22-06-2017

Summary of Product characteristics (SPC)

22-06-2017

Active ingredient:

LEVAMISOLE AS LEVAMISOLE HYDROCHLORIDE; FENBENDAZOLE; SELENIUM AS SODIUM SELENATE

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

levamisole as HCl(67.8g/L)+fenbendazole(50g/L) + others

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

LEVAMISOLE AS LEVAMISOLE HYDROCHLORIDE ANTHELMINTIC Active 67.8 g/L; FENBENDAZOLE CARBAMATE-BENZIMIDAZOLE Active 50.0 g/L; SELENIUM AS SODIUM SELENATE MINERAL-SELENIUM Active 1.0 g/L

Units in package:

10L; 3.3L

Class:

VP - Veterinary Pesticide

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 6; Withholding period: WHP: MEAT - DO NOT USE less than 14 day s before slaughter for human consumptio n. MILK - Milk collected from ewes with in 3 days of treatment MUST NOT BE USED for human consumption or processing o r fed to bobby calves and sucking lambs .; Host/pest details: LAMB: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., HOOKWORM - BUNOSTOMUM SPP., INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, NODULE WORM - OESOPHAGOSTOMUM SPP., SELENIUM DEFICIENCY, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , TAPEWORM, THIN NECKED INTESTINAL WORM]; SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., HOOKWORM - BUNOSTOMUM SPP., INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, NODULE WORM - OESOPHAGOSTOMUM SPP., SELENIUM DEFICIENCY, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , TAPEWORM, THIN NECKED INTESTINAL WORM]; Poison schedule: 6; Withholding period: ; Host/pest details: LAMB: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., HOOKWORM - BUNOSTOMUM SPP., INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, NODULE WORM - OESOPHAGOSTOMUM SPP., SELENIUM DEFICIENCY, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , TAPEWORM, THIN NECKED INTESTINAL WORM]; SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., HOOKWORM - BUNOSTOMUM SPP., INTESTINAL THREADWORM - S. PAPILLOSUS, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, NODULE WORM - OESOPHAGOSTOMUM SPP., SELENIUM DEFICIENCY, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , TAPEWORM, THIN NECKED INTESTINAL WORM]; For control of levamisole and fenbendazole sensitive mature and immature roundworms in sheep and lambs and as an aid in controlling selenium deficiencies in sheep and lambs.Milk collected for ewes within 3 days of treatment MUST NOT BE USED for human consumption or processing, or fed to bobby calves/ suckling lambs. USE the product only in areas of known selenium deficiency and seek veterinary advice to establish selenium

Authorization status:

Stopped

Authorization date:

2021-07-01

Patient Information leaflet

DIRECTIONS FOR USE:
SHAKE WELL BEFORE USE. NOT FOR USE IN GOATS.
RESTRAINTS:
MILK: MILK COLLECTED FROM EWES WITHIN 3 DAYS OF TREATMENT MUST NOT BE
USED FOR HUMAN CONSUMPTION OR PROCESSING, OR FED TO BOBBY
CALVES/SUCKLING LAMBS.
USE THE PRODUCT ONLY IN AREAS OF KNOWN SELENIUM DEFICIENCY AND SEEK
VETERINARY ADVICE TO ESTABLISH SELENIUM DEFICIENCY BEFORE USING THE
PRODUCT.
DO NOT USE THE PRODUCT WHEN SELENIUM IS PROVIDED BY OTHER MEANS EG
PASTURE TOP DRESSING, VACCINE, BOLUSES OR PELLETS.
PRECAUTIONS: DO NOT ADMINISTER TO SHEEP AND LAMBS GRAZING PASTURE
KNOWN TO BE HIGH IN SELENIUM OR WHERE THE SELENIUM ACCUMULATOR PLANTS
SUCH AS _NEPTUNIA AMPEXICAULIS_ AND _MORINDA RETICULATA _ARE KNOWN TO
OCCUR.
SELENIUM CAN HAVE TOXIC EFFECTS, PARTICULARLY IN SHEEP WITH LIVER
DAMAGE THAT GRAZE IN AREAS WHERE PLANTS THAT CONTAIN PYRROLIZIDINE
ALKALOIDS
ARE PREVALENT.
COMBAT DUO WITH SELENIUM contains Levamisole, a member of the
imidazothiazole (“clear”) family
of chemicals and fenbendazole, a member of the benzimidazole
(“white”) family of chemicals. It is
effective against sensitive and single-resistant mature and immature
strains of the roundworms and
lungworms listed below, and to aid in control of tapeworms and
selenium deficiencies in sheep and lambs:
_(Haemonchus contortus)_ Barber’s pole worm
_(Ostertagia _spp._)_ Small brown stomach worm
_(Trichostrongylus _spp._) _Black scour worm
_(Cooperia _spp._)_ Small intestinal worm
_(Nematodirus _spp._)_ Thin necked intestinal worm_ (Strongyloides
papillosus)_ Intestinal threadworm
_(Bunostomum _spp._) _Hookworm
_(Oesophagostomum _spp._)_ Nodule worm
_(Chabertia ovina) _Large mouthed bowel worm
_(Dictyocaulus filaria)_ Large lungworm
It will aid in the control of (_Moniezia_ spp.) Tapeworm.
Sheep in excess 75 kg to be dosed at 1 mL per 10 kg bodyweight. A
representative sample of animals
should be weighed before treatment. Dose the mob to the heaviest
animal by liveweight in each group
(ewes, wethers, rams, lambs). Do not underdose. Where there is a large
variation in siz

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Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
COMBAT DUO.DOC
REVISION C
SAFETY DATA SHEET
Product Name:
Combat Duo with Selenium Oral Anthelmintic for Sheep
PAGE: 1 OF 5
DATE OF ISSUE
13 AUGUST, 2014
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:
Blend of anthelmintic ingredients and selenium.
TRADE NAME:
COMBAT DUO WITH SELENIUM ORAL ANTHELMINTIC FOR SHEEP
PRODUCT CODE:
COMBATDUOSEL3.3; COMBATDUOSEL010
PRODUCT USE:
Veterinary drench for use as described on the product label.
CREATION DATE:
APRIL, 2004
THIS VERSION ISSUED:
AUGUST, 2014
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
This product is classified as:
Hazardous according to the criteria of SWA Australia.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA and IMDG/IMSBC criteria.
RISK PHRASES:
R21/22, R33. Harmful in contact with skin and if swallowed. Danger of
cumulative effects.
SAFETY PHRASES:
S2, S20, S24. Keep out of reach of children. When using, do not eat or
drink. Avoid contact with
skin.
SUSMP CLASSIFICATION:
S6
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
GHS SIGNAL WORD: WARNING.
HAZARD STATEMENT:
H302: Harmful if swallowed.
H312: Harmful in contact with skin.
H373: May cause damage to organs through prolonged or repeated
exposure.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
RESPONSE
P314: Get

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