COMBI PLUS SELENIUM ORAL DRENCH FOR SHEEP AND LAMBS

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
LEVAMISOLE AS LEVAMISOLE HYDROCHLORIDE; ALBENDAZOLE AS ALBENDAZOLE OXIDE; SELENIUM AS SODIUM SELENATE
Available from:
Elanco Australasia Pty Ltd
INN (International Name):
albendazole as oxide(34g/L)+levamisole as HCl(70g/L) + others
Pharmaceutical form:
ORAL SOLUTION/SUSPENSION
Composition:
LEVAMISOLE AS LEVAMISOLE HYDROCHLORIDE ANTHELMINTIC Active 70.0 g/L; ALBENDAZOLE AS ALBENDAZOLE OXIDE CARBAMATE-BENZIMIDAZOLE Active 34.0 g/L; SELENIUM AS SODIUM SELENATE MINERAL-SELENIUM Active 1.0 g/L
Units in package:
10L
Class:
VP - Veterinary Pesticide
Manufactured by:
ELANCO AUSTRALASIA
Therapeutic group:
LAMB | SHEEP | EWE | HOGGET | LAMB | OVINE | RAM | WEANER | WETHER
Therapeutic area:
PARASITICIDES
Therapeutic indications:
BARBER'S POLE WORM-HAEMONCHUS CONTORTUS | BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP. | HOOKWORM - BUNOSTOMUM SPP. | LARGE BOWEL WORM - O. VENULOSUM | LARGE LUNGWORM - DICTYOCAULUS FILARIA | LARGE MOUTHED BOWEL WORM | LUNGWORM - EGGS | NODULE WORM - O. COLUMBIANUM | ROUNDWORM - EGGS | SELENIUM DEFICIENCY | SMALL BROWN STOMACH WORM-OSTERTAGIA SPP. | SMALL INTESTINAL WORM - COOPERIA SPP. | STOMACH HAIR WORM | TAPEWORM - MONIEZIA SPP. | THIN NECKED INTESTINAL WORM | HAIR WORM | INTESTINAL HAIR WORM | SMALL HAIR WORM | TAPEWORM - HEADS/SEGMENTS | TELADORSAGIA | WHITE MUSCLE DISEASE
Product summary:
Poison schedule: 6; Withholding period: WHP: (for the FASINEX 100/COMBI plus S elenium drench mixture) MEAT: Do not us e less than 21 days before slaughter fo r human consumption. MILK: Do not use o n sheep which are producing or may in t he future produce milk or milk products for human consumption or processing. ESI: Do not use less than 63 days before slaughter for export. WHP: (for COMBI Plus Selenium used alone) MEAT: Do no t use less than 10 days before slaughte r for human consumption. MILK: Do not u se on sheep which are producing or may in the future produce milk or milk prod ucts for human consumption or processin g. ESI: Do not use less than 10 days be fore slaughter for export.; Host/pest details: LAMB: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., HOOKWORM - BUNOSTOMUM SPP., LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, LUNGWORM - EGGS, NODULE WORM - , ROUNDWORM - EGGS, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , STOMACH HAIR WORM, TAPEWORM - MONIEZIA SPP., THIN NECKED INTESTINAL WORM]; SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., HOOKWORM - BUNOSTOMUM SPP., LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, LUNGWORM - EGGS, NODULE WORM - , ROUNDWORM - EGGS, SELENIUM DEFICIENCY, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , STOMACH HAIR WORM, TAPEWORM - MONIEZIA SPP., 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., LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, LUNGWORM - EGGS, NODULE WORM - , ROUNDWORM - EGGS, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , STOMACH HAIR WORM, TAPEWORM - MONIEZIA SPP., THIN NECKED INTESTINAL WORM]; SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP., HOOKWORM - BUNOSTOMUM SPP., LARGE BOWEL WORM - O. VENULOSUM, LARGE LUNGWORM - DICTYOCAULUS FILARIA, LARGE MOUTHED BOWEL WORM, LUNGWORM - EGGS, NODULE WORM - , ROUNDWORM - EGGS, SELENIUM DEFICIENCY, SMALL BROWN STOMACH WORM-OSTERTAGIA SPP., SMALL INTESTINAL WORM , STOMACH HAIR WORM, TAPEWORM - MONIEZIA SPP., THIN NECKED INTESTINAL WORM]; For control of G.I. roundworms, sensitive to benzimidazoles and levamisole inc. those resistant to benzimidazoles or levamisole. For control of lungworm & tapeworm. Reduces the output of viable worm eggs. Aids in control of selenium deficiencies in sheep.DO NOT USE in ewes producing milk for human consumption or processing. See other Restraints on label also.
Authorization status:
Registered
Authorization number:
51595
Authorization date:
2020-07-01

Dieline

PMS 376

4 Colour Process

161961

02 Combi + Sel 10L Front

Novartis

25/02/2009

301124

For the control of gastro-intestinal

roundworms, sensitive to benzimidazoles

and levamisole including those resistant

to benzimidazoles or levamisole.

For the control of lungworm and tapeworm.

Reduces the output of viable worm eggs.

Aids in the control of selenium deficiencies

in sheep.

Oral Drench for Sheep and Lambs

180mm wide

165mm deep

ACTIVE CONSTITUENTS: 36.0 g/L ALBENDAZOLE OXIDE*

(equivalent to 34.0 g/L ALBENDAZOLE)

82.5 g/L LEVAMISOLE HYDROCHLORIDE

(equivalent to 70 g/L LEVAMISOLE)

1 g/L SELENIUM AS SODIUM SELENATE

*Ricobendazole™

SCALE: 100% when printed on A3 paper

APPROVED

LABEL

Info

pest

Verified

Dieline

180mm wide

165mm deep

PMS 376

PMS 485

Black

161961

07 Combi + Sel 10L Back

Novartis

18/11/2009

301126

WITHHOLDING PERIODS (for COMBI Plus Selenium used alone)

MEAT:

DO NOT USE less than 10 days before slaughter for human consumption.

MILK:

DO NOT USE on sheep which are producing or may in the future produce milk or milk products

for human consumption or processing.

TRADE ADVICE

EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE less than 10 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).

ACTIVE CONSTITUENTS:

36.0 g/L ALBENDAZOLE OXIDE* (equivalent to 34.0 g/L ALBENDAZOLE)

82.5 g/L LEVAMISOLE HYDROCHLORIDE (equivalent to 70 g/L LEVAMISOLE)

1 g/L SELENIUM AS SODIUM SELENATE

*Ricobendazole™

COMBI PLUS SELENIUM contains albendazole, a member of the benzimidazole family of drenches,

and levamisole, a member of the imidazothiazole family of drenches. It is effective against susceptible

strains of the following worms, including benzimidazole or levamisole resistant worms. This product is

NOT effective against worms that are resistant to BOTH benzimidazole and levamisole compounds.

EFFICACY SPECTRUM (MATURE AND IMMATURE)

DIRECTIONS FOR USE

Restraints

DO NOT USE on sheep which are producing or may in the future produce milk or milk

products for human consumption or processing.

Contraindications

This product should not be used when selenium intake from pasture is high or selenium

is provided by other means (such as top dressing, vaccine, pellets or selenium drenches)

or if blood selenium levels at treatment are high. Users can determine selenium status

by consulting their veterinarian.

This product should not be administered to sheep or lambs grazing pasture known to be

high in selenium or where selenium accumulating plants are know to occur (eg: SE QLD).

General Directions

This product contains selenium and should be used only in selenium deficient areas.

This product should only be used when drenching is required according to the particular program to control

roundworms and lungworms. If selenium is required at other times, it should be administered by way of other products.

To help control White Muscle Disease in lambs, treat pregnant ewes every 2-6 weeks prior to lambing and at

lamb marking. On properties where selenium responsive illthrift has been diagnosed, treat lambs at marking

and again 6-10 weeks later.

Precautions

Exercise care in handling weak, pregnant and young animals to avoid unnecessary stress.

Avoid yarding animals off-feed overnight and ensure animals have access to water when yarded prior to drenching.

Recommended dose should NOT be exceeded except under veterinary supervision.

Maintain applicator gun carefully to ensure accurate dosage. Before and after use, clean gun by flushing out

with cold water. DO NOT use hot water.

SHAKE THE CONTAINER WELL BEFORE USE.

Dosage and Administration

1 mL COMBI PLUS SELENIUM per 10 kg bodyweight. Drench sheep orally, using an appropriate drench gun. Roundworm,

lungworm, and tapeworm - give 1 mL COMBI PLUS SELENIUM for every 10 kg bodyweight.

301125

Oral Drench for Sheep and Lambs

GASTRO-INTESTINAL ROUNDWORMS

LUNGWORM

TAPEWORM

OVICIDAL

No. treated per 10 L

Bodyweight kg

Roundworm, Lungworm, Tarpeworm mL

SCALE: 100% when printed on A3 paper

APPROVED

LABEL

Dieline

180mm wide

165mm deep

PMS 376

Process Yellow

PMS 485

Black

161961

04 Combi + Sel 10L Left

Novartis

2/12/2009

301126

WITHHOLDING PERIODS for the FASINEX 100/COMBI Plus Selenium drench mixture

MEAT:

DO NOT USE less than 21 days before slaughter for human consumption.

MILK:

DO NOT USE on sheep which are producing or may in the future produce milk or milk products for

human consumption or processing.

TRADE ADVICE

EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE less than 63 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).

Oral Drench for Sheep and Lambs

SCALE: 100% when printed on A3 paper

APPROVED

LABEL

DO NOT contaminate dams, rivers or streams with the drench or used container.

APVMA Approval No: 51595/10L/0609

NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED

A.C.N. 076 745 198

54 Waterloo Road, North Ryde NSW 2113

™ Trademark of Novartis AG, Basel, Switzerland

Dieline

180mm wide

165mm deep

PMS 376

PMS 485

Black

161961

06 Combi + Sel 10L Right

Novartis

12/11/2009

301127

Oral Drench for Sheep and Lambs

SAFETY DIRECTIONS

Harmful if swallowed or absorbed by skin contact. May irritate the eyes and skin. Avoid contact with eyes

and skin. When opening the container and pouring large quantities, wear elbow-length PVC gloves. Wash

hands after use.

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.

Protection of Wildlife, Fish, Crustaceans and the Environment

SCALE: 100% when printed on A3 paper

APPROVED

LABEL

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