Microsoft word - combi lab_jb1feb04.doc

Product name: Combi Oral Drench for Sheep and Lambs
Date: 19 February 2004
Page: 1 of 5
Pack sizes: 10L, 20 L
Type of label: Composite: Primary label
File: COMBI lab_JB1Feb04.doc
Version: 10
Reason: Add APVMA nos. (JB)
Text above this line is not included in the actual label.
Primary label (front panel)
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
FOR ANIMAL TREATMENT ONLY
ORAL DRENCH FOR SHEEP AND LAMBS
ACTIVE CONSTITUENTS: 36.0 g/L albendazole oxide (equivalent to 34.0 g/L Albendazole)
82.5 g/L levamisole hydrochloride (equivalent to 70.0 g/L levamisole)
For the control of gastrointestinal roundworms, sensitive to benzimidazoles
and levamisole including those resistant to either benzimidazoles or levamisole.
For the control of lungworm and tapeworm. Reduces the output of worm eggs.

roundworm
lungworm
tapeworm
reduces worm egg output

10 [ 20 ] LITRES
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED
A.C.N. 076 745 198
54 Waterloo Road,
North Ryde NSW 2113

* Ricobendazole™
Product name: Combi Oral Drench for Sheep and Lambs
Date: 19 February 2004
Page: 2 of 5
Pack sizes: 10L, 20 L
Type of label: Composite: Primary label
File: COMBI lab_JB1Feb04.doc
Version: 10
Reason: Add APVMA nos. (JB)
Text above this line is not included in the actual label.
Primary label (back panel)
C O M B I
ORAL DRENCH FOR SHEEP AND LAMBS

ACTIVE CONSTITUENTS: 36.0 g/L albendazole oxide (equivalent to 34.0 g/L Albendazole)
82.5 g/L levamisole hydrochloride (equivalent to 70.0 g/L levamisole) EFFICACY SPECTRUM MATURE AND IMMATURE
For the control 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.
ROUNDWORMS
Small brown stomach worm………………… (Ostertagia spp.)
Black scour worm……………………………. (Trichostrongylus spp.)
Stomach hair worm…………………………. (Trichostrongylus axei)
Barbers pole worm…………………………… (Haemonchus contortus)
Thin necked intestinal worm………………… (Nematodirus spp.)
Small intestinal worm………………………… (Cooperia spp.)
Hookworm……………………………………. (Bunostomum spp.)
Nodule worm…………………………………. (Oesophagostomum columbianum)
Large bowel worm……………………………. (Oesophagostomum venulosum)
Large mouthed bowel worm………………… (Chabertia ovina)
LUNGWORM
Large lungworm
TAPEWORM
Heads and segments
OVICIDAL

Resistance may develop to any drench.

DIRECTIONS FOR USE
Restraint
DO NOT USE in ewes producing milk or milk products for human consumption.

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.

Product name: Combi Oral Drench for Sheep and Lambs
Date: 19 February 2004
Page: 3 of 5
Pack sizes: 10L, 20 L
Type of label: Composite: Primary label
File: COMBI lab_JB1Feb04.doc
Version: 10
Reason: Add APVMA nos. (JB)
Text above this line is not included in the actual label.
SHAKE CONTAINER BEFORE USE.
Dosage and administration
1 mL Combi drench per 10 kg bodyweight. Drench sheep orally, using an appropriate drench gun.

DOSE RATES FOR SHEEP
Roundworm, lungworm, and tapeworm
- Give 1 mL Combi drench for every 10 kg bodyweight.
Bodyweight
Roundworm
No. treated per 10 L
No. treated per 20 L
Lungworm
Tapeworm
Sheep in excess of 75 kg bodyweight should be dosed at 1 mL/10 kg bodyweight. A representative sample of animals should be weighed before treatment. Drench the mob to the heaviest sheep by liveweight in each group (ewes, wethers, rams, lambs). Where there is a large variation in size within the group, dose rate should be based on the label directions for each weight range. Drafting into two or more lines may be appropriate, to avoid excessive overdosing. Worm parasites may develop resistance to any anthelmintic. Ask your veterinarian or animal health adviser for recommended parasite management practices for your area to reduce the development of resistance.
It is advisable that an anthelmintic resistance test be conducted before any anthelmintic is used.
Treatment of liver fluke
To treat liver fluke (Fasciola hepatica) in addition to roundworm, lungworm and tapeworm, mix
FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats (100 g/L triclabendazole) and COMBI
drench according to the instructions below.

Shake container of each product before mixing. Into an appropriately labeled plastic container,
mix equal volumes of FASINEX 100 and COMBI drench. Prepare only enough mixture for the
required numbers of sheep to be treated (refer to table below). Use mixture within 7 days of
preparing. Always remix thoroughly when using a previously prepared mixture and discard any
mixtures older than 7 days.
Dosage and administration
Give 2 mL FASINEX 100/COMBI drench for every 10 kg bodyweight. Drench sheep orally, using
an appropriate drench gun.
Product name: Combi Oral Drench for Sheep and Lambs
Date: 19 February 2004
Page: 4 of 5
Pack sizes: 10L, 20 L
Type of label: Composite: Primary label
File: COMBI lab_JB1Feb04.doc
Version: 10
Reason: Add APVMA nos. (JB)
Text above this line is not included in the actual label.
FASINEX 100/COMBI drench mixture
Bodyweight
Liver fluke,
No. treated per 10 L
No. treated per 20 L
Roundworm
Lungworm
(5 L of FASINEX 100 +
(10 L of FASINEX 100
Tapeworm
5 L of COMBI drench)
+ 10 L of COMBI
Sheep in excess of 75 kg bodyweight should be dosed at 2 mL/10 kg bodyweight.
___________________________________________________________________________
WITHHOLDING PERIODS for the FASINEX 100/COMBI drench mixture
MEAT - DO NOT USE less than 21 days before slaughter for human consumption.

EXPORT SLAUGHTER INTERVAL: 63 days

MILK - DO NOT USE in lactating animals where milk or milk products may be used for
human consumption.

WITHHOLDING PERIODS (for COMBI used alone)
MEAT: DO NOT USE less than 10 days before slaughter for human consumption.

EXPORT SLAUGHTER INTERVAL: 10 days

MILK: DO NOT USE on ewes producing milk or milk products for human consumption.


SAFETY DIRECTIONS
Poisonous if swallowed. Harmful if absorbed by skin contact. May irritate the eyes and
skin. Avoid contact with eyes and skin. Wear rubber gloves. Wash hands after use.
FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (Ph: 131126).

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
Triple rinse containers before disposal and dispose of rinsate below 500 mm in a disposal pit
specifically marked and set up for this purpose clear of waterways, vegetation and roots. Do not
dispose of undiluted chemicals on-site. Break, crush or puncture and bury empty containers in a
local authority landfill. If no landfill is available, bury the containers below 500 mm in a disposal pit
as described above. Empty containers and product should not be burned.

WARRANTY AND EXCLUSION OF LIABILITY
Product name: Combi Oral Drench for Sheep and Lambs
Date: 19 February 2004
Page: 5 of 5
Pack sizes: 10L, 20 L
Type of label: Composite: Primary label
File: COMBI lab_JB1Feb04.doc
Version: 10
Reason: Add APVMA nos. (JB)
Text above this line is not included in the actual label.
This product is warranted fit for the purposes specifically recommended by Novartis Animal Health
Australasia Pty Limited when used strictly as directed on this label. All other warranties and
obligations or liabilities, whether expressed or implied by statute or otherwise, are excluded to the
full extent that exclusion is permitted by law.
NOVARTIS CUSTOMER ASSISTANCE 1800 633 768 TOLL FREE from anywhere in Australia
8:30 am to 5:30 pm EST Monday to Friday.
APVMA Approval No. 51611/10L/ 0503
APVMA Approval No. 51611/20L/ 0503
STORAGE CONDITIONS
Store below 30°C (room temperature) in original container, tightly closed in a safe place.
Batch Number

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

Source: http://www.agtech.com.au/label/novartisah/combi_24104519.pdf

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