Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

A clear pour-on solution containing ivermectin 0.5% w/v (5 mg/ml).

Uses

For the treatment and control of gastro-intestinal nematodes, lungworms, eyeworms, warbles, chorioptic and sarcoptic mange and sucking and biting lice in beef and non-lactating dairy cattle.

IVOMEC Classic Pour-On for Cattle at the recommended dose rate of 500 micrograms ivermectin per kg bodyweight effectively controls the following parasites of cattle:

			Inhibited
PARASITE	Adult	L4	L4
Gastrointestinal Roundworms:
Ostertagia ostertagi	•	•	•
Cooperia spp.	•	•
Haemonchus placei	•	•
Trichostrongylus axei	•	•
Trichostrongylus colubriformis	•	•
Oesophagostomum radiatum	•	•
Strongyloides papillosus	•
Trichuris spp.	•
Lungworms:
Dictyocaulus viviparus	•	•
Eye Worms:
Thelazia spp.	•
Warbles (parasitic stages):	Adult	Immature
Hypoderma bovis		•
H. lineatum		•
Mange Mites:
Chorioptes bovis	•	•
Sarcoptes scabiei var. bovis	•	•
Sucking Lice:
Linognathus vituli	•	•
Solenopotes capillatus	•	•
Haematopinus eurysternus	•	•
Biting Lice:
Damalinia bovis	•	•

IVOMEC Classic Pour-On for Cattle given at the recommended dosage of 500 micrograms/kg bodyweight controls re-infections with the following parasites of cattle:

	Prolonged activity
Haematobia irritans	up to 35 days
Dictyocaulus viviparus	up to 28 days
Ostertagia ostertagi	up to 21 days
Oesophagostomum radiatum	up to 21 days
Cooperia spp.	up to 14 days
Trichostrongylus axei	up to 14 days

To obtain optimal benefit from the persistent activity of IVOMEC Classic Pour-On for Cattle for grazing animals, it is recommended that calves which are set-stocked in their first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out. Studies have demonstrated that first-season grazing calves turned out to pasture in late April or May and treated with IVOMEC Classic Pour-On for Cattle 3, 8 and 13 weeks after turn-out can be protected from parasitic gastro-enteritis and lungworm disease throughout the grazing season, provided they are set-stocked, all the calves are included in the programme and that no untreated cattle are added to the pasture.

Treated calves should always be monitored according to good husbandry practices.

Rainfall before or after treatment will not affect the efficacy of IVOMEC Classic Pour-On.

Dosage and administration

Dosage

1 ml per 10 kg bodyweight (based on a recommended dosage level of 500 micrograms/kg bodyweight).

Administration

The formulation should be applied along the mid-line of the back in a narrow strip between the withers and tailhead.

Squeeze-Measure-Pour System (1 litre pack):

Attach the metering cup firmly to the bottle.

Set the dose by turning the top section of the cup to align the correct bodyweight with the pointer on the knurled cap of the cup. When bodyweight is between markings, use the higher setting.

Hold the bottle upright and squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines.

When the pressure is released, the dose automatically adjusts to the correct level. Tilt the bottle and dispense the solution.

NOTE - FOR 1 LITRE BOTTLE AND 50 ML DIAL-A-DOSE CAP.

When the 100 kg (10 ml) or 150 kg (15 ml) dose is required:

- turn cap to 10 ml or 15 ml mark.

- squeeze bottle and fill to mark.

- turn the pointer to "STOP" before dispensing the dose.

The STOP position will close the system.

Important - Keep upright when filling and during storage.

Close container when not in use.

Collapsible Pack (2.5 litre pack x 2 in a carton):

If the carton is opened for purpose of sale in single 2.5 L units, a package insert must be provided with each transaction.

Connect the Pour-On applicator to the collapsible pack as follows:

Attach the open end of the draw-off tubing to the pour-on applicator. **

Attach draw-off tubing to the cap with the stem. Replace the shipping cap with the cap that has the draw-off tubing. Tighten this draw-off cap.

Gently prime the Pour-On applicator, checking for leaks.

Follow manufacturer's directions for correct use and care of the equipment.

**An applicator compatible with the formulation is available for use with the 2.5 litre pack of IVOMEC Pour-On. Other applicators may be incompatible with the formulation, resulting in locking, incorrect dosage and leakage.

Contra-indications, warnings, etc

HIGHLY FLAMMABLE–KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME OR OTHER SOURCES OF IGNITION.

For animal treatment only.

For external use only.

Undesirable effects are not expected when IVOMEC Classic Pour-On for cattle is used at the recommended dose rate. No signs of toxicity appeared in trials up to 5mg/kg (10 times the recommended dose rate). No antidote has been identified.

Do not apply to areas of skin which have mange scabs or other lesions or to areas contaminated with mud or manure.

IVOMEC Classic Pour-On for Cattle has been formulated for topical application specifically in cattle. It should not be applied or administered to other species, as severe adverse reactions, including fatalities in dogs, may occur.

Withdrawal periods

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 15 days from the last treatment.

Do not use in cows producing milk for human consumption.

Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

Standard operator warnings

IVOMEC Classic Pour-On for Cattle may be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons. Operators should wear rubber gloves and boots with a waterproof coat when applying the product. Protective clothing should be washed after use. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with copious water and get medical attention.

Do not smoke or eat while handling the product.

Wash hands after use.

Use only in well ventilated areas or outdoors.

Container disposal

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Pharmaceutical precautions

Avoid extremes of temperature.

Protect from light.

Store in tightly closed, original container.

If stored at temperatures below 0°C IVOMEC Classic Pour-On for Cattle may appear cloudy. Allowing to warm at room temperature will restore the normal appearance without affecting efficacy.

Keep out of the reach and sight of children.

Legal category

POM-VPS

Packaging Quantities

1 litre squeeze-measure-pour bottles, 2.5 litre high density collapsible backpacks.

Further information

IVOMEC Classic Pour-On for Cattle can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. IVOMEC Classic Pour-On for Cattle will not affect the fertility of cows and bulls and can be given to all ages of animals including young calves.

Marketing authorisation number

Vm 08327/4169.