Indications for use, specifying the target species
For the treatment and control of gastro-intestinal nematodes, lungworms, eyeworms, warbles, chorioptic and sarcoptic mange and sucking and biting lice in beef and nonlactating dairy cattle.
The product at the recommended dosage level of 500 μg ivermectin per kg bodyweight effectively controls the following parasites of cattle:
Gastrointestinal roundworms (adult and fourth stage larvae): Ostertagia ostertagi (including inhibited stage), Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia spp., Oesophagostomum radiatum, Strongyloides papillosus adult, Trichuris spp. adult,
Lungworms (adult and fourth stage larvae): Dictyocaulus viviparus
Eyeworms (adult): Thelazia spp.
Warbles (parasitic stages): Hypoderma bovis, H. lineatum
Mites: Sarcoptes scabiei var. bovis, Chorioptes bovis
Lice: Linognathus vituli Haematopinus eurysternus Solenopotes capillatus Damalinia bovis
The product, given at the recommended dosage of 500 micrograms per kg bodyweight, controls infections with Trichostrongylus axei and Cooperia spp acquired up to 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired during the first 21 days after treatment and Dictyocaulus viviparus (lungworm) acquired during the first 28 days after treatment. It also controls horn fly (Haematobia irritans) for up to 35 days after treatment.

Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients. The product has been formulated for topical application specifically in cattle. Do not apply or administer to other species as severe adverse reactions, including fatalities in dogs, may occur. Do not apply to areas of skin which have mange, scabs or other lesions or to areas contaminated with mud or manure.

Special warnings for each target species
Rainfall before or after treatment will not affect the efficacy of the product. Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: ·Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. ·Underdosing, which may be due to underestimation of body weight, misadministration of theproduct, or lack of calibration of the dosing device (if any). Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used. Resistance to macrocyclic lactones (which includes ivermectin) has been reported in Cooperia spp. and Ostertagia ostertagi in cattle within the EU. Therefore, the use of this and other similar macrocyclic lactone products should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

Special precautions for use in animals
For external use only.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
HIGHLY FLAMMABLE - KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME OR OTHER SOURCES OF IGNITION. The product may be irritating to human skin and eyes and the users should be careful not to apply it to themselves or others. Operators should wear rubber gloves and boots with a waterproof coat when applying the product. Protective clothing should be washed after use. Use only in well-ventilated areas or outdoors. As absorption through skin can occur, in the event of accidental skin contact the affected area should be washed immediately with soap and water. If irritation persists, seek medical advice and show the package leaflet or label to the physician. If accidental eye exposure occurs, flush the eyes immediately with water and get medical attention. Wash hands after use. Do not smoke, eat or drink while handling the product.

Other precautions
This product is very toxic to aquatic organisms, sediment dwelling organisms, and dung insects. Long-term effects on dung insects caused by continuous or repeated use cannot be excluded. Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment. The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of this product and other products of the same anthelmintic class. Therefore, the repetition of treatment in a pasture during a season should be performed only in the absence of alternative treatment and on veterinary advice.

Adverse reactions (frequency and seriousness)
Undesirable effects are not expected when the product is used at the recommended dose rate.

Use during pregnancy, lactation or lay
The product can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. The product will not affect the fertility of cows and bulls and can be given to all ages of animals including young calves.

Interaction with other medicinal products and other forms of interaction
Not known. The product may be used concurrently with foot and mouth disease vaccine or clostridial vaccine.

Amounts to be administered and administration route
For pour-on use. Dosage: 1 ml per 10 kg bodyweight (based on a recommended dosage level of 500 micrograms per kg bodyweight). Administration: The formulation should be applied along the mid-line of the back in a narrow strip between the withers and tailhead. The product should be used with appropriate dosing equipment. To ensure administration of correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Overdose (symptoms, emergency procedures, antidotes), if necessary
No sign of toxicity appeared up to 5 mg/kg (10 times the recommended dose rate). No antidote has been identified.

Withdrawal period(s)
Meat and offal: 15 days.
Do not use in animals producing milk for human consumption.
Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.