Pour-on solution.

Clear, colourless solution.

For treatment of infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.

Gastrointestinal roundworms (adults and fourth stage larvae)

Trichuris spp.1

1 adults

Lungworms (adults and fourth stage larvae)

Thelazia spp.

Warbles (parasitic stages)

Following product administration, efficacy against re-infection with the following parasites persists for the period indicated:

The product also controls horn flies (Haematobia irritans) for at least 42 days after treatment.

A single treatment of 1 ml (5 mg doramectin) per 10 kg bodyweight, equivalent to 500 µg/kg bodyweight, applied topically along the mid-line of the back in a narrow strip between the withers and tail head.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- and over- dosing.

Dosage table

The product has been formulated for topical application specifically for cattle. It should not be administered to other species as severe adverse reactions, including fatalities in dogs, may occur.

Do not use in cases of hypersensitivity to the active substance or any of the excipients.

In rare cases small skin lesions may occur at the administration site.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

For external use only.

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.

- under dosing, which may be due to underestimation of bodyweight,

misadministration of the product, or lack of calibration of a dosing device (if any).

Resistance to doramectin and other avermectins has been reported in gastro-intestinal nematodes, especially Cooperia oncophera and Ostertagia ostertagi, in cattle. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of the target nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

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 a different pharmacological class and having a different mode of action should be used.

Do not apply to areas of skin that are contaminated with mud or manure.

Therapeutic efficacy for internal and external parasites is not affected by heavy rainfall (2 cm in 1 hour) either before (20 minutes) or after (20 and 40 minutes) treatment. The influence of extreme weather conditions on efficacy is unknown.

Avermectins may not be well tolerated in all non-target species. Cases of intolerance with fatal outcome are reported in dogs, especially Collies, old English Sheepdogs and related breeds or crosses, and also in turtles/tortoise. Care should be taken to avoid ingestion of spilled product or access to containers by these other species.

To avoid secondary reactions due to death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the product at the end of the period of warble fly activity and before the larvae reach their resting sites. Consult your veterinary surgeon on the correct timing of treatment.

Disease associated with warble fly is notifiable in some regions.

People with known hypersensitivity to the active substance should avoid contact with the product. Do not smoke or eat while handling the product. Wash hands after use. The product may be irritating to human skin and eyes and users should be careful not to apply it to themselves or to 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 irritation persists, seek medical attention. If accidental eye exposure occurs, flush the eyes immediately with clean water and get medical attention. Avoid accidental inhalation of this product, as this may cause drowsiness and dizziness. Use only in well ventilated areas or outdoors.

Highly Flammable - Keep away from heat, sparks, open flame or other sources of ignition.

Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.

The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle.

The risk to aquatic ecosystems will be reduced by keeping treated cattle away from water bodies for five weeks after treatment.

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

Do not refrigerate

Protect from light

The product will be supplied in:

- 1 L, 2.5 L, 3 L, 5 L, 6 L (5L + 1 L) and 8 L (5 L + 3 L) high-density polyethylene bottles with a tamper evident cap in a carton box.

Not all pack sizes may be marketed

C&H Generics Limited

c/o Michael McEvoy & Co.

Seville House

New Dock Street

Galway

Ireland

Shelf life of the veterinary medicinal product as packaged for sale: 5 years

Shelf life after first opening the immediate packaging: 1 year

Vm 40162/4038