Indications for use, specifying the target species
For treatment of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.
Gastrointestinal roundworms (adults and fourth stage larvae)
Ostertagia ostertagi (inc. inhibited larvae)
C. surnabada1 (syn. mcmasteri)
Lungworms (adults and fourth stage larvae)
Warbles (parasitic stages)
Damalinia (Bovicola) bovis
Duration of activity
The veterinary product protects cattle against infection or re-infection with the following parasites for the periods indicated.
Damalinia (Bovicola) bovis
The veterinary product also controls horn flies (Haematobia irritans) for at least 42 days after treatment.
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, may occur. See section, "Special precautions for use in animals".
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
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.
Special precautions for use
i. Special precautions for use in animals.
Avermectins may not be well tolerated in all non-target species. Cases of intolerance with fatal outcome have been reported in dogs, especially Collies, old English Sheepdogs and related breeds or crosses, and also in chelonia (turtles and tortoises). 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 veterinary 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.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals.
Persons 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 veterinary 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 accidental eye exposure occurs, flush the eyes immediately with water and get medical attention. Use only in well ventilated areas or outdoors.
Highly Flammable - Keep away from heat, sparks, open flame or other sources of ignition.
iii. Other precautions
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 and sheep.
The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment
Adverse reactions (frequency and seriousness)
In rare cases (more than 1 but less than 10 animals in 10,000 animals treated) small skin lesions may occur at the administration site.
Use during pregnancy, lactation or lay
Do not use in non-lactating dairy cows, including pregnant heifers, within 60 days prior to calving.
Interaction with other medicinal products and other forms of interaction
Amounts to be administered and administration route
For topical use: pour-on application
A single treatment of 500 µg of doramectin/kg bodyweight equivalent to 1 ml of product per 10 kg bodyweight, applied topically along the mid-line of the back in a narrow strip between the withers and tailhead.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdoses up to 5 times the label recommended dose resulted in no clinical signs that could be attributed to treatment with doramectin.
Meat and offal: 35 days.
Not permitted for use in lactating animals producing milk for human consumption. Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months (60 days) of expected parturition.