metadata toggle
Clinical particulars
Target species
Cattle
Indications for use
The product is indicated for the treatment of mixed trematode and nematode or arthropod infestations of the following parasites:
Gastrointestinal roundworms (adult and fourth-stage larvae):
Ostertagia ostertagi (including inhibited larval stages)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Bunostomum phlebotomum
Oesophagostamum radiatum
Strongyloides papillosus (adult)
N. spathiger (adult)
N. helvetianus (adult)
Lungworms (adult and fourth-stage larvae)
Dictyocaulus viviparus
Liver fluke (adult):
Fasciola hepatica
Eye worms (adult):
Thelazia spp
Warbles (parasitic stages):
Hypoderma bovis
H. lineatum
Mange mites:
Psoroptes bovis
Sarcoptes scabiei var. bovis
Sucking lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
The product may also be used as an aid in the control of biting lice (Bovicola/Damalinia bovis) and the mange mite Chorioptes bovis, but complete elimination may not occur.
Persistent activity
The product given at the recommended dosage of 1ml/50kg bodyweight controls re-infection with Haemonchus placei, Cooperia spp. and Trichostrongylus axei acquired up to 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and Dictyocaulus viviparus acquired up to 28 days after treatment.
Contra-indications
DO NOT USE intramuscularly or intravenously.
This product is a low volume product authorised for use in cattle. It must not be used in other species as severe adverse reactions, including fatalities in dogs, may occur, especially Collies, Old English Sheepdogs and related breeds or crosses.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
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 the product, 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 Ivermectin has been reported in Ostertagia ostertagi and Cooperia species in cattle within the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of these helminth species and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use
Special precautions for use in animals
This product does not contain any antimicrobial preservative. Swab septum before removing each dose.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke or eat whilst handling the product.
Wash hands after use.
Wear gloves and glasses when handling the veterinary medicinal product. Direct contact with the skin should be avoided.
Take care to avoid self-injection: the product may cause local irritation and/or pain at the injection site. In case of accidental self injection, seek medical advice and show the label to the doctor.
Other precautions
The product is very toxic to aquatic organisms and dung insects. Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment. Long term effects on dung insects caused by continuous or repeated use cannot be excluded. Therefore repeat treatments on a pasture within a season should only be given on the advice of a veterinarian.
Adverse reactions
Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions disappeared without treatment.
Use during pregnancy, lactation or lay
Can be used in pregnancy and lactation.
Can be used in breeding animals.
Interactions
None known.
Amounts to be administered and administration route
Dosage and duration of treatment
200μg ivermectin and 2mg clorsulon per kg bodyweight corresponding to a single dose of 1ml per 50kg bodyweight.
Method of administration
The product should be administered only by subcutaneous injection under the loose skin in front of or behind the shoulder.
Divide doses in excess of 10 ml between different injection sites and use different sites to those used for other parenteral medications.
Replace with a fresh sterile needle after every 10-12 animals or sooner if the needle becomes soiled.
When the temperature of the product is below 5°C, difficulty in administration may be encountered due to increased viscosity. Warming the product and injection equipment to about 15°C will greatly increase the ease with which the product can be injected.
When using the 500ml pack size use only automatic syringe equipment. For the 50ml pack size, use of a multidose syringe is recommended.
The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing program should be established by a qualified professional person.
To ensure a correct dosage, body weight 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, to avoid under- or over-dosing, they should be grouped according to their bodyweight and dosed accordingly.
Overdose
A dose of 25ml product per 50kg bodyweight (25 times the recommended dose level) may result in an injection site lesion, including tissue necrosis, oedema, fibrosis and inflammation. No other drug-related reactions have been observed.
Withdrawal periods
Meat and offal: 66 days
Milk: Do not use in cattle producing milk for human consumption.
Do not use in non-lactating dairy cattle including pregnant heifers within 60 days of calving.