Target species
Cattle
Indications for use
For the treatment of mixed trematode and nematode or arthropod infestations, due to adult and immature roundworms, lungworms, warbles, mites, lice and liver fluke in cattle.
Gastro-intestinal roundworms (adult and fourth-stage larvae):
Ostertagia ostertagi (including inhibited larval stages)
O.lyrata
Haemonchus placei
Trichostrongylus axei
Trichostrongylus colubriformis
Cooperia oncophora
Cooperia punctata
Cooperia pectinata
Bunostomum phlebotomum
Oesophagostomum radiatum
Strongyloides papillosus (adult)
Nematodirus helvetianus (adult)
Nematodirus spathiger (adult)
Lungworms (adult and fourth-stage larvae):
Dictyocaulus viviparus
Liver fluke (adult):
Fasciola hepatica
Warbles (parasitic stages):
Hypoderma bovis
Hypoderma lineatum
Mange mites:
Psoroptes bovis
Sarcoptes scabiei var. bovis
Sucking lice:
Linognathus vituli
Haematopinus eurysternus
The veterinary medicinal product may also be used as an aid in the control of the mange mite Chorioptes bovis, but complete elimination may not occur.
Contra-indications
Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.
Not for use in species other than cattle as severe adverse reactions, including fatalities, may occur in dogs for example.
Do not use by the intravenous or intramuscular route.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings
Care should be taken to avoid the following practices because they increase the risk of the 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 macrocyclic lactones (which includes ivermectin) has been reported in Ostertagia ostertagi and Cooperia spp, in cattle within the EU. Therefore the use of this product 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
Special precautions for safe use in the target species:
Divide doses greater than 10 ml between two injection sites to reduce occasional discomfort or site reaction.
Frequent and repeated use may lead to the development of resistance.
The timing of treatment for the parasitic stages of warbles should be chosen carefully. The best time to treat against infections with Hypoderma is immediately after the end of the swarming of the warbles, before the larvae cause damage in the body of the animal (October to November). If larvae of Hypoderma bovis are killed during migration through the spine, this may induce posterior paralysis and recumbency. These reactions occur mainly when animals are treated between December and March.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
Do not smoke, drink or eat while handling the veterinary medicinal product.
Wash hands after use.
Avoid contact with skin and eyes.
Take care to avoid self-administration, the veterinary medicinal product may cause irritation and/or pain at the site of injection.
Special precautions for the protection of the environment:
Ivermectin is highly toxic to aquatic invertebrates. Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment to avoid adverse effects on aquatic organisms.
Other precautions:
Avermectins may not be well tolerated in non-target species. Cases of intolerance resulting in fatalities have been reported in dogs, especially Collies, Old English Sheep Dogs and related breeds or crosses, and also in turtles/tortoises.
Adverse events
Cattle
Undetermined frequency (cannot be estimated from the available data) | Discomfort1 Injection site swelling2, Injection site pain2,3 Hypersensitivity reaction4 |
1Transitory.
2Soft-tissue reactions, disappeared without treatment.
3Slight.
4Symptomatic treatment should be applied.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.
Interaction with other medicinal products and other forms of interaction
Not known.
Administration routes and dosage
Subcutaneous use.
The veterinary medicinal product should be given once by subcutaneous injection at the recommended dosage level of 200 mcg ivermectin and 2 mg clorsulon per kilogram of bodyweight. Each ml contains 10 mg of ivermectin and 100 mg of clorsulon, sufficient to treat 50 kg of bodyweight. Subcutaneous injection only.
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- or over-dosing.
Divide doses greater than 10 ml between two injection sites.
Inject under the loose skin behind the shoulder. Use of a 17-gauge, ½-inch (15- 20 mm) needle is suggested. The injection may be given with any standard automatic, multidose or single-dose hypodermic syringe. If using a hypodermic syringe, use a separate sterile needle to withdraw the dose from the pack.
This product does not contain an antimicrobial preservative. Swab septum before removing each dose.
Use a dry, sterile needle and syringe.
For 200, 500 and 1000-ml pack sizes, use only automatic-syringe equipment.
Injection on animals with wet or dirty hides is not recommended.
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. Different injection sites should be used for other parenteral products.
The timing for treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing programme should be established by the veterinary surgeon.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
An acute toxic syndrome consisting of CNS signs of depression and listlessness, ataxia, recumbency and possible death occurs in cattle given S.C. doses equal to 40 times the therapeutic dose for ivermectin. Treatment should be symptomatic.
A toxic-syndrome dose level has not been identified in cattle for clorsulon.
Withdrawal periods
Meat and offal: 66 days,
Not authorised for use in animals producing milk for human consumption.
Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.