Target species
Cattle.
Indications for use
The veterinary medicinal product is indicated for the treatment and control of the following parasites:
Gastrointestinal Roundworms (Adult and fourth-stage larva):
Ostertagia ostertagi
Ostertagia lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Bunostomum phlebotomum
Oesophagostomum radiatum
Strongyloides papillosus (adult)
Nematodirus helvetianus (adult)
N. spathiger (adult)
Trichuris spp. (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 veterinary medicinal product may also be used as an aid in the control of biting lice (Damalinia bovis) and the mange mite (Chorioptes bovis), but complete elimination may not occur.
Persistent Activity
The veterinary medicinal product given at the recommended dosage of 0.2 mg per kg 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.
The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing programme should be established by a qualified professional person.
Contraindications
Do not use intramuscularly or intravenously. The veterinary medicinal product is a low-volume product registered for use in cattle. Do not use in other species as severe adverse reactions, including fatalities in dogs, may occur. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Special warnings
For use only in beef cattle and non-lactating dairy cattle. 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 bodyweight, misadministration of the product, or lack of calibration of the dosing device.
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. 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 safe use in the target species:
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, drink or eat while handling the veterinary medicinal product. Wash hands after use. Take care to avoid self-injection as the veterinary medicinal product may cause local irritation and/or pain at the injection site.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cattle:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): Injection site swelling1, discomfort1
1 following subcutaneous injection, resolves without treatment.
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 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: The veterinary medicinal product can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption.
Fertility: The veterinary medicinal 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
None known.
Administration routes and dosage
Subcutaneous. The veterinary medicinal product should be administered only by subcutaneous injection at the recommended dosage level of 1 ml/50 kg bodyweight (based on a dosage level of 200 mcg ivermectin plus 2 mg clorsulon per kg bodyweight) under the loose skin in front of, or behind, the shoulder. Divide doses greater than 10 ml between two injection sites. A sterile 17-gauge ½ inch (15-20 mm) needle is recommended. Replace with a fresh sterile needle after every 10-12 animals or sooner if the needle becomes soiled.
To ensure a correct dosage, bodyweight should be determined as accurately as possible. The use of suitably calibrated measuring equipment is recommended.
When the temperature of the product is below 5 °C, difficulty in administration may be encountered due to increased viscosity. Warming the veterinary medicinal product and injection equipment to about 15 °C will greatly increase the ease with which the veterinary medicinal product can be injected. Different injection sites should be used for other parenteral products administered concurrently.
When using the 200 ml, 500 ml and 1000 ml pack sizes, use only automatic syringe equipment. For the 50 ml pack sizes, use of a multidose syringe is recommended.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
The administration of 25 ml of the veterinary medicinal product per 50 kg bodyweight (25x the recommended dose level) resulted in an injection site lesion (including tissue necrosis, oedema, fibrosis and inflammation). No other drug-related adverse reactions could be determined.
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 cows including pregnant heifers within 60 days of calving.