A clear colourless to pale yellow sterile non-aqueous solution for injection.

Cattle

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)

Strongyloides papillosus (adult)

N. spathiger (adult)

N. helvetianus (adult)

Lungworms (adult and fourth-stage larvae)

Liver fluke (adult):

Eye worms (adult):

Warbles (parasitic stages):

Sarcoptes scabiei var. bovis

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.

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.

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.

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:

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.

This product does not contain any antimicrobial preservative. Swab septum before removing each dose.

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.

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.

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.

Can be used in pregnancy and lactation.

Can be used in breeding animals.

None known.

200μg ivermectin and 2mg clorsulon per kg bodyweight corresponding to a single dose of 1ml per 50kg bodyweight.

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.

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.

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.

Pharmacotherapeutic group: Endectocides, macrocyclic lactones, avermectins, ivermectin - combinations. ATC vet code: QP54AA51.

Ivermectin is a member of the macrocyclic lactone class of endectocides and has a unique mode of action. It has broad and potent antiparasitic activity. It binds selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarisation of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels such as those gated by the neurotransmitter gamma-amino-butyric acid (GABA).

The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, that the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

Clorsulon is rapidly absorbed in the blood stream and is bound to the erythrocytes and plasma which are ingested by the fluke. Clorsulon inhibits the glycolytic enzymes in the fluke and deprives it of its main source of metabolic energy.

After subcutaneous administration of 2mg clorsulon and 0.2mg ivermectin per kg bodyweight, the plasma profile demonstrated a slow, steady absorption of ivermectin which reached a maximum plasma concentration at a median time of 1.50 days. In contrast, clorsulon appeared rapidly absorbed with a maximum plasma concentration at a median time of 0.25 days. The terminal half life for the two active ingredients were determined as follows: Ivermectin approximately 3.79 days and clorsulon approximately 3.58 days.

Glycerol formal

Propylene glycol

Monoethanolamine (for pH adjustment)

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging: 28 days

Protect from light. Keep the container in the outer carton in order to protect from light.

Container material: High density polyethylene

Container closure: Siliconised grey bromobutyl rubber stopper with tamper evident aluminium overseal.

Container colour: Natural

Container volume: 50ml, 250ml or 500ml

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

19 February 2010

October 2018

Nil