Uses

For the treatment of gastro-intestinal nematodes, lungworms, warbles, chorioptic and sarcoptic mange mites and sucking and biting lice in cattle. The following parasites are treated:

Gastro-intestinal worms

(adult and fourth-stage larvae)

Haemonchus placei

Ostertagia ostertagi (including inhibited larvae)

Trichostrongylus axei

Trichostrongylus colubriformis

Cooperia punctata (adult only)

Cooperia oncophora (adult only)

Strongyloides papillosus (adult only)

Oesophagostomum radiatum

Lungworm

(adult and fourth-stage larvae)

Dictyocaulus viviparus

Warbles (parasitic stages)

Hypoderma bovis

Hypoderma lineatum

Mange mites

Sarcoptes scabiei var. bovis

The product may also be used to reduce infection of the mange mite Chorioptes bovis, but complete elimination may not occur.

Lice

Linognathus vituli

Haematopinus eurysternus

Bovicola (Damalinia) bovis

Qualimec Cattle Pour-On has persistent activity against infections acquired with Trichostrongylus axei and Cooperia spp. up to 14 days after treatment, but only in the case of group treatment; Ostertagia ostertagi and Oesophagostomum radiatum up to 21 days after treatment; Dictyocaulus viviparus up to 28 days after treatment. It also has persistent activity against horn flies (Haematobia irritans) for up to 28 days after treatment; partial efficacy against Haematobia irritans may last for up to 35 days post application.

Dosage and administration

Assess bodyweight as accurately as possible before calculating the dosage.

1ml per 10kg body weight (based on a recommended dosage level of 500 micrograms per kg body weight).

Administration and Duration of Treatment

For topical (pour-on) application. The formulation should be applied along the mid-line of the back in a narrow strip between the wither and tailhead. Close container after use.

The 250 ml and 1.0 litre packs must be used with appropriate dosing equipment.

Instructions for using the dispensing chamber:

a) Take dip tube and insert end into base of measuring cap with slotted end going to the bottom of the container.

b) Remove shipping cap from container.

c)Screw measuring cap onto container.

d) Select the correct dose rate by rotating the adjuster cap in either direction to position the dose indicator to the appropriate dose.

e) Gently squeeze the bottle to fill to level (any excess will return to the bottle) and then tip and apply to animal along backline.

Contra-indications, warnings, etc

Contra-indications

Do not use in cases of known hypersensitivity to the active ingredient.

Warnings, precautions

Do not treat cattle when their hide is wet. Do not treat cattle if rain is expected, as rain within 2 hours of treatment may reduce efficacy. Do not apply to areas of skin which have mange scabs or other lesions or to areas contaminated with mud or manure.

To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine, it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites.

The product has been formulated for topical application specifically for cattle. It should not be administered to other species as severe adverse reactions may occur. Cases of intolerance with fatal outcome are reported in dogs, especially Collies, old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises. Do not allow these species to come in contact with this product.

It is recommended to treat all animals within a herd or group.

The shedding of nematode eggs can continue for some time after treatment.

Frequent and repeated use may lead to the development of resistance. It is important that the correct dose is given in order to minimise the risk of resistance. To avoid under dosing animals should be grouped according to their body weight and dosed according to the heaviest animal in the group.

Can be used during pregnancy and lactation provided that the milk is not intended for human consumption.

Do not combine ivermectin treatment with vaccination against lungworms. If vaccinated animals are to be treated, treatment should not be carried out within a period of 28 days before or after vaccination.

Withdrawal periods

Meat and offal: 31 days.

Milk: Not permitted for use in lactating cattle producing milk for human consumption. Do not use in non-lactating dairy cows, including pregnant dairy heifers, within 60 days of calving.

Operator warnings

May be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons. Operators should wear rubber gloves, boots, goggles and a waterproof coat when applying the product. Protective clothing should be washed after use. As absorption through skin can occur, in the event of accidental skin contact, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and get medical attention. Do not smoke, eat or drink while handling the product. Wash hands after use. Use only in well ventilated areas or outdoors.

Highly inflammable, keep away from heat, sparks, open flame or other sources of ignition.

Adverse reactions

None known

Overdosage No signs of toxicity appeared in trials up to 3 times the recommended dose rate. Clinical symptoms of ivermectin toxicity include ataxia and depression. No antidote has been identified. In case of overdose, symptomatic treatment should be given.

Disposal

The product is extremely dangerous to fish and aquatic life. Do not contaminate surface water or ditches with product or the used container. Any unused product or waste material should be disposed of in accordance with national requirements.

For external treatment only. For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Do not store above 25°C. Protect from direct light. Store in tightly closed, original container.

If stored at temperatures below 0°C, the solution may appear cloudy. Allowing to warm at room temperature will restore normal appearance without affecting efficacy.

Legal category

POM-VPS

Packaging Quantities

250 ml, 1 litre, 2.5 litres and 5 litres plastic bottles.

Further information

Ivermectin belongs to the chemical group of anthelmintics coded 3-AV.

After administration of Qualimec Pour-On, the ivermectin is absorbed through the skin into the circulation of the treated animal. The maximum concentration in plasma occurs around 70 hours after application. Peak concentrations of about 7 ng/ml are obtained.

The residual antiparasitic effect of ivermectin is due to its persistence, which in turn is due in part to its long intrinsic half-life (t1/2β of approximately 210 hours), in part to its relatively high plasma protein binding (80% in cattle; binding remains relatively constant over time) and in part to the nature and type of the ivermectin formulation.

Elimination is in the faeces (via biliary excretion). Over 60% of the dose is excreted after 3 days.