Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@jacgb.jnj.com

Presentation

A clear pour-on solution containing 5 milligrams ivermectin per millilitre.

Uses

For the treatment and control of gastro-intestinal nematodes, lungworms, warbles, chorioptic and sarcoptic mange, horn flies and sucking and biting lice of beef and non-lactating dairy cattle. Qualimintic pour-on for cattle effectively controls the following parasites:

Cattle

Gastro-intestinal nematodes

(adult and fourth-stage larvae)

Ostertagia ostertagi (including inhibited larvae)

Haemonchus placei

Trichostrongylus axei

Trichostrongylus colubriformis

Cooperia spp

Oesophagostomum radiatum

Strongyloides papillosus (adult)

Trichuris spp (adult)

Lungworm

(adult and fourth-stage larvae)

Dictyocaulus viviparus

Warbles (parasitic stages)

Hypoderma bovis

Hypoderma lineatum

Mange mite

Sarcoptes scabiei var. bovis

Chorioptes bovis

Lice

Linognathus vituli

Haematopinus eurysternus

Damalilia (Bovicola) bovis

Solenopotes capillatus

Horn flies

Haematobia irritans

Dosage and administration

The recommended dose is 500 micrograms ivermectin per kg bodyweight. This corresponds to 1 ml per 10 kg bodyweight.

Bodyweight (kg)	Dose volume (ml)
100	10
150	15
200	20
250	25
300	30
Over 300 kg bodyweight, give 1 ml per 10 kg bodyweight.

Administration and Duration of Treatment

A single, topical (pour-on) administration. The solution should be applied along the mid-line of the back in a narrow strip between the wither and tailhead.

Contra-indications, warnings, etc

Contra-indications

Qualimintic pour-on for cattle has been formulated for topical application specifically in cattle. It should not be applied or administered to other species, as severe adverse reactions, including fatalities in dogs – in particular, collies and bobtails – and turtles may occur.

Do not use in animals weighing 50kg bodyweight or less.

Warnings, precautions

Do not treat cattle when their hide or hair 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.

Do not combine with lungworm inoculations. If applying to animals which have been inoculated or are to be inoculated, do not apply within 28 days before/after inoculation.

Qualimintic pour-on for cattle can be administered to beef cows at any stage of the pregnancy or lactation, provided that the milk is not intended for human consumption. Qualimintic pour-on for cattle will not affect the fertility of cows and bulls and can be given to all ages of animals including young calves. Do not use in non-lactating dairy cows including pregnant heifers within 60 days prior to calving.

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

Withdrawal periods

Meat: Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 28 days from the last treatment.

Milk: Not for use in animals producing milk for human consumption.

Operator warnings

Qualimintic pour-on for cattle is a highly flammable solution.

Qualimintic pour-on for cattle 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 nitrile rubber gloves and boots with a waterproof coat when applying the product. Protective clothing should be washed after use. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and obtain medical attention.

Keep away from heat, sparks and open flame or other sources of ignition.

Do not smoke or eat while handling the product. Wash hands after use. Use only in well ventilated areas or outdoors.

Side-effects

Occasionally, irritation at the application site may occur which disappears without treatment.

Overdosage

No toxicity was observed up to 5 mg/kg bodyweight (10 times the recommended dose). No antidote is known.

Pharmaceutical precautions

Store away from heat and protect from light. When not in use, store product in tightly closed upright, original container inside the outer carton. If stored below 0 °C, Qualimintic pour-on for cattle may appear cloudy. Allowing to warm at room temperature will restore the normal appearance without affecting efficacy.

Legal category

POM-VPS

Packaging Quantities

250 ml, 1 litre bottles with dosing system and 2.5 litres backpack.

Further information

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

Marketing authorisation number

VM 19450/4000.