Qualimec Cattle Pour-on

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Ivermectin
Available from:
Eco Animal Health Limited
ATC code:
QP54AA01
INN (International Name):
Ivermectin
Dosage:
5 milligram(s)/millilitre
Pharmaceutical form:
Pour-on solution
Prescription type:
LM: Licensed Merchant as defined in relevant national legislation
Therapeutic group:
Cattle
Therapeutic area:
ivermectin
Therapeutic indications:
Endectoparasiticides
Authorization status:
Authorised
Authorization number:
VPA10859/009/001
Authorization date:
2001-05-17

Read the complete document

Health Products Regulatory Authority

04 February 2019

CRN008P22

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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Qualimec Cattle Pour-on

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml Pour-on solution contains:

Active substance(s):

Ivermectin 5 mg

Excipient(s):

Benzyl alcohol (E1519) 10 mg

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Pour-on solution.

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle.

4.2 Indications for use, specifying the target species

In cattle: For the treatment of infections with the following parasites:

Gastro-intestinal worms (adult and fourth stage larvae):

Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), Trichostrongylus

axei, Trichostrongylus colubriformis, Cooperia spp., Strongyloides papillosus (adult),

Oesophagostomum radiatum, Trichuris spp. (adult)

Lungworm (adult and fourth stage larvae):

Dictyocaulus viviparus

Eye worms (adults):

Thelazia spp.

Warbles (parasitic stages):

Hypoderma bovis and H. lineatum.

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Mange mites:

Sarcoptes scabiei var. bovis and Chorioptes bovis

Sucking lice:

Linognathus vituli and Haematopinus eurysternus.

Biting louse:

Damalinia bovis

Given at the dosage of 500 micrograms per kg bodyweight, Qualimec Cattle Pour-on

controls infections acquired with Trichostrongylusaxei and Cooperiaspp. up to 14 days

after treatment, but only in case of group treatment; Ostertagiaostertagi and

Oesophagostomumradiatum up to 21 days after treatment; Dictyocaulusviviparous up

to 28 days after treatment.

Occasionally variable activity may be observed against Haemonchus placei (L4),

Cooperia spp., Trichostrongylus axei, Trichostrongylus colubriformis.

Qualimec Cattle Pour-on also controls horn fly (Haematobia irritans) for 28 days,

partial efficacy may last for up to 35 days post application.

Studies have demonstrated that first-season grazing calves turned out to pasture in

late April or May and treated 3, 8 and 13 weeks after turn-out can be protected from

parasitic gastro-enteritis and lungworm disease throughout the grazing season,

provided they are set stocked, all the calves are included in the programme and that

no untreated cattle are added to the pasture. Treated calves should always be

monitored according to good husbandry practices.

4.3 Contraindications

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

Do not use in lactating dairy cows producing milk for human consumption. Do not

use in non-lactating dairy cows, including pregnant dairy heifers, within 60 days of

calving.

4.4 Special warnings for each target species

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.

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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.

4.5 Special precautions for use

Special precautions for use in animals

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.

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.

Close container after use.

Special precautions to be taken by the person administering the veterinary

medicinal product to animals

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.

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4.6 Adverse reactions (frequency and seriousness)

None known

4.7 Use during pregnancy, lactation or lay

Studies in laboratory animals have shown neither embryotoxic nor teratogenic effects

with ivermectin.

Can be used during pregnancy and lactation provided that the milk is not intended

for human consumption.

Please also see section 4.3.

4.8 Interaction with other medicinal products and other forms of interactions

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.

4.9 Amounts to be administered and administration route

Bodyweight should be assessed as accurately as possible before calculating the

dosage.

Dosage

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

micrograms per kg body weight).

Administration

For topical application.

The formulation should be applied along the mid-line of the back in a narrow strip

between the withers and tailhead.

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.Gently squeeze the bottle to fill

to level (any excess will return to the bottle) and then tip and apply to animal along

backline.

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4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal period(s)

Meat and offal: 28 days. Do not 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.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Ivermectin is a mixture of two compounds belonging to the avermectin family, which

are a macrocyclic lactone group of endectocides. Avermectin is a microbial

metabolite of the soil organism Streptomyces avermilitis.

ATC vet code: QP54AA01.Therapeutic group: endectocide.

5.1 Pharmacodynamic properties

It is generally accepted that ivermectin exerts its action in two main ways,

interference with neurotransmission and opening chloride ion channels. The effect of

ivermectin on the parasitic CNS is considered to operate through

glutamate-mediated chloride channels. Compounds of this class may also interact

with other ligand-gated chloride channels, such as those gated by the

neurotransmitter gamma-aminobutyric acid (GABA).The opening of pre-synaptic

chloride ion channels results in an efflux of chloride ions and depolarisation of the

nerve terminal. These effects interfere with normal neurotransmission between

nerves and muscles, resulting in parasite paralysis and eventual death.

5.2 Pharmacokinetic particulars

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 (t

1/2β

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

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formulation.Elimination is in the faeces (via biliary excretion). Over 60% of the dose is

excreted after 3 days.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Isopropyl alcohol

Polypropoxylate-2-myristyl ether propionate

N-methyl-2-pyrrolidone

Benzyl Alcohol (E1519)Water

6.2 Major incompatibilities

None known.

6.3 Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

Shelf-life after first opening the immediate packaging: 6 months

6.4 Special precautions for storage

Protect from direct light.Store in tightly closed, original container.

6.5 Nature and composition of immediate packaging

250 ml white non-fluorinated or fluorinated high-density polyethylene bottle with a

drawing tube and measuring device.

1.0 L white non-fluorinated or fluorinated high-density polyethylene bottle with a

drawing tube and measuring device.

2.5 L white non-fluorinated or fluorinated high-density polyethylene back-pack with

polypropylene strap and vented cap

5.0 L white non-fluorinated or fluorinated high-density polyethylene back-pack with

polypropylene strap and vented cap.

Closure: White polypropylene screw-cap.

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6.6 Special precautions for the disposal of unused veterinary medicinal

products or waste materials derived from the use of such products

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.

7 MARKETING AUTHORISATION HOLDER

Eco Animal Health Limited

78 Coombe Road

New Malden

Surrey

KT3 4QS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA10859/009/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 17 May 2001

Date of last renewal: 02 August 2006

10 DATE OF REVISION OF THE TEXT

February 2019

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