1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

IVOMEC Classic Injection for Cattle and Sheep

(ivermectin)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Ivermectin 10 mg

For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Solution for injection.

A clear, pale, straw-coloured liquid

4.

CLINICAL PARTICULARS

4.1

Target species

Cattle and sheep.

4.2

Indications for use, specifying the target species

Indicated for the effective treatment and control of the following parasites of cattle and sheep:

CATTLE

Inhibited

PARASITE

Adult

L4

L4

Gastrointestinal Roundworms

Ostertagia lyrata

Ostertagia ostertagi

Cooperia oncophora

Cooperia pectinata

Cooperia punctata

Haemonchus placei

Trichostrongylus axei

Trichostrongylus colubriformis

Bunostomum phlebotomum

Oesophagostomum radiatum

Strongyloides papillosus

Nematodirus helvetianus

Nematodirus spathiger

Trichuris spp.

Lungworms

Dictyocaulus viviparus

Eye Worms

Thelazia spp

Warbles

Hypoderma bovis

H. lineatum

Mange Mites

Psoroptes ovis

Sarcoptes scabei var. bovis

Sucking Lice

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

The 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

Given at the recommended dosage of 1ml per 50kg bodyweight, the product

controls re-infection with the following nematodes up to the duration shown:

Parasite

No. of Days After

Treatment

Barbers pole worm - Haemonchus placei

14

Small intestinal worm - Cooperia spp.

14

Hairworm – Trichostrongylus axei

14

Brown stomach worm - Ostertagia ostertagi

21

Nodular worm - Oesophagostomum radiatum

21

Lungworm – Dictyocaulus viviparus

28

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.

SHEEP

Inhibited

PARASITE

Adult

L4

L4

Gastrointestinal Roundworms

Ostertagia circumcincta

O. trifurcata

Haemonchus contortus

Trichostrongylus axei

T. colubriformis

T. vitrinus

Cooperia curticei

Oesophagostomum columbianum

O. venulosum

Nematodirus filicollis

Chabertia ovina

Trichuris ovis

Lungworms

Dictyocaulus filaria

Protostrongylus rufescens

Nasal Bots

Oestrus ovis

Mange Mites

Psoroptes ovis*

Benzimidazole-resistant strains of Haemonchus contortus and Ostertagia circumcincta are also controlled.

4.3

Contra-indications

Do not inject intravenously or intramuscularly.

The product is specifically for use in the target species. Do not use in other species as severe adverse reactions, including fatalities in dogs, may occur.

4.4

Special warnings for each target species

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 (if any).

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 Teladorsagia spp. in sheep and 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

4.5

Special precautions for use

i. Special precautions for use in animals

When treating groups of animals use only an automatic dosing device (with vented draw off apparatus when using the 50ml vial).

Syringes must be filled from the vial through a dry sterile draw-off needle that has been placed in the vial stopper. Vial stoppers must not be broached more than 20 times.

Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. To ensure complete control great care must be taken to avoid re–infestation, as mites may be viable for up to 15 days off the sheep. It is important that all sheep which have been in contact with infected sheep are treated. Contact between treated, infected and untreated flocks must be avoided until at least seven days after treatment.

In sheep, treatment of psoroptic mange (sheep scab) with one injection is not recommended because, although clinical improvement may be seen, elimination of all mites may not occur.

This product does not contain any antimicrobial preservative.

Swab septum before removing each dose. Use a sterile needle and syringe.

ii. Special precautions to be taken by the person administering the medicinal product to the animals

Do not smoke, drink or eat while handling the product.

Wash hands after use.

Take care to avoid self-injection: the product may cause local irritation and/or pain at the site of injection.

In case of accidental self-injection, seek medical advice and show the label or package leaflet to the physician.

4.6

Adverse reactions (frequency and seriousness)

Cattle

Mild and transient discomfort has occasionally been observed in cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed.

Sheep

Discomfort, sometimes intense but usually transient, has been observed in some sheep following subcutaneous administration.

In both species these reactions disappear without treatment.

4.7

Use during pregnancy, lactation or lay

IVOMEC Classic Injection for Cattle and Sheep can be administered to cows and ewes at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. It can be used in breeding ewes, rams, bulls and cows without affecting fertility. IVOMEC Classic Injection can be given to all ages of animals including young calves and lambs.

4.8

Interaction with other medicinal products and other forms of interaction

IVOMEC Classic Injection for Cattle and Sheep has been used concurrently without adverse effects with foot and mouth disease vaccine or clostridial vaccine, given at separate injection sites.

Adequate vaccination of sheep against clostridial infections is strongly recommended.

4.9

Amounts to be administered and administration route

IVOMEC Classic Injection for Cattle and Sheep should be given only by

subcutaneous injection, using aseptic precautions, at the recommended dosage level of 200 mcg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle and in the neck in sheep.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Use this chart as a guide in working out the appropriate dose rate:

CATTLE

(1ml/50kg)

SHEEP

(0.5ml/25kg)

Bodyweight (kg)

Dose Volume (ml)

Bodyweight (kg)

Dose Volume (ml)

Up to 50

51 – 100

101 – 150

151 – 200

201 – 250

251 – 300

301 – 350

351 – 400

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

Up to 5

5.1 – 10

10.1 – 15

15.1 – 25

25.1 – 50

50.1 – 75

75.1 - 100

0.1

0.2

0.3

0.5

1.0

1.5

2.0

For cattle weighing over 400kg calculate the dose at the rate of 1ml per 50kg bodyweight

For sheep weighing over 100kg calculate the dose at the rate of 0.5ml per 25kg.

When treating sheep of less than 16kg, seek veterinary advice regarding the use of 1ml disposable syringes graduated in increments of 0.1ml. For the treatment of individual sheep, a syringe not exceeding 2.0ml and calibrated in increments of 0.1ml should be used.

Each ml contains 10 mg of ivermectin sufficient to treat 50 kg of bodyweight of cattle and sheep. The injection may be given with any standard automatic or single-dose or hypodermic syringe. Use of a sterile 17 gauge x ½ inch needle is suggested. Replace with a fresh sterile needle after every 10 to 12 animals. Injection of wet or dirty animals is not recommended.

10 mg o For the treatment and control of sheep scab, two injections with a seven day interval are required to treat clinical signs of scab and to eliminate mites.

4.10

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

Cattle

Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

No antidote has been identified, however, symptomatic therapy may be beneficial.

Sheep

Dose levels up to 4 mg ivermectin per kg (20 x the use level), given subcutaneously, resulted in ataxia and depression.

4.11

Withdrawal periods

Cattle (meat & offal): 49 days

Cattle (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.

Sheep (meat & offal): 37 days

Sheep (milk): Do not use in sheep producing milk for human consumption.

5.

PHARMACOLOGICAL PROPERTIES

ATC Vet Code:

QP54AA01

5.1

Pharmacodynamic properties

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind 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 hyperpolarization 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-aminobutyric 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, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

5.2

Pharmacokinetic properties

Maximum plasma concentration

Cattle

At a dose level of 0.2 mg ivermectin per kg a maximum plasma concentration of 35-50 ng/ml is reached in about 2 days and the half-life in plasma is 2.8 days. It is also established that ivermectin is carried mainly in the plasma (80%). This distribution between plasma and blood cells remains relatively constant.

Sheep

At a dose level of 0.3 mg ivermectin per kg an average peak of 16 ng/ml is reached one day after injection.

Excretion: length of time and route

Cattle

A liquid chromatographic method with fluorescence detection allows the determination of ivermectin residues in tissues. After an injection of 0.3 mg

ivermectin per kg, the liver (target tissue) had residues ranging from 454 ppb at 2 days post treatment to 11 ppb at 28 days post treatment. All other tissues had lower residues at all time periods: fat > kidney > muscle.

The injection site had residues shortly after treatment, ranging up to 69 ppm at 2 days withdrawal, but by 28 days the average residue was negligible (< 2 ppb). Cattle receiving a single dose of tritium-labelled ivermectin (0.2 - 0.3 mg/kg bodyweight) were slaughtered at 7, 14, 21 and 28 days after dosing.

Composites of faeces collected during the first 7 days after dosing contained almost all the dosed radioactivity. Only about 1-2 % of the dosed radioactivity was excreted in the urine.

Analyses of the faeces showed that about 40-50% of the excreted radioactivity was present as unaltered drug. The remaining 50-60% was present as metabolites or degradation products almost all which were more polar than the ivermectin.

Sheep

A liquid chromatographic method with fluorescence detection allows the determination of ivermectin residues in tissues. After an injection of 0.3 mg

ivermectin per kg, the liver (target tissue) had residues ranging from 160 ppb at 3 days post treatment to 7.2 ppb at 28 days post treatment. The highest residue levels were recovered in fat (from 230 ppb at 3 days post treatment to 13 ppb at 28 days post treatment). Residues in all tissues were below 30 ppb at 28 days post treatment. Radioactive ivermectin was administered to sheep at a dose rate of 0.3 mg per kg. Analyses of the faeces showed that about 99% of the drug and its metabolites are excreted in the faeces, about 1 % being excreted in the urine.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Glycerol Formal

Propylene Glycol

6.2

Incompatibilities

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

6.3

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.

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

6.4

Special precautions for storage

Protect from direct sunlight.

Following withdrawal of the first dose, use the product within 6 months.

Discard unused material.

6.5

Nature and composition of immediate packaging

Multiple-dose rubber-capped polyethylene bottles of 50 ml, 200 ml, 500 ml and 1000ml. Bottles are closed with grey butyl rubber bungs and then crimp-sealed with an aluminium cap.

6.6

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

Container disposal:

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used container.

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7.

MARKETING AUTHORISATION HOLDER

Merial Animal Health Limited

PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex

CM19 5TG

8.

MARKETING AUTHORISATION NUMBER

Vm 08327/4188

9.

DATE OF FIRST AUTHORISATION

22 September 1997

10.

DATE OF REVISION OF THE TEXT

September 2016

11.

ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE

Not applicable.