SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ivomec Classic Injection for Cattle and Sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance: Ivermectin 10 mg Excipients:

Qualitative composition of excipients and other constituents

Glycerol formal

Propylene glycol

A clear, pale, straw-coloured liquid.

3. CLINICAL INFORMATION

3.1 Target species

Cattle and sheep.

3.2 Indications for use for each target species

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

Cattle

			Inhibited
PARASITE Gastrointestinal roundworms:	Adult	L4	L4
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 veterinary medicinal 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.

Persistant activity

Given at the recommended dosage of 1ml per 50 kg bodyweight, the veterinary medicinal 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 Gastrointestinal roundworms:	Adult	L4	L4
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.

3.3 Contraindications

The veterinary medicinal product is not for intramuscular or intravenous use. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

3.4 Special warnings

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

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.

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.

3.5 Special precautions for use

Special precautions for safe use in the target species:

The veterinary medicinal product has been formulated specifically for use in the target species. It should not be used in other species as severe adverse reactions, including fatalities in dogs, may occur.

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.

This product does not contain any antimicrobial preservative.

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

Special precautions to be taken by the person administering the veterinary medicinal product to the animals:

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

Wash hands after use.

Take care to avoid self-injection as the veterinary medicinal product may cause local irritation and/or pain at the site of injection. In case of accidental selfinjection, seek medical advice and show the label or package leaflet to the physician.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

Cattle:

Rare (1 to 10 animals / 10,000 animals treated):	Injection site swelling (soft tissue)1
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Discomfort2

¹ disappears without treatment

² transient after subcutaneous administrationSheep:

Very rare: (<1 animal / 10,000 animals treated, including isolated reports):

Pain1

¹ sometimes intense but usually transient; disappears without treatment

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

The veterinary medicinal product can be administered to beef cows and ewes at any stage of pregnancy or lactation provided that the milk is not intended for human consumption.

The veterinary medicinal product will not affect the fertility of cows, bulls, breeding ewes and rams and can be given to all ages of animals including young calves and lambs.

3.8 Interaction with other medicinal products and other forms of interaction

The veterinary medicinal product 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.

3.9 Administration routes and dosage

The veterinary medicinal product 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 SHEEP

(1 ml/50 kg) (0.5 ml/25 kg)

Bodyweight Dose Volume (ml) Bodyweight (kg) Dose Volume (ml)

(kg)

Up to 50 1.0 Up to 5 0.1

51 – 100 2.0 5.1 – 10 0.2

101 – 150 3.0 10.1 – 15 0.3

151 – 200 4.0 15.1 – 25 0.5

201 – 250 5.0 25.1 – 50 1.0

251 – 300 6.0 50.1 – 75 1.5

301 – 350 7.0 75.1 - 100 2.0

351 – 400 8.0

For cattle weighing over 400 kg For sheep weighing over 100 kg calculate calculate the dose at the rate of 1 ml the dose at the rate of 0.5 ml per 25 kg. per 50 kg bodyweight

When treating sheep of less than 16 kg, seek veterinary advice regarding the use of 1 ml disposable syringes graduated in increments of 0.1ml. For the treatment of individual sheep, a syringe not exceeding 2 ml and calibrated in increments of 0.1 ml 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. If using a single-dose or hypodermic syringe, use a separate sterile needle to withdraw the veterinary medicinal product from the pack.

For the treatment and control of sheep scab (Psoroptes ovis), two injections with a seven-day interval are required to treat clinical signs of scab and to eliminate mites.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Cattle

Single doses of 4 mg ivermectin per kg (20x the recommended use level) given subcutaneously resulted in ataxia and depression.

Sheep

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

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

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Cattle (meat & offal): 49 days.

Cattle (milk): Do not use in lactating cows 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 lactating sheep producing milk for human consumption.

4. PHARMACOLOGICAL INFORMATION

4.1 ATC Vet Code: QP54AA01

4.2 Pharmacodynamics

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 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-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.

4.3 Pharmacokinetics

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.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

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

5.2 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.

5.3 Special precautions for storage

Store below 30 °C.

Protect from direct sunlight.

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

5.4 Nature and composition of immediate packaging

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

Not all pack sizes may be marketed.

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

Medicines should not be disposed of via wastewater.

The veterinary medical product should not enter water courses as ivermectin may be dangerous for fish and other aquatic organisms.

Do not contaminate surface waters or ditches with product or used container.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste material derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH

7. MARKETING AUTHORISATION NUMBERS

Vm 61700/5002

Vm 61700/3002

8. DATE OF FIRST AUTHORISATION

22 September 1997

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 01 December 2025