Ovimel 18 mg Implantation Tablets for Sheep

Composition

Each tablet contains:

Active substance:

Melatonin 18.00 mg

Excipients:

Film-coated implantation tablets yellowish to ochre colour

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Pharmacological properties

4.1 ATCvet code:

ATC vet code: QN05CH01.

4.2 Pharmacodynamics

Melatonin, the active substance of this veterinary medicinal product, is a hormone naturally secreted by the anterior pituitary gland. Melatonin signals photoperiodic change to the body, ie. variations in the day length throughout the year. Its secretion takes place during the night hours of darkness.

As day length decreases, melatonin secretion increases and triggers increased reproductive activity, thus producing a natural peak in breeding performance in the autumn.

This veterinary medicinal product simulates the phenomenon; each implantation tablet gradually releases melatonin for 3 to 4 months at rates comparable to those observed during the endogenous nocturnal secretion phase.

4.3 Pharmacokinetics

Melatonin shows good absorption after subcutaneous administration. The absolute bioavailability of melatonin released by the implant is 81% based on published results in sheep (ewes).

Fourteen days after the placement of the implant, the plasma concentrations are stable and higher than the standard diurnal levels, remaining up to three months.

Melatonin is metabolized in the liver to form 6-hydroxymelatonin that is conjugated with sulfate or glucuronic acid and excreted almost exclusively by urine.

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Target species

Sheep (sexually mature ewes)

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Indications

To improve reproductive performance in sheep intended to be mated early in the season, before the usual peak in reproductive activity.

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Dosage

Subcutaneous use

Dose: One implant per sexually mature ewe.

Administer at the base of the ear using the special gun provided. Introduce the needle in the subcutaneous area at the base of the ear. Press the trigger of the gun to release an implant. When the trigger is released, the gun automatically reloads.

Do not administer if sheep are wet or dirty.

The timing of implant application must be adapted to the photoperiod of the region and the seasonality of the animals, depending upon the breeds and production systems.

SHEEP (sexually mature ewe): Treatment regime without synchronization and with natural mating.

- Day 1 (30 weeks prior to intended lambing date):

- Isolate females from all males, if they are not normally separated.

- Day 7:

- Administer a subcutaneous implant at the base of the female's ear (with the special gun).

- Day 37-47 (between 30-40 days after implant administration):

- Introduce de rams. Sexual activity may not start immediately. A delay of 14 to 21 days should be expected before mating activity commences. Vasectomised rams may be used for the first 14 days for a more compact lambing period. Vasectomised males may be used for the first 14 days to allows lambing concentration. Maximum sexual activity occurs between 25 and 35 days after the introduction of the males.

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Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

None known.

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

The veterinary medicinal product is sterile. Carefully tear along the perforations to open each part of the blister when needed.

Avoid damaging implants. Use only sharp, undamaged needles.

Respect the usual conditions of hygiene during implantation.

Unless single-use needles are used for the administration of the implant, there is a risk of transmission of infectious diseases between treated animals.

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

Administer the veterinary medicinal product with caution to avoid accidental self- injection. In case of accidental self-injection, seek medical advice immediately, and show the package leaflet or the label to the physician.

Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.

Special precautions for the protection of the environment:

Not applicable.

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

None

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Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation, although it will not give optimal results as this veterinary medicinal product is not intended for use during pregnancy or lactation.

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Interactions

None known.

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Overdose

Overdose is highly unlikely given the characteristics of the drug and its route of administration. No special actions required.

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Special warnings

- This veterinary medicinal product will not synchronise oestrus.

- This veterinary medicinal product should only be used in sexually mature ewes (having lambed at least once).

- The reproductive performance in females treated with this veterinary medicinal product to advance the breeding season, is not superior to that obtained in the natural reproductive season.

- This veterinary medicinal product is intended only to overcome the effects of seasonality on the reproductive cycle. In the presence of other reproductive problems associated with pathological processes (abortions, mastitis), poor sanitary conditions, nutritional imbalances or any other cause, it is not advisable to use this veterinary medicinal product and veterinary advice should be sought.

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Withdrawal period

Meat and offal: Zero days

Milk: Zero hours

It is essential that the veterinary medicinal product is only administered subcutaneously at the base of ear.

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Incompatibilities

Not applicable.

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Immediate packaging

One box with 2 PVC/Alu Blisters containing one low-density polyethylene multi-shot tag cartridge with 25 implantation tablets each.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months.

Shelf life after first opening the immediate packaging: use immediately.

The remaining implantation tablets must be discarded after first opening the cartridge.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

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

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Additional information

Vm 32509/5007 (GB) Vm 32509/3007 (NI)

8 DATE OF FIRST AUTHORISATION

30 April 2025

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

April 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription Find more product information by searching for the ‘Product Information Database’ on www.gov.uk

Approved: 13 June 2025

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Registration holder

VETPHARMA ANIMAL HEALTH, S.L

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