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Date: Monday, April 29, 2024 1:19

Description: Ceva logo
Release 2.138
Regulin® 18 mg implant
 
Species: Sheep
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Others
Active ingredient: Melatonin
Product:Regulin® 18 mg implant
Product index: Regulin
Sheep - meat: Zero days
Withdrawal notes: Milk: Zero hours
Incorporating:
Qualitative and quantitative composition
mg per implant
Active ingredient:
Melatonin 18.00
Excipients:
Quinoline yellow lake (E104) 0.04
For a full list of excipients, see Pharmaceutical particulars.
Pharmaceutical form
Implant.
Yellow cylindrical implant.
Clinical particulars
Target species
Sheep (ewes)
Indications for use
To improve the reproductive performance of pure bred and cross bred lowland sheep which are to be mated early in the season before the usual peak of reproductive activity.
When used as directed, it stimulates the early onset of natural reproductive activity giving improved reproductive performance of flocks mated early in the season. The product is recommended for use in Suffolk and Suffolk-cross type flocks intended to start lambing between early December and mid-January and in the Mule and half-bred flocks starting lambing between late December and mid-February.
Contraindications
Only use in adult ewes and shearlings.
Do not use at times other than those recommended.
Use by subcutaneous implantation at the base of the ear only.
Not effective on sexually immature animals
Special warnings for each target species
Regulin only overcomes the effects of seasonality. If there are any other adverse influences on reproduction present within a flock, the full benefit of Regulin treatment may be reduced or even eliminated. Aspects of implantation related to animal welfare and more intensive husbandry practices should be discussed with your veterinary surgeon prior to use.
Special precautions for use, including special precautions to be taken by the person administering the medicinal product to animals
Special precautions for use in animals
Avoid damaging implants. Use only sharp undamaged needles. Needles should be from gamma irradiated packs only. Replace the needle after each batch of 25 sheep to overcome blunting.
Regulin will not synchronise oestrus.
Special precautions to be taken by the person administering the medicinal product to animals
Care should be taken to avoid accidental self-injection. In the case of accidental self-injection, seek medical advice immediately.
Adverse reactions (frequency and seriousness)
None
Use during pregnancy, lactation or lay
Use in ewes suckling lambs at foot may not give optimum results. The product will be safe to use in pregnant ewes but obviously will not be effective.
Interaction with other medicinal products and other forms of interaction
None known
Amounts to be administered and administration route
Dose: One implant per ewe by subcutaneous administration at the base of the ear.
Administration: Use the implanter to administer one implant near the base of the ear.
In Suffolk and Suffolk-cross types, the implant should be used from mid-May to late June for ram introduction in late June and July. In Mule and half-bred flocks it should be administered from early June to July for ram introduction from mid-July to late August.
Do not use at times other than those recommended. Do not administer if sheep are wet or dirty.
Treatment regime:
Day 1 (30 weeks before intended start of lambing).
As the presence of any ram (and also male goats) will interfere with the ovulatory process, isolate ewes from all males. The ewes should be out of sight, sound and smell. Separating males into the next field from females is not adequate.
Day 7:
Implant ewes at the base of the ear. Do not administer if sheep are wet or dirty. Ewes must remain isolated from male sheep and goats.
Day 42 (35 days after implantation):
The period between implanting and introduction of the males must be not less than 30 days and no more than 40 days. Introduce rams, but expect a delay of 14-21 days before mating activity commences. Vasectomised rams may be used for the first 14 days to ensure a more compact lambing period. The peak of mating activity will occur 25-35 days after introduction of the rams.
Overdose (Symptoms, emergency procedures, antidotes)
No special actions required. In any event, overdose is highly unlikely
Withdrawal periods
Meat: Zero days
Milk: Zero hours
Pharmacological particulars
Regulin® implants contain melatonin, a natural secretion of the pineal gland. Melatonin is the day length messenger by which all animals recognise different seasons. The pineal gland only produces melatonin during hours of darkness. As days shorten the amount of melatonin secreted increases and this signals the reproductive system to increase activity, producing a natural peak in breeding performance in the autumn. Regulin works by mimicking this effect: each implant slowly releases melatonin over an extended period.
Pharmaceutical particulars
List of excipients
Quinoline yellow aluminium lake (E104), Ethyl cellulose (E462), Vegetable oil hydrogenated, Dibutyl Phthalate
Major incompatibilities
None known
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years
Special precautions for storage
The product is sterile. Only open each blister section when required. To maintain sterility, opened product must be discarded at the end of the working day.
Keep blister trays in outer carton.
Nature and contents of container
25 yellow cylindrical implants are contained in separate wells of a polythene cartridge, designed to fit a manually operated implanter gun. Cartridges are housed in preformed UPVC blister trays sealed with foil.
Two blister trays (50 implants) are surrounded by a cardboard carton.
Special precautions for the disposal of unused medicinal product or waste materials if any
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 15052/4011
Significant changes
Date of the first authorisation or date of renewal
Date: 1st January 1993
Date of revision of the text
October 2022
Any other information
Nil
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Regulin 2x25 implants
GTIN:03411110042236