Regulin 18 mg Implant

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Melatonin

Available from:

Ceva Animal Health Ltd

INN (International Name):

Melatonin

Pharmaceutical form:

Implant

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Sheep

Therapeutic area:

Hormone

Authorization status:

Authorized

Authorization date:

1993-01-01

Summary of Product characteristics

Revised: October 2022
AN: 01596/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Regulin
®
18 mg implant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
mg per implant
Active ingredient:
Melatonin
18.00
Other ingredients:
Quinoline yellow lake (E104)
0.04
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Implant.
Yellow cylindrical implant.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep (ewes)
4.2
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.
4.3
CONTRA-INDICATIONS
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
Revised: October 2022
AN: 01596/2022
Page 2 of 5
4.4
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.
4.5
SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE
TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
i.
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 bat