Gonavet Veyx 50 µg/ml Solution for Injection for Cattle, Pigs and Horses

Composition

Each ml contains:

Active substance:

Federelin 50.0 µg

(equivalent to 52.4 µg Federelin acetate)

Excipients:

Chlorocresol 1.0 mg

Sodium hydroxide (for pH adjustment)

Acetic acid, glacial (for pH adjustment)

Water for injections

Clear, colourless solution.

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Pharmacological properties

4.1 ATCvet code: QH01CA01

4.2 Pharmacodynamics

Federelin is an agonist of the natural gonadotropin releasing hormone (GnRH) formed in the hypothalamus that is excreted in a pulsatile manner into the pituitary portal vein circulation and controls the synthesis of the follicle stimulating hormone (FSH) and luteinising hormone (LH) in the gonadotropic cells of the anterior pituitary gland as well as LH secretion. The pulse frequency and amplitude of the GnRH excretion are dependent on the stage of the cycle. Along with FSH, LH stimulates the release of estrogens from maturing follicles in the ovaries and induces ovulation in the female organism.

Federelin acetate has the same effect as endogenous GnRH: the LH peak in the spontaneous cycle is imitated and causes follicular maturation and ovulation or stimulates a new follicle maturation wave.

With high dosage repeated or continuous application of an agonist, the gonadotropic cells in the pituitary become temporarily refractory.

4.3 Pharmacokinetics

Following parenteral administration, GnRH and its analogues are absorbed rapidly and are distributed and eliminated from the organism following one-compartment- model kinetics. The plasma half-life is a few minutes (natural GnRH) up to 2 hours. The biological half-life of the natural, as well as the synthetic agonists, is short. Break-down occurs by enzymes in the form of peptidases and the excretion is primarily renal. The degradation products have no hormonal activity.

Federelin is a linear decapeptide that can only be differentiated using the difference in the amino acid at position 6 of GnRH: instead of glycine in GnRH the agonist contains D-phenylalanine. This modification leads to a higher resistance against the catabolising enzymes.

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Target species

Cattle (cows, heifers), pigs (sows, gilts), horses (mares).

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Indications

Control and stimulation of reproduction in cattle and pigs. Treatment of ovarian- related fertility disorders or dysfunctions in cattle and horses.

Cattle (cows, heifers):

- Ovulation induction in case of delayed ovulation due to LH-deficiency

- Induction/synchronization of ovulation within the framework of systems for timed inseminations

- Stimulation of the ovaries during the puerperal period from day 12 post partum

- Ovarian cysts (due to LH-deficiency)

Pigs (sows, gilts):

- Induction/synchronization of ovulation within the framework of systems for timed insemination and parturition synchronization

Horses (mares):

- Acyclia and anoestrus due to LH-deficiency

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Dosage

Intramuscular use, preferably in the neck region. Subcutaneous use.

The veterinary medicinal product is intended for single administration except when used as part of the “Ovsynch” timed artificial insemination protocol. Dosage in ml of the veterinary medicinal product and µg Federelin per animal.

Cattle (cows and heifers) by intramuscular injection: 1.0 - 2.0 ml (corresponding to 50 – 100 µg of Federelin)

- Ovulation induction in case of delayed ovulation due to LH-deficiency 2.0 ml

- Induction/synchronization of ovulation within the framework of systems for timed inseminations 1.0 - 2.0 ml

- Stimulation of the ovaries during the puerperal period from day 12 post partum 1.0 ml

- Ovarian cysts (due to LH-deficiency) 2.0 ml

Pigs (sows and gilts) by intramuscular or subcutaneous injection: 0.5 - 1.5 (corresponding to 25 – 75 µg of Federelin)

- Induction/synchronization of ovulation within the framework of systems for timed inseminations and parturition synchronization Sows: 0.5 - 1.0 ml Gilts: 1.0 - 1.5 ml

Horses (mares) by intramuscular injection: 2.0 ml (corresponding to 100 µg of Federelin)

The rubber stopper of the vial may be safely punctured up to 25 times. Otherwise, automatic syringe equipment, or a suitable draw-off needle, should be used for the 20 ml and 50 ml vials to avoid excessive puncturing of the closure.

Special information

Cattle:

For oestrus and ovulation synchronization and timed artificial insemination (AI) in cattle the so called “Ovsynch-procedure” was developed, which consists of the combined use of GnRH and PGF2α. The following timed AI protocol has been commonly reported in the literature:

Day 0: Inject 100 µg of Federelin per animal (2 ml of the product)

Day 7: Inject PGF2α or analogue (luteolytic dose)

Day 9: Inject 100 µg of Federelin per animal (2 ml of the product)

AI: 16 – 20 hours later, or at observed oestrus if sooner

The Ovsynch-procedure may not be as efficacious in heifers as in cows.

Pigs:

The ovulation synchronization system includes the administration of Peforelin or PMSG after the end of oestrus synchronisation with Altrenogest in gilts or after the weaning in adult sows and two timed artificial inseminations. In adult sows the time table depends on the duration of the suckling period. The following procedures are recommended:

* The preferred dose of the veterinary medicinal product in gilts is 50 µg Federelin. However, the dose may be adjusted within the range of 50 - 75 µg to take into account farm-specific aspects or seasonal influences. The proposed time table should be strictly kept.

** The preferred dose of the veterinary medicinal product in adult sows is 50 µg Federelin. However, the administration of 25 µg is also sufficient in case of sows with sow parity of more than 3 or during the mating period of September until May. The proposed time table should be strictly kept.

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Contraindications

Do not use in cows with a mature tertiary follicle ready to ovulate.

Do not use during infectious diseases and other relevant health disorders. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Cattle (cows, heifers), pigs (sows, gilts), horses (mares):

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:

Not applicable.

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

Administration should be performed with caution in order 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. As GnRH analogues can be absorbed through the skin, accidental spillage onto skin or into the eyes should be thoroughly rinsed off with water. The veterinary medicinal product should not be administered by pregnant women. Women of child-bearing potential should administer the product with caution. People with known hypersensitivity to GnRH should avoid contact with 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

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

Not applicable.

Lactation:

Can be used during lactation.

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Interactions

A synergistic effect occurs in case of combined administration with FSH, especially in case of a disturbed puerperal course. Simultaneous use of human or equine chorionic gonadotropin may lead to ovarian over-stimulation.

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Overdose

None known.

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Special warnings

To maximise conception rates of cows to be treated with GnRH-PGF2α based synchronization protocols, the ovarian status should be determined and regular cyclic ovarian activity confirmed. Optimal results will be achieved in healthy normally cycling cows.

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Withdrawal period

Cattle, pigs, horses:

Meat and offal: Zero days.

Cattle, horses:

Milk: Zero hours.

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Incompatibilities

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

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Immediate packaging

Vial of colourless glass, type I, with a fluorinated bromobutyl rubber stopper and an aluminium cap.

1 vial (10 ml) in a cardboard box.

1 vial (20 ml) in a cardboard box.

1 vial (50 ml) in a cardboard box.

Not all pack sizes may be marketed.

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Storage

Store in a refrigerator (2 °C - 8 °C).

Keep the vial in the outer carton in order to protect from light.

Do not store above 25 °C after opening.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 28 days.

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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 27569/4005

8 DATE OF FIRST AUTHORISATION

31 March 2015

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

May 2026

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: 10 June 2026

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Registration holder

Veyx-Pharma GmbH

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