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Lutalyse

Item no: LUTALYSE
 
Prescription Medicine
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  • 30ml
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£53.55
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Gonavet Veyx 50 micrograms/ml solution for injection for cattle, pigs and horses.

Target Species
Cattle (cows, heifers), pigs (sows, gilts), horses (mares)

Indications for use, specifying the target species
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

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 case of known hypersensitivity to the active substance or to any of the excipients.

Special warnings for each target species
To maximise conception rates of cows to be treated with GnRH-PGF2 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.

Special precautions for use

Special precautions for use in animals
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 selfinjection, 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 childbearing potential should administer the product with caution. People with known hypersensitivity to GnRH should not use this veterinary medicinal product.

Adverse reactions (frequency and seriousness)
None known.

Use during pregnancy, lactation or lay
Pregnancy
Not applicable.

Lactation
Can be used during lactation.

nteraction with other medicinal products and other forms of interaction
A synergistic effect occurs in case of combined administration with FSH. Simultaneous use of human or equine
chorionic gonadotropin may lead to ovarian over-stimulation.

Amounts to be administered and administration route
For intramuscular or subcutaneous injection. For intramuscular use, preferably in the neck region. The product is intended for single administration except when used as part of the Ovsynch timed artificial insemination protocol.
Dosage in ml product and micrograms Gonadorelin[6-D-Phe] per animal.

Cattle (cows and heifers) by intramuscular injection: 1.0 - 2.0 ml
(corresponding to 50 100 micrograms of Gonadorelin[6-D-Phe])
- 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 ml
(corresponding to 25 75 micrograms of Gonadorelin[6-D-Phe])
- 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 micrograms of Gonadorelin[6-D-Phe])
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 Ovsynchprocedure was developed, which consists of the combined use of GnRH and PGF2. The following timed AI protocol has been commonly reported in the literature:
The Ovsynch-procedure may not be as efficacious in heifers as in cows.
Day 0: Inject 100 micrograms of Gonadorelin[6-D-Phe]per
animal
(2 ml of the product)
Day 7: Inject PGF2 or analogue (luteolytic dose)
Day 9: Inject 100 micrograms of Gonadorelin[6-D-Phe]per
animal
(2 ml of the product)
AI: 16 20 hours later, or at observed oestrus if sooner

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 Gonavet Veyx in gilts is 50 micrograms Gonadorelin[6-D-Phe]. However, the dose may be adjusted within the range of 50 - 75 micrograms to take into account farm-specific aspects or seasonal influences. The proposed time table should be strictly kept.
** The preferred dose of Gonavet Veyx in adult sows is 50 micrograms Gonadorelin[6-D-Phe]. However, the administration of 25 micrograms 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.

Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.

Withdrawal Period(s)
Cattle, pigs, horses Meat and offal: Zero days
Cattle, horses Milk: Zero hours

PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Systemic hormonal preparations, excl. sex hormone and insulin.
ATCvet code: QH01CA01 (Gonadorelin)
Gilts* Adult sows**
Induction of oestrus Peforelin 48 h or PMSG (eCG)
24 h - 48 h after last application of
Altrenogest
Peforelin or PMSG application 24 h
after weaning
Synchronization of
ovulation
Gonadorelin[6-D-Phe]78 - 80 h
after Peforelin or PMSG application
Suckling period > 4 weeks:
Gonadorelin[6-D-Phe]56 - 58 h
after Peforelin or PMSG application
Suckling period 4 weeks:
Gonadorelin[6-D-Phe]72 h after
Peforelin or PMSG application
Suckling period 3 weeks:
Gonadorelin[6-D-Phe]78 - 80 h
after Peforelin or PMSG application
1st AI 24 - 26 h after Gonadorelin[6-DPhe]application
24 - 26 h after Gonadorelin[6-DPhe]application
2nd AI 40 - 42 h after Gonadorelin[6-DPhe]application
40 - 42 h after Gonadorelin[6-DPhe]application

Pharmacodynamic properties
Gonadorelin[6-D-Phe] 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 andinduces ovulation in the female organism.
Gonadorelin[6-D-Phe] 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.

Pharmacokinetic properties
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.
Gonadorelin[6-D-Phe] 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 ahigher resistance against the catabolising enzymes.

PHARMACEUTICAL PARTICULARS
List of excipients
Chlorocresol
Sodium hydroxide (for pH adjustment)
Acetic acid, glacial (for pH adjustment)
Water for injections

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

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

Special precautions for 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.

Nature and composition of immediate packaging
Vial of colourless glass, type I, with a fluorinated bromobutyl 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.

Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be
disposed of in accordance with local requirements.

Shipping charges mainland GB zone1

Value Weight Delivery Charge
Over £49.00 Any Weight FREE
Under £49.00 No weight limit £4.50
Under £49.00 Under 250 grams £3.49

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*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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