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Date: Monday, July 6, 2020 1:14

Release 5.18
Acegon 50 μg/ml solution for injection for cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: GnRH products
Active ingredient: Gonadorelin
Product:Acegon® 50 micrograms/ml solution for injection for cattle
Product index: Acegon
Cattle - milk: Zero hours
Cattle - meat: Zero days
Presentation
Acegon is a solution for injection containing 50 micrograms/ml gonadorelin (as gonadorelin acetate). Also contains 9 mg/ml benzyl alcohol (E1519) as an excipient.
Uses
Indicated for the treatment of ovarian follicular cysts in cattle (cows and heifers) and in association with artificial insemination to optimise the time of ovulation.
Induction and synchronisation of oestrus and ovulation in combination with prostaglandin F (PGF) with or without progesterone as part of Fixed Time Artificial Insemination (FTAI) protocols:
- In cycling cows. To be used in combination with PGF or analogue.
- In cycling and non-cycling cows and heifers. To be used in combination with PGF or analogue and progesterone releasing device.
Dosage and administration
For intramuscular use.
Treatment of ovarian follicular cysts
100-150 micrograms of gonadorelin (as acetate) per animal (i.e. 2- 3 ml of the product per animal). If necessary, treatment can be repeated at intervals of 1-2 weeks.
In association with artificial insemination to optimise the time of ovulation, improving the chances that the treated cow will become fertile
100 micrograms of gonadorelin (as acetate) per animal (i.e. 2 ml of the product per animal). It must be administered at the same time as artificial insemination and/or 12 days after this.
The following timing of injection and insemination should be followed:
Injection should be performed between 4 and 10 hours after oestrus detection.
An interval of at least 2 hours between the injection of GnRH and artificial insemination is recommended.
Artificial insemination should be carried out in accordance with the usual field recommendations, i.e., 12 to 24 hours after oestrus detection.
Induction and synchronisation of oestrus and ovulation in combination with prostaglandin F (PGF) with or without progesterone as part of Fixed Time Artificial Insemination (FTAI) protocols
The following FTAI protocols have been commonly reported in the literature:
In cycling cows:
Day 0: Inject 100 micrograms of gonadorelin (as acetate) per animal (2 ml of the product)
Day 7: Inject PGF or analogue (luteolytic dose)
Day 9: Inject 100 micrograms of gonadorelin (as acetate) per animal (2 ml of the product)
Artificial insemination 16–20 hours later, or at observed oestrus if sooner.
Alternatively:
Day 0: Inject 100 micrograms of gonadorelin (as acetate) per animal (2 ml of the product)
Day 7: Inject PGF or analogue (luteolytic dose)
Artificial insemination and injection of 100 micrograms of gonadorelin (as acetate) per animal (2 ml of the product) 60–72 hours later, or at observed oestrus if sooner.
In cycling and non-cycling cows and heifers:
Insert intravaginal progesterone releasing device for 7-8 days.
Inject 100 micrograms of gonadorelin (as acetate) per animal (2 ml of the product) at progesterone device insertion.
Inject a luteolytic dose of PGF or analogue 24 hours prior to device removal.
FTAI 56 hours after removal of the device, or
Inject 100 micrograms of gonadorelin (as acetate) per animal (2 ml of the product) 36 hours after progesterone releasing device removal and FTAI 16 to 20 hours later.
Contra-indications, warnings, etc
Do not use in animals with known hypersensitivity to gonadorelin and to any other ingredients of the product.
Do not use for shortening of oestrus during infectious diseases and other relevant disorders.
In the treatment of cystic ovaries, the condition of ovarian follicular cysts should be diagnosed by rectal palpation revealing the presence of persisting follicular structures with a diameter over 2.5 cm and should be confirmed by the use of plasma or milk progesterone assay.
The product should be administered at least 14 days after calving due to the absence of receptivity of the hypophysis before that time.
For induction and synchronisation of oestrus and ovulation in Fixed Time Artificial Insemination (FTAI) protocols, the product should be administered at least 35 days after calving. The response of cows and heifers to synchronisation protocols is influenced by the physiological state at the time of treatment. Responses to treatment can vary either across herds or across cows within herds. However, the percentage of cows displaying oestrus within a given period is usually greater than in untreated cows and the subsequent luteal phase is of normal duration.
For protocol that includes PGF: To maximise conception rates of cows to be treated, the ovarian status should be determined and regular cyclic ovarian activity confirmed. Optimal results will be achieved in healthy normally-cycling cows.
Animals in poor condition, whether from illness, inadequate nutrition or other factors, may respond poorly to treatment.
Not indicated for use during pregnancy. No contraindications have been described during lactation.
At up to 5 times the recommended dose and in a regimen extended from one to three daily administrations, no measurable signs of either local or general clinical intolerance were observed.
A synergistic effect occurs in case of combined administration of FSH.
Withdrawal period
Meat and offal: zero days.
Milk: zero hours.
User warnings
Care should be taken when handling the product to avoid self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Care should be taken to avoid skin and eye contact. In case of skin contact, rinse immediately and thoroughly with water as GnRH analogues can be absorbed through the skin. In case of accidental contact with eyes, rinse thoroughly with plenty of water.
The effects of accidental exposure in pregnant women or in women with normal reproductive cycles are unknown; therefore it is recommended that pregnant women should not administer the product, and that women of child-bearing age should administer the product with caution.
People with known hypersensitivity to GnRH analogues, should avoid contact with the veterinary medicinal product.
Pharmaceutical precautions
Do not store above 25°C.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Do not use after the expiry date which is stated on the label.
Shelf-life after first opening the container is 28 days.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Supplied in cardboard boxes with 1 vial of 6, 10, 20, 50 or 100 ml or cardboard boxes with 10 vials of 6 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder (if different from distributor)
Laboratorios SYVA, Spain
Marketing Authorisation Number
Vm 31592/4005
Significant changes
GTIN
GTIN description:Acegon 10 x 6 ml:
GTIN:08436529620818
GTIN description:Acegon 20 ml:
GTIN:08436529620801