Target species
Cattle (cows, heifers), horses (mares), rabbits (adult females), pigs (sows, gilts) and trout.
Indications for use
Cattle (cows, heifers):
•Treatment of infertility associated with follicular cysts.
•Induction and synchronisation of oestrus and ovulation in combination with prostaglandin F2α (PGF2α) or its analogues, with or without progestogens, as part of a timed artificial insemination protocol.
•Improvement in conception and / or pregnancy rates in cows with low fertility during the luteal phase following artificial insemination.
Horses (mares):
•Induction of ovulation and improvement of conception and / or pregnancy rates.
Pigs (sows, gilts):
•Induction of ovulation following oestrus synchronisation as part of an insemination program.
Rabbits (adult females):
•Induction of ovulation and improvement in conception rates.
Trout:
•Facilitation of strip spawning.
•Reduction of mortality after stripping.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Treatment with a GnRH analogue does not eliminate the underlying cause(s) of the fertility disorder.
Residues of alcohol and disinfectants may affect the activity of buserelin. Therefore, care should be taken to ensure that skin and/or stopper of the vial are completely dry after disinfection before piercing.
Cattle (cows, heifers):
Cattle with a short interval between calving and insemination (< 60 days), low body condition score or high parity may have a lower pregnancy rate after a standard synchronization protocol (see section ‘Amounts to be administered and administration route’). There is no guarantee that all cows synchronized according to protocol will be in oestrus at the time of artificial insemination. The chances of conception may be higher if the cow is in oestrus at the time of insemination.
Pigs (sows, gilts):
The presence of a boar at the time of artificial insemination is recommended.
Animals should be checked for signs of oestrus before insemination.
A negative energy balance during lactation may be associated with mobilization of body reserves resulting in a sharp decrease in the thickness of the fat on the back (more than about 30%). In these animals, oestrus and ovulation may be delayed, and these animals should be cared for and bred on an individual basis.
Special precautions for use
Infection may occur if anaerobic bacteria penetrate tissue at the injection site, in particular following intramuscular injection. Use aseptic techniques when injecting the veterinary medicinal product.
Operator warnings
Buserelin may affect reproductive function, as it has been shown to be foetotoxic in laboratory animals.
Women of childbearing age should handle this veterinary medicinal product with caution. Pregnant women should not administer this veterinary medicinal product.
When administering the veterinary medicinal product, care should be taken to avoid eye and skin contact or accidental self-injection.
In case of accidental eye contact, rinse thoroughly with water. Should skin contact with the veterinary medicinal product occur, wash exposed area immediately with soap and water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
People with known hypersensitivity to GnRH analogues or benzyl alcohol should avoid contact with the veterinary medicinal product.
Adverse reactions
Cattle (cows, heifers), horses (mares), pigs (sows, gilts), rabbits (adult females), trout:
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.
Use during pregnancy or lactation
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during all stages of pregnancy in the target animal species.
The veterinary medicinal product is indicated for use in female animals at or close to the time of mating or insemination, and as such, use during the luteal phase (after ovulation) is considered safe for use in lactating and non-lactating animals.
Interactions
None known.
Amounts to be administered and administration route
Routes of administration:
Cattle, horses, pigs, rabbits: intramuscular, intravenous or subcutaneous use.
Trout: intramuscular use, 2 cm above the lateral line posterior to the dorsal fin.
The stopper may be safely punctured up to 12 times. When treating groups of animals at the same time, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper. The draw-off needle should be removed after treatment.
Dosage:
Cattle (cows, heifers): Depending on the indication, a single dose of 10 mcg buserelin per animal (corresponding to 2.5 ml of the veterinary medicinal product) or 20 mcg buserelin per animal (corresponding to 5.0 ml of the veterinary medicinal product).
Horses (mares): A single dose of 40 mcg buserelin per animal (corresponding to 10 ml of the veterinary medicinal product).
Pigs (sows, gilts): A single dose of 10 mcg buserelin per animal (corresponding to 2.5 ml of the veterinary medicinal product).
Rabbits (adult females): A single dose of 0.8 mcg buserelin per animal (corresponding to 0.2 ml of the veterinary medicinal product).
Trout: A single dose of 3 – 4 mcg buserelin per kg bodyweight (corresponding to 0.75 – 1.0 ml of the veterinary medicinal product).
Protocols for use:
Cattle (cows, heifers)
Treatment of infertility associated with follicular cysts:
Administer a single dose of 20 mcg buserelin per animal.
A response to treatment is expected within 10-14 days. If a palpable corpus luteum does not develop, or a new cyst forms, the treatment should be repeated. Insemination should be performed at the first oestrus after treatment.
Induction and synchronisation of oestrus and ovulation in combination with prostaglandin F2α (PGF2α) or its analogues, with or without progestogens, as part of a timed artificial insemination protocol:
Judgement on the protocol should be chosen by the responsible veterinarian, on the basis of the intended objective and characteristics of the individual herd or animal. The following protocols have been evaluated and could be used:
In cyclic cows:
Day 0: Administer a single dose of 10 mcg buserelin per animal.
Day 7: Administer prostaglandin or analogue (at luteolytic dosage).
Day 9: Administer a single dose of 10 mcg buserelin per animal.
Artificial insemination 16 to 24 hours after the second (buserelin) injection of this veterinary medicinal product or at the time of oestrus, if earlier.
In cyclic and non-cyclic cows:
Day 0: Administer a single dose of 10 mcg buserelin per animal and insert a progestogen-releasing insert.
Day 7: Remove the progestogen-releasing insert and administer prostaglandin or its analogue (at luteolytic dosage).
Day 9: Administer a single dose of 10 mcg buserelin per animal.
Artificial insemination 16 to 24 hours after the second (buserelin) injection of this veterinary medicinal product or at the time of oestrus, if earlier.
Alternatively:
Day 0: Administer a single dose of 10 mcg buserelin per animal and insert a progestogen-releasing insert.
Day 7: Remove the progestogen-releasing insert and administer prostaglandin or its analogue (at luteolytic dosage) and PMSG (400 – 500 IU).
Day 9: Administer a single dose of 10 mcg buserelin per animal.
Artificial insemination 16 to 24 hours after the second (buserelin) injection of this veterinary medicinal product or at the time of oestrus, if earlier.
Improvement in conception and / or pregnancy rates in cows with low fertility, during the luteal phase following artificial insemination:
Administer a single dose of 10 mcg buserelin per animal 11 - 13 days after insemination.
Horses (mares)
Induction of ovulation and improvement in conception and / or pregnancy rates:
Administer a single dose of 40 mcg buserelin per animal on the first day that the follicle reaches its optimal size (as determined by previous clinical history and transrectal examinations).
Ovulation usually occurs within 24 - 36 hours after treatment; if the mare has not ovulated during this period, administration should be repeated.
Pigs (sows, gilts)
Induction of ovulation following oestrus synchronisation as part of an insemination program
Gilts: Administer a single dose of 10 mcg buserelin per animal between 115 - and 120 - hours following oestrus synchronization with a progestogen. A single artificial insemination should be performed 30 - 33 hours after administration of the veterinary medicinal product.
Sows: Administer a single dose of 10 mcg buserelin per animal 83 - 89 hours after weaning. A single artificial insemination should be performed 30 - 33 hours after administration of the veterinary medicinal product.
In individual cases, oestrus may not be visible 30 - 33 hours after treatment with the veterinary medicinal product. In such cases, insemination can be carried out later, at a time when oestrus symptoms are present.
Rabbits (adult females)
Induction of ovulation and improvement in conception rates:
Administer a single dose of 0.8 mcg buserelin per animal at the time of mating or insemination.
For post-partum insemination, administer a single dose of 0.8 mcg buserelin no less than 24 hours post-partum, followed immediately by insemination.
Trout
Facilitation of strip spawning and reduction of mortality after stripping:
Administer a single dose of 3-4 mcg buserelin per kg bodyweight to fish in spawning condition. Stripping should be performed 2-3 days after treatment with the veterinary medicinal product.
Overdose
None known.
Withdrawal periods
Cattle, horses
Meat and offal: Zero days.
Milk: Zero hours.
Pigs, rabbits
Meat and offal: Zero days.
Trout
Meat and offal: Zero degree days.