Busol 0.004 mg/ml solution for injection 10ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Busol – 0.004 mg/ml solution for injection for Cattle, Horses, Rabbits
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Buserelin acetate 0.0042 mg
(equivalent to Buserelin 0.004 mg)
Excipients:
Qualitative composition of excipients
and other constituent
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Benzyl alcohol 20.0 mg
Sodium chloride
Sodium dihydrogenphosphate 2H2O
Sodium hydroxide
Water for injections
Clear, colourless solution.
3. CLINICAL INFORMATION
3.1 Target species
Cattle, horses, rabbits
3.2 Indications for use for each target species
In cattle:
- Early cycle induction post partum
- Treatment of follicular cysts
- Improvement of conception rate in artificial insemination procedures, also after
synchronisation of oestrus with a PGF2a analogue. Results may however vary depending
on breeding conditions.
In horses:
- Induction of ovulation to synchronise ovulation more closely with mating
- Improvement of conception rate
Revised: February 2025
AN: 01413/2024 & 01414/2024
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In rabbits:
- Improvement of conception rate
- Induction of ovulation in post partum insemination.
3.3 Contraindications
None.
3.4 Special warnings
Treatment with a Gonadotropin releasing hormone (GnRH) analogue is only symptomatic;
the causes underlying a fertility disorder are not eliminated by this treatment.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Observe aseptic precautions.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Avoid eye and skin contact with the solution for injection. In case of accidental eye contact,
rinse thoroughly with water. Should skin contact with the veterinary medicinal product
occur, wash the exposed area immediately with soap and water, as GnRH analogues may
be absorbed through the skin.
Pregnant women should not administer the veterinary medicinal product, as buserelin has
been shown to be foetotoxic in laboratory animals. When administering the veterinary
medicinal product, care should be taken to avoid accidental self-injection by ensuring that
animals are suitably restrained and the application needle is shielded until the moment of
injection. Women of child-bearing age should administer the veterinary medicinal product
with caution. In case of accidental self-injection, seek medical advice immediately and
show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
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.
3.7 Use during pregnancy, lactation or lay
The veterinary medicinal product is intended for use to improve pregnancy rate, induce
ovulation etc. and should therefore be used prior to mating or insemination and not during
pregnancy.
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AN: 01413/2024 & 01414/2024
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3.8 Interaction with other medicinal products and other forms of interaction
No data available.
3.9 Administration routes and dosage
Intramuscular, intravenous or subcutaneous use.
The dose per animal is 10 to 20 µg buserelin in cows, 20 to 40 µg buserelin in mares and
0.8 µg buserelin in rabbits.
Species / Indication ml of the veterinary
medicinal product
µg
Buserelin
Cattle
Fertility disorders of ovarian origin, in
particular:
Follicular cysts with or without
symptoms of nymphomania
5 ml 20 µg
Early cycle induction post partum 5 ml 20 µg
Improvement of conception rate in
artificial insemination procedures,
also after synchronisation of oestrus
with a PGF2a analogue.
(Results may however vary
depending on breeding conditions)
2.5 ml 10 µg
Mares
Induction of ovulation to synchronise
ovulation more closely with mating.
(If ovulation has not occurred within
24 hours after treatment, then the
injection should be repeated.)
10 ml 40 µg
Improvement of conception rate 10 ml 40 µg
Rabbits
For improving the conception rate 0.2 ml 0.8 µg
Induction of ovulation in post partum
insemination
0.2 ml 0.8 µg
This veterinary medicinal product is preferably given by intramuscular injection. The
intravenous or subcutaneous route may also be used. The veterinary medicinal product
should be administered once.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
No data on overdosing are available.
Revised: February 2025
AN: 01413/2024 & 01414/2024
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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.
3.12 Withdrawal periods
Cattle, horses, rabbits
Meat and offal Zero days
Cattle, horses
Milk Zero hours
4. PHARMACOLOGICAL INFORMATION
4.1 ATCvet code:
QH01CA90
4.2 Pharmacodynamics
Buserelin is a peptide hormone and a synthetic hypothalamic releasing hormone analogue
for the gonadotropins LH (luteinising hormone) and FSH (follicle stimulating hormone). The
mechanism of action of buserelin is identical to that of natural gonadotropin releasing
hormone (GnRH): After hypothalamic neurosecretion, buserelin stimulates the release of
FSH and LH from the pituitary into the bloodstream. Via the blood circulation, these
hormones act on the ovary to result in follicular maturation, ovulation and luteinisation.
4.3 Pharmacokinetics
After intravenous administration, buserelin is degraded very rapidly: Its half-life is 3 to 4.5
minutes in rats and 12 minutes in guinea-pigs. Buserelin accumulates in the liver, kidneys
and pituitary; particularly high concentrations are found in the pituitary approximately 60
minutes post-dose. Enzymatic breakdown of buserelin is detectable in the hypothalamus,
pituitary, liver and kidneys.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be
mixed with other veterinary medicinal products.
5.2 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
Revised: February 2025
AN: 01413/2024 & 01414/2024
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5.3 Special precautions for storage
Do not store above 25 C.
5.4 Nature and composition of immediate packaging
Clear glass (type I) vials closed with a bromobutyl rubber stopper and sealed with an
aluminium crimp cap.
Pack size:
5 vials of 10 ml in a cardboard box
Multipack sizes:
50 (10x5) vials of 10 ml in a cardboard box
100 (20x5) vials of 10 ml in a cardboard box
250 (50x5) vials of 10 ml in a cardboard box
500 (100x5) vials of 10 ml in a cardboard box
Not all pack sizes may be marketed.
5.5 Special precautions for the disposal of unused veterinary medicinal product or
waste materials derived from the use of such products
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.