Busol - 0.004 mg/ml Solution for Injection for Cattle, Horses, Rabbits

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Buserelin

Dostępny od:

aniMedica GmbH

Kod ATC:

QH01CA90

INN (International Nazwa):

Buserelin

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Cattle, Horses, Rabbits

Dziedzina terapeutyczna:

Hormone

Status autoryzacji:

Authorized

Data autoryzacji:

2006-01-25

Charakterystyka produktu

Revised: June 2022
AN: 02224/2021 & 02226/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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)
EXCIPIENT(S):
Benzyl alcohol
20.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, horse, rabbit
4.2
INDICATIONS FOR USE SPECIFYING THE 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 PGF2α 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
In rabbits:
- Improvement of conception rate
- Induction of ovulation in post partum insemination.
Revised: June 2022
AN: 02224/2021 & 02226/2021
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment with a GnRH analogue is only symptomatic; the causes
underlying a fertility
disorder are not eliminated by this treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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 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 product, as buserelin has
been shown to be
foetotoxic in laboratory animals. When administering the product, care
should be taken to
avoid acci