VETERELIN 0.004 mg/ml Solution for Injection for Cattle, Horses, Pigs, and Rabbits

Страна: Велика Британія

мова: англійська

Джерело: VMD (Veterinary Medicines Directorate)

Активний інгредієнт:

Buserelin

Доступна з:

Laboratorios Calier, SA

Код атс:

QH01CA90

ІПН (Міжнародна Ім'я):

Buserelin

Фармацевтична форма:

Solution for injection

Тип рецепту:

POM-V - Prescription Only Medicine – Veterinarian

Терапевтична група:

Cattle, Horses, Pigs, Rabbits

Терапевтична области:

Hormone sex

Статус Авторизація:

Authorized

Дата Авторизація:

2011-08-05

Характеристики продукта

Revised: July 2023
AN: 02295/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETERELIN 0.004 mg/ml solution for injection for cattle, horses, pigs,
and rabbits
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ml contains:
ACTIVE SUBSTANCE:
Buserelin
..........................................................0.004 mg
(equivalent to 0.0042 mg Buserelin acetate)
EXCIPIENTS:
Benzyl alcohol (E 1519).........................................10 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4. CLINICAL PARTICULARS
4.1TARGET SPECIES
Cattle (cows), horses (mares), pigs (sows and gilts), rabbits (female
rabbits for
reproduction).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
FOR COWS:
- Ovulation induction or delayed ovulation
- Treatment of anoestrus
- Treatment of follicular cysts with or without symptoms of
nymphomania
- 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.
Revised: July 2023
AN: 02295/2022
Page 2 of 7
FOR MARES:
- Ovulation induction and thereby to synchronise ovulation more
closely with mating
in mares.
- Treatment of follicular cysts – with or without symptoms of
nymphomania
FOR FEMALE RABBITS FOR REPRODUCTION:
Improvement
of
conception
rate
and
ovulation
induction
at
post-partum
insemination.
FOR SOWS (SEXUALLY MATURE GILTS):
Ovulation induction after oestrus synchronisation with an analogue of
progestagen
(altrenogest) in order to perform a single artificial insemination.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment
with
a
GnRH
(gonadotrophin
releasing
hormone)
analogue
is
only
symptomatic; the causes underlying a fertility disorder are not
eliminated by this
treatment.
4.5 SPECIAL PRECAUTIONS FOR USE
i