Porceptal 4 micrograms/ml Solution for Injection for Pigs

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Buserelin

Disponibil de la:

MSD Animal Health UK Limited

Codul ATC:

QH01CA90

INN (nume internaţional):

Buserelin

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Pigs

Zonă Terapeutică:

Hormone

Statutul autorizaţiei:

Expired

Data de autorizare:

2013-12-12

Caracteristicilor produsului

Revised: November 2018
AN: 02466/2017
Page 1 of 6
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Revised: November 2018
AN: 02466/2017
Page 2 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porceptal 4 micrograms/ml solution for injection for pigs
DK: Porceptal Vet 4 micrograms/ml injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml:
ACTIVE SUBSTANCE:
Buserelin acetate
4.2 µg
(corresponding to 4 µg buserelin)
EXCIPIENTS:
Benzyl alcohol E1519
20.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (gilts and sows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Induction of ovulation after oestrus synchronisation by weaning (sows)
or by
administration of a progestin (gilts) to be used as part of a single
fixed time artificial
insemination program.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Buserelin is given after oestrus synchronisation. In gilts, buserelin
is given after
progestin treatment. Provided that the progestin treatment is ended
simultaneously in
a group of gilts, it causes a synchronisation of oestrus in the
treated animals. In
sows, oestrus synchronisation is achieved naturally by weaning.
Insemination can be done at 30-33 hours after buserelin injection.
When using this
product, the animals should be checked for signs of oestrus at the
time of artificial
insemination. Therefore the presence of the boar is recommended.
It may happen that negative energy balance during lactation is
associated with
mobilisation of body reserves with a large drop in backfat thickness
(more than
Revised: November 2018
AN: 02466/2017
Page 3 of 6
approximately 30 %). In such animals, oestrus and ovulation may be
delayed and
these animals should be managed and bred on a case by case basis.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In sows and sexually mature gilts, use of the product contrary to the
recommended
protoco