Maprelin 75 µg/ml Solution for Injection for Pigs

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Peforelin

Dostopno od:

VEYX-PHARMA GMBH

Koda artikla:

QH01CA95

INN (mednarodno ime):

Peforelin

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Pigs

Terapevtsko območje:

Hormone sex

Status dovoljenje:

Authorized

Datum dovoljenje:

2009-06-24

Lastnosti izdelka

Revised: March 2014
AN. 01333/2012
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Maprelin 75 µg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
ACTIVE SUBSTANCE:
Peforelin
75.00 µg
EXCIPIENTS:
Chlorocresol 1.00 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (sows and gilts)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For zootechnical use and intended for group or herd treatment.
•
Induction of the oestrous cycle in sows after weaning
•
Induction of oestrus in sexually mature gilts following therapy to
inhibit the oestrus
cycle with progestagens
4.3
CONTRAINDICATIONS
Do not use in prepubertal gilts, in case of infertility or general
health disorders.
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients_._
Revised: March 2014
AN. 01333/2012
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
The product might induce irritation and sensitization.
People with known hypersensitivity to GnRH analogues or any of the
excipients
should avoid contact with the veterinary medicinal product. The
veterinary medicinal
product should not be administered by pregnant women, as an accidental
self-
injection by the user cannot be excluded and because GnRH analogues
have been
shown to be foetotoxic in laboratory animals. Women of childbearing
age should
administer the product with special caution.
In the case of accidental self-injection, seek medical advice
immediately and show
the package leaflet or the label to the physician.
In case of accidental contact with the skin, the corresponding area
should be
thoroughly cleaned with soap and water, as