Lutalyse 5 mg/ml Solution for Injection

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Dinoprost

Saatavilla:

Zoetis UK Limited

ATC-koodi:

QG02AD01

INN (Kansainvälinen yleisnimi):

Dinoprost

Lääkemuoto:

Solution for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cattle, Horses, Pigs

Terapeuttinen alue:

Prostaglandin

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2005-10-07

Valmisteyhteenveto

Revised: April 2021
AN: 01269/2020
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Lutalyse 5 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Dinoprost (as Dinoprost Trometamol)
5 mg
EXCIPIENTS:
Benzyl Alcohol (E1519).
16.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear and colourless solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, horses and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Lutalyse is indicated for its luteolytic and/or oxytocic effects in
cattle, horses and
pigs. The indications for use are:
CATTLE
1.
To more effectively control the time of oestrus in cycling cows.
2.
To treat cows which have a functional corpus luteum, but do not
express
behavioural oestrus (sub-oestrus or silent heat).
3.
To induce abortion.
4.
To induce parturition.
5.
For treatment of chronic metritis and pyometra.
6.
For controlled breeding in normally-cycling dairy cows:
- oestrus synchronisation
-
ovulation
synchronisation
in
combination
with
GnRH
or
GnRH
analogues as part of fixed time artificial insemination protocols.
Revised: April 2021
AN: 01269/2020
Page 2 of 10
MARES
1.
To more effectively control the time of oestrus in cycling mares.
2.
To treat mares which have a functional corpus luteum but do not
express
behavioural oestrus.
3.
To induce abortion.
PIGS
1.
Induction of parturition
2.
To reduce the weaning to oestrus interval (WOI) and the weaning to
fertile
service
interval
(WFSI)
in
sows
in
herds
with
reproductive
problems.
4.3
CONTRAINDICATIONS
Contra-indicated in animals suffering from either acute or sub-acute
disorders of
the
vascular
system,
gastro-intestinal
tract
or
respiratory
system.
Contra-
indicated when abortion or parturition is not intended.
Do not administer by the intravenous route.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
CATTLE:
Localized
post
injection
bacterial
infections
that
may
become
generalized
hav