Prellim 0.075 mg/ml Solution for Injection for Cattle and Pigs

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

d-Cloprostenol

Διαθέσιμο από:

Laboratorios SYVA S.A.U

Φαρμακολογική κατηγορία (ATC):

QG02AD90

INN (Διεθνής Όνομα):

d-Cloprostenol

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cattle, Pigs

Θεραπευτική περιοχή:

Prostaglandin

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2009-05-08

Αρχείο Π.Χ.Π.

Revised: April 2022
AN: 01370/2021, 01377/2021, 02252/2021 & 02255/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prellim 0.075 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
d-Cloprostenol (as d-Cloprostenol sodium)...................0.075 mg
EXCIPIENT:
Chlorocresol
.........................................................................1
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution, free from particles in suspension.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cattle (cows) and pigs (sows).
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE (COWS)
INDICATIONS
FOR
REPRODUCTION:
synchronization
or
induction
of
oestrus.
Induction of parturition.
THERAPEUTIC INDICATION: ovarian dysfunction (persistent corpus luteum,
luteal
cyst),
interruption
of
pregnancy
including
foetal
mummification,
endometritis/pyometra, delayed uterine involution.
PIGS (SOWS)
INDICATIONS FOR REPRODUCTION: Induction of parturition.
4.3
CONTRAINDICATIONS
See section 4.7
Do not use in case of hypersensitivity to the active substance, or to
any of the
excipients.
Do not use in animal with spastic respiratory or gastro-intestinal
diseases.
Revised: April 2022
AN: 01370/2021, 01377/2021, 02252/2021 & 02255/2021
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As with parenteral administration of any substance, basic antiseptic
rules should
be observed. The injection site must be thoroughly cleaned and
disinfected in
order to reduce the risk of infection with anaerobic bacteria.
Pigs: use only when precise date of insemination is known. Administer
on day
113 of gestation, at the earliest. The veterinary medicinal product
administered
earlier, may impair the viability and weight of piglets.
Special precautions to be taken by the person administe