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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

d-Cloprostenol

Available from:

Laboratorios SYVA S.A.U

ATC code:

QG02AD90

INN (International Name):

d-Cloprostenol

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Prostaglandin

Authorization status:

Authorized

Authorization date:

2009-05-08

Summary of Product characteristics

Revised: April 2023
AN: 01009/2022 & 01045/2022
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
EXCIPIENTS:
QUALITATIVE COMPOSITION OF
EXCIPIENTS AND OTHER CONSTITUENTS_ _
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Chlorocresol
1 mg
Ethanol (96%)
Citric acid monohydrate
Sodium hydroxide
Water for injections
Clear, colourless solution for injection, free from particles in
suspension.
3.
CLINICAL INFORMATION
3.1.
TARGET SPECIES
Cattle (cows) and pigs (sows).
3.2
INDICATIONS FOR USE FOR EACH 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.
Revised: April 2023
AN: 01009/2022 & 01045/2022
Page 2 of 6
PIGS (SOWS)
INDICATIONS FOR REPRODUCTION: Induction of parturition.
3.3
CONTRAINDICATIONS
See section 3.7
Do not use in cases of hypersensitivity to the active substance, or to
any of the
excipients.
Do not use in animals with spastic respiratory or gastro-intestinal
diseases.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species
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 prec