Cyclix Porcine 87.5 Microgram/ml Solution for Injection

Summary of Product characteristics

                                Revised : February 2020
AN: 00693/2019
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclix Porcine solution for injection (87.5 microgram/ml).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 ml solution for injection contains:
Cloprostenol sodium ..........................92 micrograms
(corresponding to 87.5 micrograms cloprostenol)
EXCIPIENTS:
Benzyl alcohol (E1519)
20 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
Colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sows.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Induction
or
synchronisation
of
farrowing
(within
16
to
34
hours)
from
day
113
of
pregnancy onwards (day 1 of pregnancy is the last day of natural or
artificial insemination).
4.3
CONTRAINDICATIONS
Do not use in pregnant animals, for which induction of abortion or
parturition is not
intended. Do not use in the case of distocic parturition due to
abnormal position of the
foetus, mechanical obstruction, etc….
Do not use in animals with spastic diseases of the respiratory or
gastrointestinal tract.
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
Revised : February 2020
AN: 00693/2019
Page 2 of 5
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The product should only be used on farms where accurate insemination
records are kept.
Do not use before day 113 of pregnancy, as this may lead to increased
mortality and
reduced vitality of new-born piglets. Induction of labour before the
111
th
day of gestation
may cause mortality in piglets and an increase in the number of sows
that require manual
assistance.
As
with
parenteral
administration
of
any
substance,
basic
aseptic
rules
should
be
observed. The injection site must be thoroughly cleaned and
disinfected in order to reduce
the risk of infection with anaerobic bacteria.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
People with known hypersensitivity to benzyl alcoho
                                
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