Cyclix porcine 87.5 microgram/ml solution for injection

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Cloprostenol sodium

Verfügbar ab:

Virbac S.A.

ATC-Code:

QG02AD90

INN (Internationale Bezeichnung):

Cloprostenol sodium

Dosierung:

87.5 microgram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Pigs

Therapiebereich:

cloprostenol

Anwendungsgebiete:

Hormone

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2008-11-28

Fachinformation

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclix 87.5 µg/ml solution for injection for pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Cloprostenol 87.5 µg
as Cloprostenol sodium 92 µg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Benzyl alcohol (E1519)
20 mg
Citric Acid Monohydrate (as a pH adjuster)
Sodium Citrate
Sodium Chloride
Sodium Hydroxide (as a pH adjuster)
Water for injections
Colourless solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs (sows).
3.2
INDICATIONS FOR USE FOR EACH 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).
3.3
CONTRAINDICATIONS
Do not use in pregnant animals, for which induction of abortion or
parturition is not intended. Do not
use in the case of dystocic parturition (for example due to abnormal
position of the foetus or mechanical
obstruction).
Do not use in animals with spastic diseases of the respiratory or
gastrointestinal tract.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
None.
3
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The veterinary medicinal 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 preca