Cyclix 250 microgram/ml Solution for Injection for Cattle

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Cloprostenol

Διαθέσιμο από:

Virbac

Φαρμακολογική κατηγορία (ATC):

QG02AD90

INN (Διεθνής Όνομα):

Cloprostenol

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cattle

Θεραπευτική περιοχή:

Prostaglandin

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2006-02-09

Αρχείο Π.Χ.Π.

Revised: June 2020
AN: 00694/2019
Page 1 of 5
THE SPC/QRDSUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclix 250 microgram/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
ACTIVE SUBSTANCE(S):
Cloprostenol sodium 263 micrograms
(corresponding to 250 micrograms cloprostenol)
EXCIPIENT(S):
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
Cows
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Induction of luteolysis allowing resumption of oestrus and ovulation
in cyclic females
when used during dioestrus, synchronisation of oestrus (within 2 to 5
days) in groups
of
cyclic
females
treated
simultaneously,
treatment
of
suboestrus
and
uterine
disorders
related
to
a
functioning
or
persistent
corpus
luteum
(endometritis,
pyometra), treatment of ovarian luteal cysts, induction of abortion
until day 150 of
pregnancy, expulsion of mummified foetuses, induction of parturition.
4.3
CONTRAINDICATIONS
Do not use in pregnant animals, for which induction of abortion or
parturition is not
intended.
Do
not
use
in
animals
with
spastic
diseases
of
the
respiratory
or
gastrointestinal tract.
Revised: June 2020
AN: 00694/2019
Page 2 of 5
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 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 alcohol should avoid
contact with the
product.
Do not eat, drink or smoke while handling the product.
Direct contact with skin or mucous membranes of the user should be
avoided.
Pr