SYNCROPROST SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOPROSTENOL (CLOPROSTENOL SODIUM)

Available from:

ALIVIRA ANIMAL HEALTH LIMITED

Dosage:

0.25MG

Pharmaceutical form:

SOLUTION

Composition:

CLOPROSTENOL (CLOPROSTENOL SODIUM) 0.25MG

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Prescription

Therapeutic group:

CATTLE

Product summary:

Active ingredient group (AIG) number: 0112396001

Authorization status:

APPROVED

Authorization date:

2023-08-18

Patient Information leaflet

VDD VERSION 00 27JUL2023
Syncroprost Product Insert
DIN XXXXXXXX
VETERINARY USE ONLY
PR SYNCROPROST
TM
Cloprostenol injection BP
Sterile Synthetic Prostaglandin for Cattle
DESCRIPTION
Cloprostenol sodium is a synthetic prostaglandin analogue,
structurally related to prostaglandin
F
2
(PGF
2
).
Chemical
name:
(±)-Sodium
(5Z)-7-(1R,3R,5S)-2-[(1E,3R)-4-(3-chlorophenoxy)-3-
hydroxybut-1-enyl]-3,5-dihydroxycyclopentylhept-5-enoate.
Empirical formula: C
22
H
28
ClNaO
6
, Molecular weight: 446.9 g/mol.
Chemical structure:
ACTIVE INGREDIENT:
Each mL contains Cloprostenol 0.25 mg (equivalent to 0.263 mg of
cloprostenol sodium BP).
PRESERVATIVE:
Chlorocresol 1.0 mg/mL
NON-MEDICINAL INGREDIENTS:
Ethanol 96%, Sodium citrate, Sodium chloride, Citric acid monohydrate,
Water for injections
INDICATIONS
By its ability to shorten the life span of the
_corpus luteum_
(C.L)
Syncroprost
can be used to
treat certain clinical conditions which delay breeding, to manipulate
the estrous cycle to better
fit certain management practices, and to induce abortion.
THERAPEUTIC INDICATIONS
SUB-ESTRUS (SILENT HEAT OR NON-DETECTED ESTRUS):
Cows which fail to exhibit normal estrous
behaviour although ovarian cyclicity continues can be treated
Syncroprost
while in the luteal
phase of the estrous cycle. They may then either be closely observed
for estrus over a scheduled
time period and bred on detection of estrus or bred at 72 and 96 hours
after injection without
estrus detection.
PYOMETRA OR CHRONIC ENDOMETRITIS:
Damage to the reproductive tract at calving or postpartum
retention of the placenta frequently leads to infection and
inflammation of the uterus which is
usually referred to as endometritis. Under certain circumstances, this
may progress into chronic
endometritis with the uterus becoming distended with purulent matter.
This condition, VDD VERSION 00 27JUL2023
frequently referred to as pyometra, is characterized by lack of
cyclical estrous behaviour and
the presence of a persistent
_corpus luteum_
. This condition can be successfully treat