SYNCHSURE- cloprostenol sodium injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
15-06-2016

Aktivna sestavina:

cloprostenol sodium (UNII: 886SAV9675) (cloprostenol - UNII:4208238832)

Dostopno od:

Merial, Inc.

INN (mednarodno ime):

cloprostenol sodium

Sestava:

cloprostenol 250 ug in 1 mL

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION

Terapevtske indikacije:

INDICATIONS: For intramuscular use to induce luteolysis in beef and dairy cattle. The luteolytic action of SYNCHSURE can be utilized to manipulate the estrous cycle to better fit certain management practices, to terminate pregnancies resulting from mismatings, and to treat certain conditions associated with prolonged luteal function. CONTRAINDICATIONS: SYNCHSURE should not be administered to a pregnant animal whose calf is not to be aborted.

Povzetek izdelek:

HOW SUPPLIED: 100mL multidose vial

Status dovoljenje:

Abbreviated New Animal Drug Application

Lastnosti izdelka

                                SYNCHSURE- CLOPROSTENOL SODIUM INJECTION, SOLUTION
MERIAL, INC.
----------
SYNCHSURE™
(CLOPROSTENOL SODIUM)
ANADA 200-310, Approved by FDA
PROSTAGLANDIN ANALOGUE FOR CATTLE
Equivalent to 250 mcg cloprostenol/mL
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION:
SYNCHSURE™ (cloprostenol sodium) is a synthetic prostaglandin
analogue structurally related to
prostaglandin F
(PGF
). Each mL of the colorless aqueous solution contains 263 mcg of
cloprostenol sodium (equivalent to 250 mcg of cloprostenol),
chlorocresol 1.0 mg as a bactericide,
citric acid anhydrous 0.66 mg, sodium citrate 5.03 mg, sodium chloride
6.76 mg. The pH is adjusted, as
necessary, with sodium hydroxide or citric acid.
ACTION:
SYNCHSURE causes functional and morphoIogical regression of the
_corpus luteum_ (luteolysis) in
cattle. In normal, nonpregnant cycling animals, this effect on the
life span of the _corpus luteum_ usually
results in estrus 2 to 5 days after treatment. In animals with
prolonged luteal function (pyometra,
mummified fetus, and luteal cysts), the induced luteolysis usually
results in resolution of the condition
and return to cyclicity. Pregnant animals may abort depending on the
stage of gestation.
INDICATIONS:
For intramuscular use to induce luteolysis in beef and dairy cattle.
The luteolytic action of
SYNCHSURE can be utilized to manipulate the estrous cycle to better
fit certain management practices,
to terminate pregnancies resulting from mismatings, and to treat
certain conditions associated with
prolonged luteal function.
RECOMMENDED USES:
UNOBSERVED OR NONDETECTED ESTRUS
Cows which are not detected in estrus, although ovarian cyclicity
continues, can be treated with
2α
2α
SYNCHSURE if a mature _corpus luteum_ is present. Estrus is expected
to occur 2 to 5 days following
injection, at which time animals may be inseminated. Treated cattle
should be inseminated at the usual
time following detection of estrus. If estrus detection is not
desirable or possible, treat
                                
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