ESTROPLAN- cloprostenol sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Parnell Technologies Pty Ltd

INN (International Name):

cloprostenol sodium

Composition:

cloprostenol 250 ug in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Approved by FDA under ANADA # 200-310 estroPLAN (cloprostenol sodium) 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: estroPLAN (cloprostenol sodium) is a synthetic prostaglandin analogue structurally related to prostaglandin F2 α (PGF2 α ). 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: estroPLAN causes functional and morphological 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

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ESTROPLAN- CLOPROSTENOL SODIUM INJECTION, SOLUTION
PARNELL TECHNOLOGIES PTY LTD
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ESTROPLAN
Approved by FDA under ANADA # 200-310
ES TROPLAN
(CLOPROSTENOL SODIUM)
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:
estroPLAN (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:
estroPLAN causes functional and morphological 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
estroPLAN 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 NON-DETECTED ESTRUS
2α
2α
Cows which are not detected in estrus, although ovarian cyclicity
continues, can be treated with
estroPLAN 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
de