ESTROPLAN - cloprostenol sodium injection, solution
Agri Laboratories, Ltd.
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Prostaglandin Analogue For Cattle
Equivalent to 250 mcg cloprostenol/mL
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION:
estroPLAN (cloprostenol sodium) injection is a synthetic prostaglandin analogue structurally related to prostaglandin F2α (PGF2α). 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 injection 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 injection 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
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 desirable or possible, treated animals may be inseminated twice at
about 72 and 96 hours post injection.
Pyometra Or Chronic Endometritis
Damage
to the reproductive tract at calving or post partum retention of the
placenta often leads to infection and inflammation of the uterus
(endometritis). Under certain circumstances, this may progress into
chronic endometritis with the uterus becoming distended with purulent
matter. This condition, commonly referred to as pyometra, is
characterized by a lack of cyclical estrus behavior and the presence of
a persistent corpus luteum. Induction of luteolysis with estroPLAN
usually results in evacuation of the uterus and a return to normal
cyclical activity within 14 days after treatment. After 14 days post
treatment, recovery rate of treated animals will not be different than
that of untreated cattle.
Mummified Fetus
Death
of the conceptus during gestation may be followed by its degeneration
and dehydration. Induction of luteolysis with estroPLAN usually results
in expulsion of the mummified fetus from the uterus. (Manual assistance
may be necessary to remove the fetus from the vagina.) Normal cyclical
activity usually follows.
Luteal Cysts
A
cow may be noncyclic due to the presence of a luteal cyst (a single,
anovulatory follicle with a thickened wall which is accompanied by no
external signs and by no changes in palpable consistency of the
uterus). Treatment with estroPLAN can restore normal ovarian activity
by causing regression of the luteal cyst.
Pregnancies From Mismating
Unwanted
pregnancies can be safely and efficiently terminated from 1 week after
mating until about five months of gestation. The induced abortion is
normally uncomplicated and the fetus and placenta are usually expelled
about four to five days after the injection with the reproductive tract
returning to normal soon after the abortion. The ability of estroPLAN
to induce abortion decreases beyond the fifth month of gestation while
the risk of dystocia and its consequences increases. estroPLAN has not
been sufficiently tested under feedlot conditions; therefore
recommendations cannot be made for its use in heifers placed in
feedlots.
1. Single estroPLAN Injection
Only
animals with a mature corpus luteum should be treated to obtain maximum
response to the single injection. However, not all cycling cattle
should be treated since a mature corpus luteum is present for only 11
to 12 days of the 21-day cycle.
Prior to treatment, cattle should
be examined rectally and found to be anatomically normal, be
non-pregnant and have a mature corpus luteum. If these criteria are
met, estrus is expected to occur two to five 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, treated animals may be
inseminated either once at about 72 hours or twice at about 72 and 96
hours post injection.
With a single injection program, it may be desirable to assess the cyclicity status of the herd before estroPLAN treatment. This can be accomplished by heat detecting and breeding at the usual time following detection of estrus for a 6-day period, all prior to injection. If by the sixth day the cyclicity status appears normal (approximately 25 - 30% detected in estrus), all cattle not already inseminated should be palpated for normality, non-pregnancy, and cyclicity, then injected with estroPLAN. Breeding should then be continued at the usual time following signs of estrus on the seventh and eighth day. On the ninth and tenth day breeding may continue at the usual time following detection of estrus or all cattle not already inseminated may be bred either once on the ninth day (at about 72 hours post injection) or on both the ninth and tenth day (at about 72 and 96 hours post injection).
2. Double estroPLAN Injections
Prior
to treatment, cattle should be examined rectally and found to be
anatomically normal, non-pregnant, and cycling (the presence of a
mature corpus luteum is not necessary when the first injection of a
double injection regimen is given). A second injection should be given
11 days after the first injection. In normal, cycling cattle, estrus is
expected 2 to 5 days following the second injection. Treated cattle
should be inseminated at the usual time following detection of estrus.
If estrus detection is not desirable or possible, treated animals may
be inseminated either once at about 72 hours or twice at about 72 and
96 hours following the second estroPLAN injection.
Many
animals will come into estrus following the first injection; these
animals can be inseminated at the usual time following detected estrus.
Animals not inseminated should receive a second injection 11 days after
the first injection. Animals receiving both injections may be
inseminated at the usual time following detection of estrus or may be
inseminated either once at about 72 hours or twice at about 72 and 96
hours post second injection.
Any controlled breeding program recommended should be completed by either:
REQUIREMENTS FOR CONTROLLED BREEDING PROGRAMS:
A
variety of programs can be designed to best meet the needs of
individual management systems. A controlled breeding program should be
selected which is appropriate for the existing circumstances and
management practices.
Before a controlled breeding program is planned the producer’s objectives must be examined and he must be made aware of the projected results and limitations. The producer and his consulting veterinarian should review the operation’s breeding history, herd health and nutritional status and agree that a controlled breeding program is practical in the producer’s specific situation. For any successful controlled breeding program:
- cows and heifers must be normal, nonpregnant, and cycling (rectal palpation should be performed).
- cattle must be in a fit and thrifty breeding condition and on an adequate or increasing plane of nutrition.
- proper program planning and record keeping are essential.
- if artificial insemination is being used it must be performed by competent inseminators using high quality semen.
It is important to understand that estroPLAN is effective only in animals with a mature corpus luteum (ovulation must have occurred at least 5 days prior to treatment). This must be considered when breeding is intended following a single estroPLAN injection.
SAFETY AND TOXICITY:
At 50 and 100 times the recommended dose, mild side effects may be detected in some cattle. These include increased uneasiness, slight frothing, and milk let-down.
CONTRAINDICATIONS:
estroPLAN should not be administered to a pregnant animal whose calf is not to be aborted.
WARNINGS:
For animal use only.
Women of child-bearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages women may be unaware of their pregnancies.
estroPLAN injection is readily absorbed through the skin and may cause abortion and/or bronchospasms: direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water.
PRECAUTIONS:
There is no effect on fertility following the single or double dosage regimen when breeding occurs at induced estrus or at 72 and 96 hours post treatment. Conception rates may be lower than expected in those fixed time breeding programs which omit the second insemination (i.e. the insemination at or near 96 hours). This is especially true if a fixed time insemination is used following a single estroPLAN injection.
As with all parenteral products, careful aseptic techniques should be employed to decrease the possibility of post injection bacterial infection. Antibiotic therapy should be employed at the first sign of infection.
DOSAGE AND ADMINISTRATION:
2mL of estroPLAN injection (500 mcg of cloprostenol) should be administered by INTRAMUSCULAR INJECTION for all indications in both beef and dairy cattle.
STORAGE CONDITIONS:
1. Protect from light.
2. Store in carton.
3. Store at controlled room temperature 20°-25°C (68°-77°F).
ANADA 200-310, approved by FDA
Made in Australia
Manufactured by:
Parnell Technologies Pty Ltd
4/476 Gardeners Road
Alexandria NSW 2015 Australia
Owner of the trademark estroPLAN
Distributed by:
Agri Laboratories, Ltd.
P.O. BOX 3103 St. Joseph, MO 64503
1.800.542.8916
www.agrilabs.com
An analogue of prostagandin F2α for intramuscular injection in beef and dairy cattle.
Equivalent to 250 mcg cloprostenol/mLCAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
FOR ANIMAL USE ONLY
20 mL 10 doses
ANADA 200-310, Approved by FDA
Distributed by: AgriLabs
Manufactured by: Parnell
Made in Australia
estroPLAN
(cloprostenol sodium)
injectionNDC 57561-009-02
Equivalent to 250 mcg cloprostenol/mL
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
100 mL 50 doses
ANADA 200-310, Approved by FDA
Made in Australia
Distributed by: AgriLabs
Manufactured by: ParnellestroPLAN
(cloprostenol sodium)
injection
NDC 57561-009-02
An analogue of prostagandin F2α for intramuscular injection in beef and dairy cattle.
Equivalent to 250 mcg cloprostenol/mL
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
FOR ANIMAL USE ONLY
100 mL 50 doses
ANADA 200-310, Approved by FDA
Distributed by: AgriLabs
Manufactured by: Parnell
Made in Australia
ESTROPLAN
cloprostenol sodium injection, solution |
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Labeler - Agri Laboratories, Ltd. (155594450) |