Severe localized post-injection clostridial infections have been reported; in rare instances infection has led to death. Copyright © 1995-2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. Classement du médicament en matière de délivrance : Liste I. À ne délivrer que sur ordonnance devant être conservée pendant au moins 5 ans.Respecter les doses prescrites. Gnrh to work properly should be given at least 10-13 days after known breeding. Each straw of semen contained circa 20 106 total sperm cells. USER SAFETY WARNINGS: Not for use in humans. Chez une jument qui n'a pas été vue en chaleur et chez laquelle un des ovaires présente un corps jaune présent depuis au moins 6 jours. Ne pas administrer aux femelles gestantes chez lesquelles l'induction de l'avortement ou de la parturition n'est pas désirée.Ne pas administrer chez les animaux présentant une maladie spastique du tractus respiratoire ou gastro-intestinal. A follicle is a structure containing an egg, also called an ovum, and other cells that can produce estrogen. Une attention particulière devra être apportée à la manipulation du produit afin d'éviter tout risque d'auto-injection ou de contact avec la peau.Les femmes enceintes, les femmes en âge de procréer, les asthmatiques ou les personnes présentant des maladies respiratoires ne doivent pas manipuler le cloprosténol.En cas d'aspersion accidentelle sur la peau, laver immédiatement la zone contaminée avec de l'eau et du savon.En cas d'auto-injection accidentelle, demander immédiatement conseil à un médecin et lui montrer la notice ou l'étiquette du produit. Note: Some of the above drugs may be marketed with a different trade name (also known as the proprietary name) under what’s called “distributor labeling.”. Side effects of PG's include: often causes profuse sweating, increased heart rate and respiratory rate, abdominal discomfort, locomotor incoordination and lying down. (dose range 1,500 to 3,000 IU), hCG stimulation test to evaluate horse for presence of testicular tissue (testosterone response test), Gonadotropin releasing hormone (GnRH) - native, 500 µg, IV or IM, once, 1 to 2 hours prior to breeding or collection, Increase libido in stallions with low libido, 20 units, IV or IM, q 6h to q 24h or as needed, Stimulation of uterine contractions (evacuation of uterine fluid), treatment of retained placenta, milk let-down, Induction of labor; administer 5 units followed by 10 units 15 minutes later; a majority of full term mares will rupture their chorioallantoic membrane within 5 to 15 minutes after the second dose of oxytocin, Progesterone-in-oil (P4) (50 or 100 mg/ml), Suppression of behavioral estrus; synchronization of estrus and ovulation, Synchronization of estrus, ‘programming’ time of ovulation in transitional mares, suppression of estrus, 1,000 to 2,000 µg, topically onto cervix and within cervical lumen, as needed, Cervical relaxation; tablets are crushed and added to DMSO gel or sterile obstetrical gel and applied to the surface and lumen of the cervix, Prostaglandin E2 (dinoprostone cervical gel; Prepidil Gel, 1.0 mls gel applied to surface of each oviduct, Applied to surface of oviducts via laparoscope to ‘unblock’ oviducts suspected of luminal blockage with gelatinous masses that contain fibroblast cells, Dopamine antagonist; stimulation of lactation in postpartum mares; induction of lactation in nonpregnant mares; stimulation of follicular development in transitional mares. Normal cyclical activity usually follows. To obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Merck Animal Health at 1-800-211-3573 or http://www.merck.com. For treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers, 5. Il peut s'agir de juments chez lesquelles les chaleurs sont passées inaperçues (subœstrus), de juments porteuses d'un embryon mort ou, enfin . Conception rates may be lower than expected in those fixed time breeding programs employing Estrumate alone which omit the second insemination (ie, the insemination at or near 96 hours). Set id: 634a706f-4a00-4a04-86ae-a4d8c22b8271, For unobserved or non-detected estrus in beef cows, lactating dairy cows, and replacement beef and dairy heifers, For treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers, For treatment of mummified fetus in beef cows, lactating dairy cows, and replacement beef and dairy heifers, For treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers, For abortion of beef cows, lactating dairy cows, and replacement beef and dairy heifers, For estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers, (gonadorelin) to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows, Single Estrumate injection: Only animals with a mature, Double Estrumate injections: prior to treatment, cattle should be examined rectally and found to be anatomically normal, nonpregnant, and cycling (the presence of a mature, observing animals (especially during the third week after injection) and inseminating or hand mating any animals returning to estrus, or. A sterile solution of a prostaglandin F2α analogue for intramuscular injection in beef cows, lactating dairy cows, and replacement beef and dairy heifers. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=634a706f-4a00-4a04-86ae-a4d8c22b8271, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. To reduce the risk of anaerobic infections care should be taken to avoid injection through contaminated areas of skin. - Interruption de gestations normales non désirées :Administrer le médicament au plus tôt 7 jours après la saillie et au plus tard au 150e jour de gestation. Pregnant animals may abort depending on the stage of gestation. ESTRUMATE alone will not increase fertility. Accidental spillage on the skin should be washed off immediately with soap and water. A heifer or cow will generally have two or three groups of ovarian follicles—called waves—develop during a single estrous cycle (the range is one to four waves). Prescription animal drugs must be used by or on the order of a licensed veterinarian. (Bayley 1999) Anthelmintics. The site is secure. this version. 0061-5995-02, For unobserved or non-detected estrus in beef cows, lactating dairy cows, and replacement beef and dairy heifers, For treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers, For treatment of mummified fetus in beef cows, lactating dairy cows, and replacement beef and dairy heifers, For treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers, For abortion of beef cows, lactating dairy cows, and replacement beef and dairy heifers, For estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers, (gonadorelin) to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows, All Drug Files, All Mapping cows and heifers must be normal, non-pregnant, and cycling (rectal palpation should be performed); cows and heifers must be in sound breeding condition and on an adequate or increasing plane of nutrition; proper program planning and record keeping are essential; if artificial insemination is used, it must be performed by competent inseminators using high-quality semen. Chez la jument :0,25 mg (250 μg) à 0,5 mg (500 μg) de cloprosténol (sous forme de sel de sodium) par jument, soit :- Race légère : 1 mL de solution par voie intramusculaire- Race lourde : 2 mL de solution par voie intramusculaire. One follicle in each wave will become the dominant follicle. To obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Merck Animal Health at 1-800-211-3573 or http://www.merck.com. Estrumate (clopostenol) 250 μg, IM or SQ. The producer and the consulting veterinarian should review the operation's breeding history, herd health, and nutritional status and agree that a breeding program is practical in the producer's specific situation. Treated animals should be closely observed post injection and appropriate antibiotic therapy initiated at the first sign(s) of infection. Prostaglandin. Les animaux seront inséminés sur chaleurs observées ou deux fois 72 et 96 heures après la seconde administration. Do not use this drug product in pregnant cattle, unless abortion is desired. For treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers, 3. Estrumate® (cloprostenol injection) is a synthetic prostaglandin analogue structurally related to prostaglandin F2 α (PGF2 α). ESTRUMATE® is a registered trademark of Intervet Inc. Used under license. View NDC Code(s)NEW! Gestation (the period between when the animal becomes pregnant and when she calves) lasts about 283 days. Updated It is important to understand that Estrumate is effective only in animals with a mature corpus luteum (ovulation must have occurred at least 5 days prior to treatment). During this phase, there is rapid growth of a dominant ovarian follicle and increased estrogen production. Controlled breeding: The luteolytic action of ESTRUMATE can be used to schedule estrus and ovulation for an individual animal or a group of animals. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval; The manufacturing process to ensure quality and consistency are maintained from batch to batch; The drug’s labeling to make sure the information remains truthful, complete, and not misleading; and. Estrumate® (cloprostenol sodium) is a synthetic prostaglandin analogue structurally related to prostaglandin F2α (PGF2α). $129.95. Il peut être nécessaire de retirer manuellement le foetus qui resterait bloqué dans le vagin. Copy the URL below and paste it into your RSS Reader application. turning in clean-up bull(s) 5 to 7 days after the last injection of Estrumate to cover any animals returning to estrus. Better luteolysis is related to better conception. Heifers fed an appropriate diet will generally reach puberty between 9 and 15 months of age. Estrumate® (cloprostenol injection) is a synthetic prostaglandin analogue structurally related to prostaglandin F2 α (PGF2 α). Instead, she's "anestrus," which is sometimes described as being “acyclic.” Right after a heifer or cow calves, it’s normal for her to be anestrus for a short period of time. Intervet Canada Corp., subsidiary of Merck & Co., Inc., 16750, route Transcanadienne, Kirkland, QC H9H 4M7. The high progesterone level stops the heifer or cow from cycling—she won’t go into heat or ovulate. Estrumate® (cloprostenol injection) is a synthetic prostaglandin analogue structurally related to prostaglandin F2 α (PGF2 α). Si les chaleurs n’ont pas été observées suite à la première injection, il est nécessaire de pratiquer une seconde injection 11 jours après la première. The FOI Summary for the supplemental approval of ANADA 200-134 (under section 512(b)(1) of the FD&C Act) dated April 23, 2015, contains a summary of studies that demonstrate effectiveness of Fertagyl ® (gonadorelin) for use with Estrumate ® Approved by FDA under NADA # 113-645Copyright © 2017 Intervet Inc (d/b/a Merck Animal Health) a subsidiary of Merck & Co., Inc. Madison, NJ 07940 All rights reserved.Made in Germany. Après injection intramusculaire chez la vache, le cloprosténol est rapidement résorbé avec des pics de concentration généralement atteints dans les 15 premières minutes. Treatment of pyometra or chronic endometritis. To report suspected adverse drug experiences, call Merck Animal Health at 1-800-211-3573. Use only with automatic injection equipment or repeater syringe. The company must show that the drug can be consistently produced from batch to batch; and. Administer the second Fertagyl injection (2 mL) 30 to 72 hours after the Estrumate injection. The company’s marketing communications related to the drug to make sure the information is truthful and not misleading. ● Cattle should be in good condition for breeding. For example, a cow is normally anestrus after giving birth, and an estrous synchrony regimen may be used to advance her first heat after calving. 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. Under the influence of high progesterone, waves of follicles continue to emerge and regress without a dominant ovarian follicle rupturing. Instead, it will grow larger and produce increasingly more estrogen. This product should be handled carefully to avoid accidental self-injection or contact with the skin or mucous membranes of the user. When a heifer or cow has an estrous cycle that’s normal in length and she displays normal estrous behaviors during heat, she’s said to be "cycling." A good understanding of the normal estrous cycle in cattle can help producers address reproductive challenges in both heifers (young female dairy or beef animals that have not yet had their first calf) and cows (female dairy or beef animals that have had at least one calf). Estrumate causes functional and morphological regression of the corpus luteum (luteolysis) in cattle. Accidental spillage on the skin should be washed off immediately with soap and water. 7. Citations, PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton, (What A heifer has her first estrus, or heat, at puberty. A portion of a bovine norgestomet ear implant (1.5 mg/goat) or injection of progesterone in oil (10 mg/day, IM) has also been effective. Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the cycling animal there are refractory periods of 4 to 5 days before and after ovulation when cattle are not responding to prostaglandin. Dosage: 2ml Intramuscular. A dominant follicle won’t rupture again until the progesterone level falls during the next follicular phase. Normal cyclical activity should then follow.). For that to happen, the heifer must reach puberty and become pregnant by 14 to 15 months of age. USER SAFETY WARNINGS: Not for use in humans. Direct contact with the skin should therefore be avoided. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Une infection anaérobie peut survenir en cas de pénétration de bactéries anaérobies au site d'injection, en particulier suite à l'injection intramusculaire.Dans le cadre de l'induction de la parturition, en fonction de la date de traitement par rapport à la date de conception, l'incidence de rétention placentaire peut être augmentée.Dans de très rares cas, des réactions de type anaphylactique peuvent être observées, nécessitant des soins médicaux immédiats. The ability of Estrumate to induce abortion decreases beyond the fifth month of gestation while the risk of dystocia and its consequences increases. Drugs in the progestin class act similar to the hormone progesterone naturally secreted by the corpus luteum. Two mL of Estrumate (500 mcg cloprostenol) should be administered by INTRAMUSCULAR INJECTION using the specific dosage regimen for the indication. (Ponies and donkeys: single dose of 0.5-1.0 ml (equivalent to 125-250 mcg of cloprostenol) by intramuscular injection. When a heifer or cow isn’t pregnant but she’s not ovulating or showing signs of heat, she’s not cycling. Use in well ventilated areas and avoid inhalation and contact with eyes. 1 This essential reproductive tool allows for better heat detection and increased control of breeding and calving intervals. concentration 250mcg/ml cloprostenol. Dewormers such as the ivermectins (e.g., Eqvalan®) are powerful chemicals and are commonly used with horses. On the ninth and tenth days, 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 days (at about 72 and 96 hours post-injection). Accidental spillage on the skin should be washed off immediately with water. Protect from freezing. 1. The drug’s labeling is truthful, complete, and not misleading. Two mL of Estrumate (500 mcg cloprostenol) should be administered by INTRAMUSCULAR INJECTION using the specific dosage regimen for the indication. The induced abortion is normally uncomplicated and the fetus and placenta are usually expelled about 4 to 5 days after the injection with the reproductive tract returning to normal soon after the abortion. - Élimination de foetus momifiés : Après administration du médicament, l'expulsion du foetus est observée dans un délai de 3 à 4 jours. Causes the regression of the corpus luteum in beef and dairy cattle. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Cloprostenol is a synthetic analogue of prostaglandin F 2α (PGF 2α ). Pregnant animals may abort depending on the stage of gestation. 100 mL bottle size: Use within 28 days of first puncture and puncture a maximum of 12 times. Estrumate causes functional and morphological regression of the corpus luteum (luteolysis) in cattle. ESTRUMATE cloprostenol is a synthetic prostaglandin analogue, structurally related to prostaglandin F 2 (PGF 2 ). 2European Agency for the Evaluation of Medicinal Products, Committee for Veterinary Medicinal Products, Cloprostenol and R-Cloprostenol Summary Report, 1997. Un œstrus fertile doit se produire après 3 à 4 jours. For estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers. If the egg isn’t fertilized or the early embryo fails to develop, the uterus releases the hormone prostaglandin F2-alpha around Days 16 to 20 of the estrous cycle. ESTRUMATE injection for cattle is the top cloprostenol on the market, proven to improve reproductive performance in both dairy and beef cattle. Contents should be used within 28 days after the first dose is removed. To report suspected adverse drug experiences, call Merck Animal Health at 1-800-211-3573. It may also be used to terminate pregnancies resulting from mismatings and to treat certain conditions associated with prolonged luteal function. The dominant follicle produces enough estrogen to cause estrus, thus starting the next estrous cycle. Use in reproductive synchrony programs similar to the following: • Administer the first Fertagyl® injection (2 mL; 86 mcg gonadorelin, as gonadorelin acetate) by intramuscular injection on Day 0. After puberty, a heifer continues to have regular estrous cycles every 21 days (the normal range is every 18 to 24 days). For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or at http://www.fda.gov/reportanimalae. In rare instances, such infections have resulted in death. 20 mL bottle size . Do not use this drug product in pregnant cattle, unless abortion is desired. This condition can be successfully treated by causing regression of the C.L. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 1 Senger PL. These include increased uneasiness, mild transient diarrhea, slight frothing and milk letdown. (Figure used with permission from Current Conceptions, Inc. from Pathways to Pregnancy and Parturition, 3rd ed.1 Image cannot be reprinted in any other publication in hard copy or electronic form without written permission from Current Conceptions, Inc.), The Follicular Phase: Waves of Ovarian Follicles. Merck Sharp & Dohme Corp. 250 mcg cloprostenol/mL (equivalent to 263 mcg cloprostenol sodium/mL), A sterile solution of a prostaglandin F2α analogue for intramuscular injection in beef cows, lactating dairy cows, and replacement beef and dairy heifers. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Early in the estrous cycle, when the progesterone level is high, the dominant follicle will not ovulate. Estrumate can be used in a breeding program with the following methods: • Single Estrumate injection: Only animals with a mature corpus luteum should be treated to obtain maximum response to the single injection. Damage to the reproductive tract at calving or postpartum retention of the placenta often leads to infection and inflammation of the uterus (endometritis). Prior to treatment, cattle should be examined rectally and found to be anatomically normal, be non-pregnant, and have a mature corpus luteum. Clean and disinfect injection sites thoroughly before application. 100 mL bottle size: Use within 28 days of first puncture and puncture a maximum of 12 times. Direction and dosage information for Estrumate. Cattle should be palpated. The semen of each bull was collected in a single ejaculate and was divided equally among treatment groups.

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