[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$f374v12wvlfdfu":5},{"data":4},[],{"data":6,"error":10},{"id":7,"documentId":8,"slug":9,"name":9,"proprietary_name":10,"non_proprietary_name":10,"is_proprietary":10,"active_ingredient":10,"administration_route":10,"available_strength":10,"dosage_form":10,"dose_schedule":10,"drug_unit":10,"is_available_generically":10,"mechanism_of_action":10,"overdosage":10,"warning":10,"species":11,"citations":12,"dose_schedules":23,"available_strengths":91,"label_statements":115,"drug_classes":211,"specialties":217,"medical_conditions":218,"animal_species":219},1849,"ctvdwuydto64xl6gm6rwqodt","altrenogest",null,[],[13,19],{"source":14,"licence":15,"source_url":16,"harvested_by":17,"retrieved_at":18},"FDA Green Book","US public domain","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002FingredientsInformationExcel\u002FSection2ActiveIngredients","load-reference-corpus.cjs","2026-09-07",{"source":20,"licence":21,"source_url":22,"harvested_by":17,"retrieved_at":18},"UK VMD PID","OGL v3.0","https:\u002F\u002Fwww.vmd.defra.gov.uk\u002Fproductinformationdatabase\u002Fdownloads\u002Fvmd_productinformationdatabase.xlsx",[24,30,35,39,43,47,51,55,58,63,66,71,74,80,85],{"id":25,"dose_text":26,"species":27,"administration_route":28,"limitation":10,"source_label":29},13650,"While wearing vinyl, neoprene, or nitrile gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. This product can penetrate latex or other types of porous gloves. Latex gloves are not protective. Connect the MATRIX® Dosing Device to the solution bottle, according to the instructions provided with the MATRIX® Dosing Device. Do not use any dosing device other than the MATRIX® Dosing Device. Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days. Treat gilts on an individual animal basis by top-dressing MATRIX® on a portion of each gilt's daily feed allowance. To produce the desired synchronization of estrus in a group of gilts, treat all of the gilts daily for the same 14-day period.","Swine (Mature Gilts)","Oral","Matrix®",{"id":31,"dose_text":32,"species":10,"administration_route":33,"limitation":10,"source_label":34},13651,"DOSAGE AND ADMINISTRATION:\nAdminister solution orally at the rate of 1 mL per 110 pounds body weight (0.044 mg\u002Fkg) once daily for 15 consecutive days. Administer solution directly on the base of the mare’s tongue or on the mare’s usual grain ration.\nDOSAGE CHART:\nApproximate Weight in Pounds\nDose in mL\n770\n7\n880\n8\n990\n9\n1100\n10\n1210\n11\n1320\n12\nWhen handing OvaMed product or syringe, always use vinyl, neoprene, or nitrile gloves. Latex gloves are not protective. This product may be dosed using a luer lock syringe.\nFor use with a luer lock syringe, remove shipping cap and seal; replace with enclosed plastic dispensing cap. Remove cover from bottle dispensing tip and connect luer lock syringe (without needle). Draw out appropriate volume of OvaMed solution and return bottle to upright position before detaching syringe. (Note: Do not remove syringe while bottle is inverted as spillage may result.) Replace cover on bottle dispensing tip to prevent leakage. Syringes used for administration should be replaced frequently and disposed of in a secure manner to prevent exposure to the product.\nWhich Mares Will Respond to OvaMed: Extensive clinical trials have demonstrated that estrus will be suppressed in approximately 95% of the mares within three days; however, the post-treatment response depended on the level of ovarian activity when treatment was initiated. Estrus in mares exhibiting regular estrus cycles during the breeding season will be suppressed during treatment; these mares return to estrus four to five days following treatment and continue to cycle normally. Mares in winter anestrus with small follicles continued in anestrus and failed to exhibit normal estrus following withdrawal.\nResponse in mares in the transition phase between winter anestrus and the summer breeding season depended on the degree of follicular activity. Mares with inactive ovaries and small follicles failed to respond with normal cycles post-treatment, whereas a higher proportion of mares with ovarian follicles 20 mm or greater in diameter exhibited normal estrus cycles post-treatment. Altrenogest solution 0.22% was very effective for suppressing the prolonged estrus behavior frequently observed in mares during the transition period (February, March, and April). In addition, a high proportion of these mares responded with regular estrus cycles post-treatment\nSpecific Uses for OvaMed:\n1. Suppression of estrus to facilitate attainment of regular cycles during the transition period from winter anestrus to the physiological breeding season. To facilitate attainment of regular cycles during the transition phase, mares should be examined to determine the degree of ovarian activity. Estrus in mares with inactive ovaries (no follicles greater than 20 mm in diameter) will be suppressed, but these mares may not begin regular cycles following treatment. However, mares with active ovaries (follicles greater than 20 mm in diameter) frequently respond with regular post-treatment estrus cycles.\n2. Suppression of estrus to facilitate management of the mare exhibiting prolonged estrus during the transition period. Estrus will be suppressed in mares exhibiting prolonged behavioral estrus either early or late during the transition period. Again, the post-treatment response depends on the level of ovarian activity. The mares with greater ovarian activity initiate regular cycles and conceive sooner than the inactive mares. OvaMed (altrenogest) may be administered early in the transition period to suppress estrus in mares with inactive ovaries to aid in the management of these mares or to mares later in the transition period with active ovaries to prepare and schedule the mare, for breeding.\n3. Suppression of estrus to permit scheduled breeding of mares during the physiological breeding season. To permit scheduled breeding, mares which are regularly cycling or which have active ovarian function should be given OvaMed (altrenogest) daily for 15 consecutive days beginning 20 days before the date of the planned estrus. Ovulation will occur 5 to 7 days following the onset of estrus as expected for non-treated mares. Breeding should follow usual procedures for mares in estrus. Mares may be regulated and scheduled either individually or in groups.","ORAL","FDA application 200-481",{"id":36,"dose_text":37,"species":10,"administration_route":33,"limitation":10,"source_label":38},13652,"DOSAGE AND ADMINISTRATION:\nAdminister solution orally at the rate of 1 mL per 110 pounds body weight (0.044 mg\u002Fkg) once daily for 15 consecutive days. Administer solution directly on the base of the mare's tongue or on the mare's usual grain ration.\nDosage Chart\nApproximate Weight (Pounds)\nDose in mL\n770\n7\n880\n8\n990\n9\n1100\n10\n1210\n11\n1320\n12\nWhen handling Regu-Mate® product, the dosing device, or syringes, always use vinyl, neoprene, or nitrile gloves. Latex gloves are not protective. The product may be dosed using Regu-Mate® Equine Dosing Device or a luer lock syringe. Use of the Regu-Mate® Equine Dosing Device is recommended to reduce the risk of human exposure. Follow all instructions when using the dosing device. Do not use any dosing device other than the Regu-Mate® Equine Dosing Device.\nFor use with Regu-Mate® Equine Dosing Device, first assemble the device according to directions supplied with the Regu-Mate Equine Dosing Device. Remove the shipping cap and seal on Regu-Mate (altrenogest) bottle. Store the cap in a clean and dry location. Apply downward force and fasten the quick connect cap with dip tube onto the product bottle. The flexible dip tube will contact the bottom of the product bottle and bend slightly. Turn the dose selection dial to 15. Hold the dosing device vertically with the nozzle on the top. Direct the opening of the nozzle away from any person and cover it with absorbent material. Slowly squeeze and release handle until air in the barrel is expelled and product starts to come out. Prime the device by expelling two (2) doses of 15 mL of product into a waste container or absorbent material. (Re-prime the dosing device by expelling two (2) doses if air is observed inside the barrel after switching to a fresh bottle or during dosing period). Set the dose according to DOSAGE CHART provided herein by turning the dose selection dial. The dosing device is ready for use. Refer to the Regu-Mate® Equine Dosing Device label for equipment cleaning instructions.\nFor use with a luer lock syringe, remove shipping cap and seal; replace with enclosed plastic dispensing cap. Remove cover from bottle dispensing tip and connect luer lock syringe (without needle). Draw out appropriate volume of Regu-Mate® solution and return bottle to upright position before detaching syringe. (Note: Do not remove syringe while bottle is inverted as spillage may result.) Replace cover on bottle dispensing tip to prevent leakage. Syringes used for administration should be replaced frequently and disposed of in a secure manner to prevent exposure to the product.","Regu-Mate® (altrenogest)",{"id":40,"dose_text":41,"species":10,"administration_route":33,"limitation":10,"source_label":42},13653,"For oral administration.\nAdminister 1 mL MATE per 50 kg bodyweight (equivalent to 0.044 mg altrenogest per kg) daily.\n1. Regulation and control of the breeding cycle of mares\na. For the induction of ovulatory oestrus or to induce cyclical ovarian activity in mares with some follicle activity early in the breeding season: Administer MATE daily for 10 consecutive days.\nb. For the suppression of oestrus in normally cycling mares: Administer MATE daily for 15 consecutive days. For the suppression of prolonged oestrus: Administer MATE daily for 10 consecutive days.\nc. To control the breeding cycle of mares to allow efficient use of the stallion: Administer MATE daily for 15 consecutive days.\n2. For the treatment of habitually aborting mares, or mares at risk of early embryonic death or abortion: Administer MATE daily, from the 2nd or 3rd day after ovulation in the mated or inseminated mare, continuing until day 120 of gestation.\nNOTE: Ultrasound scanning to confirm pregnancy is recommended on day 14 or 15 after ovulation. If the mare is not pregnant, it is advised to cease MATE administration and to administer an injection of prostaglandin F2α to destroy any luteal tissue that may be still present, allowing the mare to return to oestrus and be re-mated.\nMEAT WITHHOLDING PERIODS (HORSES)\nDO NOT USE less than 28 days before slaughter for human consumption.","Mate Oral Progestagen for Horses",{"id":44,"dose_text":45,"species":10,"administration_route":33,"limitation":10,"source_label":46},13654,"For use with a luer lock syringe, remove shipping cap and seal; replace with enclosed plastic dispensing cap. Remove cover from bottle dispensing tip and connect luer lock syringe (without needle). Draw out appropriate volume of Altren® solution and return bottle to upright postition before detaching syringe. (Note: Do not remove syringe while bottle is inverted as spillage may result.) Replace cover on bottle dispensing tip to prevent leakage. Syringes used for administration should be replaced frequently and disposed of in a secure manner to prevent exposure to product.","ALTREN® (altrenogest)",{"id":48,"dose_text":49,"species":10,"administration_route":33,"limitation":10,"source_label":50},13655,"While wearing vinyl, neoprene, or nitrile gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. This product can penetrate latex or other types of porous gloves. Latex gloves are not protective. Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days. Treat gilts on an individual animal basis by top-dressing SwineMate® on a portion of each gilt’s daily feed allowance. To produce the desired synchronization of estrus in a group of gilts, treat all of the gilts daily for the same 14-day period.","SwineMate® (altrenogest)",{"id":52,"dose_text":53,"species":10,"administration_route":33,"limitation":10,"source_label":54},13656,"Horses: Administer orally at the rate of 1 ml per 50kg (110 lbs) body weight (0.044mg\u002Fkg) once daily for 15 consecutive days. Administer orally by dose syringe or suitable plastic syringe on to the posterior-dorsal surface of the tongue. The recommended dose may alternatively be added to the usual ration.\nDosage Chart:\nApproximate Weight\nDose\nin Pounds\nin mL\n770\n7\n880\n8\n990\n9\n1100\n10\n1210\n11\n1320\n12","Altren® Solution 0.22% (altrenogest)",{"id":56,"dose_text":57,"species":10,"administration_route":33,"limitation":10,"source_label":46},13657,"Administer solution orally at the rate of 1 mL per 110 pounds of body weight (0.044 mg\u002Fkg) once daily for 15 consecutive days. Administer solution directly on the base of the mare’s tongue or on the mare’s usual grain ration.",{"id":59,"dose_text":60,"species":10,"administration_route":28,"limitation":61,"source_label":62},13658,"administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days. Treat gilts on an individual animal basis by top dressing Altrenogest Solution on a portion of each gilt’s daily feed allowance","Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis). Gilts must not be slaughtered for human consumption for 21 days after the last treatment","ChronoMate™",{"id":64,"dose_text":65,"species":10,"administration_route":33,"limitation":10,"source_label":54},13659,"Swine: Top dress on gilts daily ration at the rate of 15mg of altrenogest per gilt per day for 14 consecutive days. The recommended daily dose represents 6.8 mL of the 0.22% solution.",{"id":67,"dose_text":68,"species":10,"administration_route":28,"limitation":69,"source_label":70},13660,"Administer orally at the rate of 1 milliliter per 110 pounds body weight (0.044 milligram per kilogram body weight). Give one dose daily for 15 consecutive days.","Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.","Regu-Mate®",{"id":72,"dose_text":73,"species":10,"administration_route":33,"limitation":10,"source_label":46},13661,"Approximate Weight\nDose\nin Pounds\nin mL\n770\n7\n880\n8\n990\n9\n1100\n10\n1210\n11\n1320\n12",{"id":75,"dose_text":76,"species":77,"administration_route":28,"limitation":78,"source_label":79},13662,"Administer orally at a rate of 1 mL per 110 lbs body weight (0.044 mg\u002Fkg) once daily for 15 consecutive days.","Horses (Mares)","Do not use in horses intended for human consumption.","OvaMed®",{"id":81,"dose_text":82,"species":83,"administration_route":28,"limitation":69,"source_label":84},13663,"Administer solution orally at the rate of 1.0 mL per 110 pounds body weight (0.044 mg\u002Fkg) daily for 15 consecutive days.","Horses (mares)","Altren®",{"id":86,"dose_text":87,"species":88,"administration_route":28,"limitation":89,"source_label":90},13664,"Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days. Treat gilts on an individual animal basis by top dressing SwineMate® on a portion of each gilt’s daily feed allowance. To produce the desired synchronization of estrus in a group of gilts, treat all of the gilts daily for the same 14-day period.","Swine (gilts)","Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis).","SwineMate®",[92,96,100,104,107,110,112],{"id":93,"strength_text":94,"dosage_form":95,"proprietary_name":29,"species":27,"source_label":29},11876,"2.2 mg altrenogest per mL (0.22%)","Oral Solution",{"id":97,"strength_text":98,"dosage_form":99,"proprietary_name":70,"species":10,"source_label":70},11877,"Each milliliter of altrenogest solution contains 2.2 milligrams of altrenogest.","Liquid (Solution)",{"id":101,"strength_text":102,"dosage_form":103,"proprietary_name":79,"species":77,"source_label":79},11878,"Each milliliter solution contains 2.2 milligrams of altrenogest.","Solution",{"id":105,"strength_text":106,"dosage_form":95,"proprietary_name":62,"species":10,"source_label":62},11879,"0.22% (2.2 mg\u002FmL)",{"id":108,"strength_text":109,"dosage_form":103,"proprietary_name":84,"species":83,"source_label":84},11880,"2.2 mg\u002FmL",{"id":111,"strength_text":109,"dosage_form":103,"proprietary_name":90,"species":88,"source_label":90},11881,{"id":113,"strength_text":114,"dosage_form":10,"proprietary_name":10,"species":10,"source_label":42},11882,"2.2 mg \u002F 1 mL",[116,120,123,126,129,132,135,138,142,145,147,149,152,156,159,162,165,169,172,175,178,181,184,187,190,193,196,199,202,205,208],{"id":117,"kind":118,"statement":119,"species":27,"limitation":10,"source_label":29},20008,"indication","For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle. Treatment with MATRIX® results in estrus (standing heat) 4 to 9 days after completion of the 14-daytreatment period. It is a violation of Federal law to use this drug product other than as directed in the labeling or as directed by your veterinarian.",{"id":121,"kind":118,"statement":122,"species":10,"limitation":10,"source_label":54},20009,"Horses: Suppression of estrus to:\n1. Facilitate attainment of regular cycles during the transition period from winter anestrus to the physiological breeding season.\nTo facilitate the attainment of regular cycles during the transition phase, mares should be examined to determine the degree of ovarian activity. Estrus in mares with inactive ovaries (no follicles greater than 20 mm in diameter) will be suppressed but these mares may not begin regular cycles following treatment. However, mares with active ovaries (follicles greater than 20 mm in diameter) frequently respond with regular post-treatment estrus cycles.\n2. Facilitate management of the mares exhibiting prolonged estrus during the transition period. Estrus will be suppressed in mares exhibiting prolonged behavioural estrus either early or later during the transition period. Again, the post-treatment response depends upon the level of ovarian activity. The mares with greater ovarian activity initiate regular cycles and conceive sooner than the inactive mares. Altren® Solution 0.22% may be administered early in the transition period to suppress estrus in mares with inactive ovaries to aid in the management of these mares or to mares later in the transition period with active ovaries to prepare and schedule the mare for breeding.\n3. Permit scheduled breeding of mares during the physiological breeding season. To permit scheduled breeding, mares which are regularly cycling or which have active ovarian function should be given Altren® Solution 0.22% daily for 15 consecutive days, beginning 20 days before the date of the planned estrus. Ovulation will occur 5 to 7 days following the onset of estrus as expected for non- treated mares. Breeding should follow usual procedures for mares in estrus. Mares may be regulated and scheduled either individually or in groups.",{"id":124,"kind":118,"statement":125,"species":10,"limitation":10,"source_label":54},20010,"Horses: Altren® Solution 0.22% is indicated for suppression of estrus. Suppression of estrus allows for a predictable occurrence of estrus following drug withdrawal. This facilitates the attainment of regular cyclicity during the transition from winter anestrus to the physiological breeding season. Suppression of estrus will also facilitate management of prolonged estrus conditions. Suppression of estrus may be used to facilitate scheduled breeding during the physiological breeding season.\nSwine: Altren® Solution 0.22% is indicated for suppression of estrus in sexually mature gilts.\nAltren® Solution 0.22% mimics the action of progesterone and blocks the cyclical release of gonadotrophins and thus the development of estrus. Following cessation of\ntreatment, pituitary inhibition ceases and normal development and maturation of the follicles returns, leading to a return to estrus and ovulation. The predictable return to estrus (generally 5-7 days following cessation of treatment) allows for estrus synchronization in a pool of cycling gilts.\nAltren® Solution 0.22% is indicated for suppression of estrus in sexually mature gilts to:\n1. Permit synchronization of estrus in cycling gilts.\n2. Improve breeding unit organization by facilitating batch management (all in, all out system) of the breeding gilts.\n3. Reduce the pre-breeding gilt pool size.",{"id":127,"kind":118,"statement":128,"species":10,"limitation":10,"source_label":42},20011,"For regulation and control of the breeding cycle of mares\n• To induce ovulatory oestrus early in the breeding season in mares where some follicular activity exists\n• For the suppression of oestrus either during prolonged oestrus or in normally cycling mares\n• For the control of the ovarian cycle in breeding mares to allow the most efficient use of the stallion\nFor the maintenance of pregnancy in habitually aborting mares, or mares at risk of early embryonic death or abortion, where progesterone deficiency is thought to be the underlying cause.",{"id":130,"kind":118,"statement":131,"species":10,"limitation":10,"source_label":34},20012,"INDICATIONS:\nFor suppression of estrus in mares. Suppression of estrus allows for a predictable occurrence of estrus following drug withdrawal. This facilitates the attainment of regular cyclicity during the transition from winter anestrus to the physiological breeding season. Suppression of estrus will also facilitate management of prolonged estrus conditions. Suppression of estrus may be used to facilitate scheduled breeding during the physiological breeding season.",{"id":133,"kind":118,"statement":134,"species":10,"limitation":10,"source_label":50},20013,"For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle. Treatment with SwineMate® results in estrus (standing heat) 4 to 9 days after completion of the 14-day treatment period.\nIt is a violation of Federal law to use this drug product other than as directed in the labeling or as directed by your veterinarian.",{"id":136,"kind":118,"statement":137,"species":10,"limitation":61,"source_label":62},20014,"for synchronization of estrus in sexually mature gilts that have had at least one estrus cycle. Treatment with altrenogest solution 0.22% results in estrus (standing heat) 4 to 9 days after completion of the 14-day treatment period",{"id":139,"kind":118,"statement":140,"species":10,"limitation":10,"source_label":141},20015,"Oral solution, 2.2 mg altrenogest per mL (0.22%) Synthetic progestin\nFor Use in Swine Only","MATRIX® (altrenogest)",{"id":143,"kind":118,"statement":144,"species":10,"limitation":69,"source_label":70},20016,"For suppression of estrus in mares.",{"id":146,"kind":118,"statement":144,"species":77,"limitation":78,"source_label":79},20017,{"id":148,"kind":118,"statement":144,"species":83,"limitation":69,"source_label":84},20018,{"id":150,"kind":118,"statement":151,"species":88,"limitation":89,"source_label":90},20019,"For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.",{"id":153,"kind":154,"statement":155,"species":10,"limitation":10,"source_label":54},20020,"contraindication","Horses: Altren® Solution 0.22% is contraindicated in pregnant mares and in mares having a previous history of uterine inflammation (i.e. a Grade II or greater uterine biopsy result), or current uterine inflammations (i.e. acute, subacute or chronic endometritis). Altren® Solution 0.22% therapy may exacerbate an existing uterine inflammation into a fulminating uterine inflammation. The safety of this drug in pregnant mares has not been established. Various synthetic progestins, including altrenogest, when administered to rats during the embryonic stage of pregnancy at doses many fold greater than the recommended equine dose caused foetal anomalies, specifically of the female genitalia.\nSwine: Altren® Solution 0.22% is contraindicated in gestating gilts or sows and is not to be administered to breeding boars since it could interfere with their fertility.",{"id":157,"kind":154,"statement":158,"species":10,"limitation":10,"source_label":42},20021,"Read the carton for full instruction\nDIRECTIONS FOR USE\nRestraints:\nDO NOT USE on male animals.\nContraindications:\nContraindicated for use in mares suffering from uterine infections.\nPrecautions:\nUse with caution as unused feed must be destroyed and not given to any other animals.\nMATE must be added to the feed immediately prior to consumption and not stored.",{"id":160,"kind":154,"statement":161,"species":10,"limitation":10,"source_label":38},20022,"CONTRAINDICATIONS:\nDo not use Regu-Mate® (altrenogest) in mares having a previous or current history of uterine inflammation (e.g., acute, subacute, or chronic endometritis). Natural or synthetic gestagen therapy may exacerbate existing low-grade or \"smoldering\" uterine inflammation into a fulminating uterine infection in some instances.",{"id":163,"kind":154,"statement":164,"species":10,"limitation":10,"source_label":50},20023,"Do not use SwineMate® in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis).\nUnderdosing of SwineMate® may lead to the occurance of cysitc follicles.",{"id":166,"kind":167,"statement":168,"species":10,"limitation":10,"source_label":34},20024,"warning","WARNINGS AND PRECAUTIONS:\nUser Safety Warnings:\nNot for use in humans. Keep out of reach of children. Avoid skin contact. OvaMed is absorbed through unbroken skin, and exposure may result in serious side effects to both women and men. Wear vinyl, neoprene, or nitrile gloves when handling or administering OvaMed, or when touching contaminated surfaces or equipment. Latex gloves are not protective.\nPREGNANT WOMEN OR WOMEN WHO MAY BE PREGNANT SHOULD NOT HANDLE OVAMED. WOMEN OF CHILDBEARING AGE SHOULD EXERCISE EXTREME CAUTION WHEN HANDLING THIS PRODUCT.\nAccidental absorption, such as via direct contact with the skin, could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Immediately wash off accidental spillage on the skin with soap and water. Any equipment or surfaces that come in contact with OvaMed should be adequately cleaned and decontaminated to prevent human exposure (see Reported HUMAN Effects from Exposure).\nPotential Effects of Human Exposure:\nThere has been no human use of this specific product. The information contained in this section is extrapolated from data available on other products of the same pharmacological class that have been used in humans. Effects anticipated are due to the progestational activity of altrenogest.\nAcute effects after a single exposure are possible; however, continued daily exposure has the potential for more untoward effects such as disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy, and headaches. The oil base may also cause complications if swallowed.\nThe list of people who should not handle this product (see below is based upon the known effects of progestins used in humans on a chronic basis.\nPEOPLE WHO SHOULD NOT HANDLE OVAMED:\nWomen who are or may be pregnant.\nAnyone with blood clots or clotting disorders, or with a history of these events.\nAnyone with a history of heart disease or stroke.\nWomen with known or suspected breast cancer.\nPeople with known or suspected estrogen-dependent cancer.\nWomen with vaginal bleeding of unknown cause.\nPeople with tumors which developed during the use of oral contraceptives or other estrogen-containing products.\nAnyone with liver dysfunction or disease.\nACCIDENTAL EXPOSURE:\nOvaMed is readily absorbed through the skin. In addition, this oil based product can penetrate latex or other types of porous gloves. Always wear vinyl, neoprene, or nitrile gloves when handling or administering OvaMed. Latex gloves are not protective. If OvaMed gets inside gloves by damage or spilling, the covered skin may absorb more of the drug.\nIN CASE OF ACCIDENTAL EXPOSURE:\nSkin Exposure and\u002For clothing contamination: Wash skin immediately with soap and water, and launder clothing with detergent.\nEye Exposure: Immediately flush with plenty of water for 15 minutes. Get medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses.\nIf Swallowed: Do not induce vomiting. Seek medical attention immediately. OvaMed contains an oil. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the labeling to the physician.\nReported HUMAN Effects from Exposure:\nThese symptoms have been reported in women and men following accidental exposure to altrenogest products, including OvaMed, either through handling of the product or contact with contaminated surfaces:\nAdverse reproductive effects reported in women included abnormal or absent menstrual cycles.\nAdverse reproductive effects reported in men included decreased libido.\nOther adverse events reported in women and men included headaches, fever, abdominal pain, nausea, diarrhea, vomiting, and rashes.\nANIMAL SAFETY WARNINGS AND PRECAUTIONS:\nKeep OvaMed in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.\nVarious synthetic progestins, including altrenogest, when administered to rats during the embryogenic stage of pregnancy at doses manyfold greater than the recommended equine dose, caused fetal anomalies, especially masculinization of the female genitalia.\nOTHER WARNINGS:\nDo not use in horses intended for human consumption.\nCONTACT INFORMATION:\nTo report suspected adverse events, or to obtain product information, including Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332.\nFor additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http:\u002F\u002Fwww\u002Ffda.gov\u002Freportanimalae\nREPRODUCTIVE SAFETY STUDY:\nA 3-year well-controlled reproductive safety study was conducted in 27 pregnant mares, and compared with 24 untreated control mares. Treated mares received 2 mL altrenogest solution 0.22%\u002F110 lb body weight (2x dosage recommended for estrus suppression) from day 20 to day 325 of gestation. This study provided the following data:\nIn filly offspring (all ages) of treated mares, clitoral size was increased.\nFilly offspring from treated mares had shorter interval from Feb. 1 to first ovulation than fillies from their untreated mare counterparts.\nThere were no significant differences in reproductive performance between treated and untreated animals (mares & their respective offspring) measuring the following parameters:\ninterval from Feb. 1 to first ovulation, in mares only.\nmean interovulatory interval from first to second cycle and second to third cycle, mares only.\nfollicle size, mares only.\nat 50 days gestation, pregnancy rate in treated mares was 81.8% (9\u002F11) and untreated mares was 100% (4\u002F4).\nafter 3 cycles, 11\u002F12 treated mares were pregnant (91.7%) and 4\u002F4 untreated mares were pregnant (100%).\ncolt offspring of treated and control mares reached puberty at approximately the same age (82 & 84 weeks, respectively).\nstallion offspring from treated and control mares showed no differences in seminal volume, spermatozoal concentration, spermatozoal motility, and total sperm per ejaculate.\nstallion offspring from treated and control mares showed no difference in sexual behavior.\ntesticular characteristics (scrotal width, testis weight, parenchymal weight, epididymal weight and height, testicular height, width & length) were the same between stallion offspring of treated and control mares.\nReferences:\nShoemaker, C.F., E.L. Squires, and R.K. Shideler. 1989. Safety of Altrenogest in Pregnant Mares and on Health and Development of Offspring. Eq. Vet. Sci. (9); No. 2: 69-72.\nSquires, E.L., R.K. Shideler, and A.O. McKinnon. 1989: Reproductive Performance of Offspring from mares Administered Altrenogest During Gestation. Eq. Vet. Sci. (9); No. 2: 73-76.",{"id":170,"kind":167,"statement":171,"species":10,"limitation":10,"source_label":54},20025,"Horses: This drug is not to be administered to horses that are intended to be slaughtered for use in food.\nSwine: Treated animals must not be slaughtered for use in food for at least 42 days after the latest treatment with this drug.\nThe following individuals should not handle this product (based upon the known effects of progestins used in humans on a chronic basis):\n- Pregnant women or women who suspect they are pregnant.\n- Women with known or suspected breast, uterine, or endometrial hormone-dependent cancer.\n- Women with undiagnosed vaginal bleeding.\n- Persons with thrombophlebitis or thromboembolic disorders or with a history of these events.\n- Persons with cerebral-vascular or coronary-artery disease.\n- Persons with known or suspected estrogen-dependent neoplasia.\n- Persons with benign or malignant tumors which developed during the use of oral contraceptives or other estrogen-containing products.\n- Persons with liver dysfunction or disease.\nAltrenogest is readily absorbed by the skin. Avoid contact with skin or eyes and oral exposure. When handling this product, vinyl, neoprene or nitrile protective gloves must be worn.\nWomen of childbearing age should exercise extreme caution when handling this product. Accidental absorption could lead to a disruption of the menstrual cycle.\nThe following measures are recommended in case of accidental exposure:\n- Skin Exposure: Wash immediately with soap and water.\n- Eye Exposure: Immediately flush with plenty of water. Get medical attention.\n- If Swallowed: Do not induce vomiting. The product contains an oil. Call a physician. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. Show the product label to the physician.\nEffects of overexposure: There has been no human use of this product. The information in this section is extrapolated from data available on other products of the same pharmacological class that have been used in humans. Effects anticipated are due to the progestational activity of altrenogest. Acute effects after a single exposure are possible; however, continued daily exposure has the potential for more untoward effects such as disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy and headaches. The oil base may also cause complications if swallowed.\nKeep out of reach of children.",{"id":173,"kind":167,"statement":174,"species":10,"limitation":10,"source_label":46},20026,"There has been no human use of this specific product. The information contained in this section is extrapolated from data available on other products of the same pharmacological class that have been used in humans. Effects anticipated are due to the progestational activity of altrenogest.\nAcute effects after a single exposure are possible; however, continued daily exposure has the potential for more untoward effects such as disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation of pregnancy, and headaches. The oil base may also cause complications if swallowed.\nIn addition, the list of people who should not handle this product (see below) is based upon the known effects of progestins used in humans on a chronic basis.\nPEOPLE WHO SHOULD NOT HANDLE ALTREN®:\n1. Women who are or may be pregnant.\n2. Anyone with blood clots or clotting disorders, or with a history of these events.\n3. Anyone with a history of heart disease or stroke.\n4. Women with known or suspected breast cancer.\n5. People with known or suspected estrogen-dependent cancer.\n6. Women with vaginal bleeding of unknown cause.\n7. People with tumors which developed during the use of oral contraceptives or other estrogen-containing products.\n8. Anyone with liver dysfunction or disease.\nACCIDENTAL EXPOSURE:\nAltren® is readily absorbed through the skin. In addition, this oil-based product can penetrate latex or other types of porous gloves. Always wear vinyl, neoprene, or nitrile gloves when handling Altren®. Latex gloves are not protective. If Altren® gets inside gloves by damage or spilling, the covered skin may absorb more of the drug.\nIN CASE OF ACCIDENTAL EXPOSURE:\nSkin exposure and\u002For clothing contamination:\nWash skin immediately with soap and water, and launder clothing with detergent.\nEye exposure:\nImmediately flush with plenty of water for 15 minutes. Get medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses.\nIf swallowed:\nDo not induce vomiting. Seek medical attention immediately. Altren® contains an oil. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the labeling to the physician.",{"id":176,"kind":167,"statement":177,"species":10,"limitation":10,"source_label":50},20027,"Not for use in humans. Keep out of the reach of children.\nSkin contact must be avoided as SwineMate® is readily absorbed through unbroken skin, and exposure may result in serious side effects to both women and men. Always wear vinyl, neoprene or nitrile protective gloves when handling SwineMate or when in contact with equipment or surfaces contaminated by this product. Latex gloves are not protective.\nPREGNANT WOMEN OR WOMEN WHO MAY BE PREGNANT SHOULD NOT HANDLE SwineMate® (altrenogest). WOMEN OF CHILDBEARING AGE SHOULD EXERCISE EXTREME CAUTION WHEN HANDLING THIS PRODUCT.\nAccidental absorption, such as absorption through the skin, could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Wash off accidental spillage on the skin immediately with soap and water. Any equipment or surfaces that come in contact with SwineMate® should be adequately cleaned and decontaminated to prevent human exposure.\nPEOPLE WHO SHOULD NOT HANDLE SwineMate®:*\n1. Women who are or may be pregnant.\n2. Anyone with blood clots or clotting disorders, or with a history of these events.\n3. Anyone with a history of heart disease or stroke.\n4. Women with known or suspected breast cancer.\n5. People with known or suspected estrogen-dependent cancer.\n6. Women with vaginal bleeding of unknown cause.\n7. People with tumors which developed during the use of oral contraceptives or other estrogen-containing products.\n8. Anyone with liver dysfunction or disease.\n*Based on known effects of long-term progestin use in humans.",{"id":179,"kind":167,"statement":180,"species":10,"limitation":10,"source_label":50},20028,"Skin exposure and\u002For clothing contamination: Wash skin immediately with soap and water, and launder clothing with detergent.\nEye exposure: Immediately flush with plenty of water for 15 minutes. Get medical attention. If wearing contact lenses, flush eyes immediately with water before removing lenses.\nIf swallowed: Do not induce vomiting. Seek medical attention immediately. SwineMate® contains an oil. Vomiting should be supervised by a physician because of possible pulmonary damage via aspiration of the oil base. If possible, bring the labeling to the physician.\nReported HUMAN Effects from Exposure:\nSide effects have been reported in women and men following accidental exposure to altrenogest products, including SwineMate®, either through handling of the product or contact with contaminated surfaces.\nReproductive side effects reported in women included abnormal or absent menstual cycles.\nReproductive side effects in men included decreased libido.\nOther side effects reported in women and men included headaches, fever, abdominal pain, nausea, diarrhea, vomiting, and rashes.",{"id":182,"kind":167,"statement":183,"species":10,"limitation":10,"source_label":46},20029,"User Safety Warnings:\nNot for use in humans. Keep out of reach of children. Avoid skin contact. Altren® is absorbed through unbroken skin, and exposure may result in serious side effects to both women and men. Wear vinyl, neoprene, or nitrile gloves when handling or administering Altren®, or when touching contaminated surfaces or equipment. Latex gloves are not protective.\nPREGNANT WOMEN OR WOMEN WHO MAY BE PREGNANT SHOULD NOT HANDLE ALTREN®. WOMEN OF CHILDBEARING AGE SHOULD EXERCISE\nEXTREME CAUTION WHEN HANDLING THIS PRODUCT.\nAccidental absorption, such as via direct contact with the skin, could lead to a disruption of the menstrual cycle or prolongation of pregnancy. Immediately wash off accidental spillage on the skin with soap and water. Any equipment or surfaces that come in contact with Altren® should be adequately cleaned and decontaminated to prevent human exposure (see Reported HUMAN Effects from Exposure).",{"id":185,"kind":167,"statement":186,"species":10,"limitation":10,"source_label":141},20030,"While wearing vinyl, neoprene, or nitrile gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. This product can penetrate latex or other types of porous gloves. Latex gloves are not protective. Connect the MATRIX® Dosing Device to the solution bottle, according to the instructions provided with the MATRIX® Dosing Device package. Do not use any dosing device other than the MATRIX® Dosing Device.\nAdminister 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days. Treat gilts on an individual animal basis by top-dressing MATRIX® on a portion of each gilt's daily feed allowance. To produce the desired synchronization of estrus in a group of gilts, treat all of the gilts daily for the same 14-day period.",{"id":188,"kind":167,"statement":189,"species":10,"limitation":10,"source_label":42},20031,"Product is harmful if absorbed by skin contact, inhaled or swallowed. Avoid contact with eyes and skin. Do not inhale. When using the product wear rubber gloves. After use and before eating, drinking or smoking, wash hands, arms and face thoroughly with soap and water. After each day's use, wash gloves. Care should be taken to avoid contact between the solution and women of child bearing age.\nFIRST AID INSTRUCTIONS\nIf poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 13 11 26.\nADDITIONAL USER SAFETY INFORMATION\nAdditional information is listed in the safety data sheet (SDS).",{"id":191,"kind":167,"statement":192,"species":10,"limitation":10,"source_label":38},20032,"STORAGE, HANDLING, AND DISPOSAL:\nStore Regu-Mate® solution bottle and Dosing Device when loaded with solution for continued use at or below room temperature, 77°F (25°C). Close tightly. Refer to the Regu-Mate ® Equine Dosing Device label for equipment cleaning instructions. Place empty drug containers, waste from rinsing the Dosing Device, protective gloves, or other articles that contact this product in a leak-resistant container for disposal in accordance with applicable Federal, state, and local regulations.",{"id":194,"kind":167,"statement":195,"species":10,"limitation":10,"source_label":50},20033,"SwineMate® is readily absorbed from contact with the skin. In addition, this oil-based product can penetrate latex or other types of porous gloves. Always wear vinyl, neoprene, or nitrile protective gloves when handling SwineMate®. Latex gloves are not protective. If SwineMate® gets inside gloves by damage or spilling, the covered skin may absorb more of the drug. Side effects after a single exposure are possible; however, continued daily exposure has the potential for more serious effects.",{"id":197,"kind":167,"statement":198,"species":10,"limitation":10,"source_label":46},20034,"Keep Altren® in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.\nVarious synthetic progestins, including altrenogest, when administered to rats during the embryogenic stage of pregnancy at doses manyfold greater than the recommended equine dose, caused fetal anomalies, specifically masculinization of the female genitalia.",{"id":200,"kind":167,"statement":201,"species":10,"limitation":10,"source_label":46},20035,"When handling Altren® product or syringes, always use vinyl, neoprene, or nitrile gloves. Latex gloves are not protective. The product may be dosed using a luer lock syringe.",{"id":203,"kind":167,"statement":204,"species":10,"limitation":10,"source_label":50},20036,"WITHDRAWAL PERIODS\nAnimals intended for human consumption must not be slaughtered within 21 days of the last treatment with this drug product.",{"id":206,"kind":167,"statement":207,"species":10,"limitation":10,"source_label":46},20037,"Federal law restricts this drug to use by or on the order of a licensed veterinarian.",{"id":209,"kind":167,"statement":210,"species":10,"limitation":10,"source_label":38},20038,"WARNINGS AND PRECAUTIONS:",[212],{"id":213,"documentId":214,"slug":215,"name":216},999,"h9zuds6uolqui9wam0njw4fd","other-progestogens","Other progestogens",[],[],[]]