CALF_News_August_September_2020

40 CALF News • August | September 2020 • www.calfnews.net M any of us have probably had some revelations over the past several months as the coronavirus pandemic reshaped our world. Having wit- nessed empty grocery store shelves and limited availability of products, one of my revelations has certainly been a renewed appreciation for the abundance of product choices we typically enjoy – and have previously taken for granted. Similarly, for livestock production, ensuring the availability of product choices is key to the efficiency and sustainability of our industry in the future. In July 2019, Huvepharma had the opportunity to bring the first bioequivalent monensin product (Monovet ® 90 monensin Type A medicated article) to U.S. livestock produc- ers, after nearly 40 years of only one monensin choice in the marketplace. Monensin is an ionophore shown to improve feed efficiency, and prevent and control coccidiosis due to parasites among cattle fed in confinement. It can also be fed to growing cattle on pasture or in a dry lot for increased rate of weight gain and for prevention and control of coccidiosis, as well as to dairy cows for increased milk production efficiency, and to mature reproducing beef cows for improved feed efficiency when receiving supplemental feed and for the prevention and control of coccidiosis. Caution: Do not feed undiluted. Do not allow horses access to feeds, it can be fatal. Use in unapproved species may result in toxic reactions. Do not exceed the levels of monen- sin recommended in the feeding directions. For full product information, please visit http://www.huvepharma.us/products/ monovet-90. It’s been an exciting experience to introduce feedyard man- agers, dairy producers and mill managers to a new bioequiva- lent monensin choice. And not surprisingly, like any consumer considering a new product, I’ve fielded questions and curiosity about “bioequivalent.” What does it mean? To earn FDA approval and the opportunity to come into the marketplace, bioequivalent products must go through rigor- ous research trials proving that the bioequivalent has the same active ingredient, strength, dosage form and route of admin- istration as the brand-name, pioneer product. FDA sets the guidelines and tells the manufacturer what research trials they must conduct and meet to earn approval. There is a misconception that bioequivalent products only have to be 10 to 15 percent of the active ingredient compared to the pioneer product. That is not true. FDA is specific and detailed in their testing and performance requirements. Over the past 12 years, Huvepharma has per- formed extensive testing per FDA requirements to irrefutably demonstrate bioequivalence of Monovet 90 to the pioneer product. This included studies meeting Good Laboratory Practices (GLP), which determined Monovet 90 provides the same feed efficiency response as the pioneer; two separate GLP residue studies which showed that Monovet 90 and the pioneer behave the same with no resi- dues of concern from either product; and com- parative dissolution studies to further prove that Monovet 90 is bioequivalent to the pioneer. Market feedback But even with FDA approval, the next real test of our prod- uct has been earning “approval” from those using the product. As Monovet 90 has been introduced across the livestock indus- try, I’ve heard a common response of: “We will give it a try, but if it doesn’t work, we’ll go back to what we were using.” I wouldn’t expect anything less. The cattle business requires efficient, effective products – and managers watch closely to know if cattle are performing or not. Our monensin bioequivalent appears to cut the mustard. Over the past year, feedyard managers and cattle producers have fed the product to 10 million beef and dairy cattle – and counting. In visiting with these end-product users, the common senti- ment expressed to me is that they appreciate having a choice of medicated feed products in the marketplace. As one individual said to me,“Having options is never a bad thing.”  Bringing a Bioequivalent Choice to the Livestock Industry By Jay W. Johnson, Ph.D., Huvepharma 90 Cattle fed in confinement for slaughter: A. For improved feed efficiency. B. For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii . Dairy Cows: A. For increasedmilk production efficiency (production ofmarketable solids-correctedmilk per unit of feed intake). Growing cattleonpastureor indry lot (stockerand feederanddairyandbeef replacementheifers): A. For increased rate ofweight gain. B. For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii . MatureReproducingBeef Cows: A. For improved feed efficiencywhen receiving supplemental feed. B. For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii . Goats: A. For the prevention of coccidiosis caused by Eimeria crandallis , Eimeria christenseni ,and Eimeria ninakohlyakimovae in goatsmaintained in confinement. Calves (excluding veal calves): A. For the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii . CAUTION: Do not allow horses or other equines access to feeds containingmonensin. Ingestion ofmonensin by horses has been fatal. Monensinmedicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved speciesmay result in toxic reactions. Feeding undiluted ormixing errors resulting in high concentrations ofmonensin has been fatal to cattle and could be fatal to goats.Must be thoroughlymixed in feeds before use.Do not exceed the levels ofmonensin recommended in the feeding directions as reduced average daily gainsmay result.Do not feed to lactating goats. If feed refusals containingmonensin are fed to other groups of cattle, the concentration ofmonensin in the refusals and amount of refusals fed should be taken into consideration to preventmonensin overdosing. YOUMAYNOTICE: •Reduced voluntary feed intake in dairy cows fedmonensin. This reduction increaseswith higher doses ofmonensin fed. Rule outmonensin as the cause of reduced feed intake before attributing to other causes such as illness, feedmanagement, or the environment. •Reducedmilk fat percentage in dairy cows fedmonensin. This reduction increaseswith higher doses ofmonensin fed. •Increased incidence and treatment of cystic ovaries andmetritis in dairy cows fedmonensin. •Reduced conception rates, increased services per animal, and extended days open and corresponding calving intervals in dairy cows fedmonensin. Have a comprehensive and ongoing nutritional, reproductive and herd health program in placewhen feedingmonensin to dairy cows. NOT FORHUMANUSE WARNING: To report adverse effects, accessmedical information, or obtain additionalproduct information, call1-877-426-7765. Store at orbelow25ºC (77ºF). Excursionspermitted to37ºC (99ºF).Not tobeused afterdateprinted ongusset ofbag. RestrictedDrug (California) –UseOnly asDirected Approvedby FDAunderANADA#200-639 Huvepharma andMonovet are registered trademarks ofHuvepharma EOOD. DistributedbyHuvepharma Inc.,Peachtree City,GA30269,USA Directions foruse ReadAllDirections CarefullyBeforeMixing and Feeding ActiveDrug Ingredients:MonensinUSP,90.7gperpound. I. Cattle fed in confinement for slaughter: A. For improved feed efficiency. FeedingDirections: Thoroughlymix Monovet90 tomake one ton of complete feed that provides 5 to 40 g/tonmonensin on a 90% drymatter basis (Table 1). Feed complete feed (5 to 40 g/ton) continuously to growing finishing beef cattle to provide not less than 50 normore than 480mgmonensin per head per day.No additional improvement in feed efficiency has been shown from feedingmonensin at levels greater than 30 g/ton (360mgmonensin per head per day). B. For thepreventionand controlof coccidiosisdue to Eimeriabovis and Eimeria zuernii . FeedingDirections: Feed continuously (10 to40g/ton) toprovide0.14 to0.42mgperpoundofbodyweightperday,dependingupon severityof challenge,up toamaximumof480mgofmonensinperheadperday. II. DairyCows: A. For increasedmilkproductionefficiency (productionofmarketable solids-correctedmilkperunitof feed intake). FeedingDirections: TotalMixedRations ("complete feed"): Feed continuously todryand lactatingdairy cowsa totalmixed ration ("complete feed") containing11 to22g/tonmonensinona100%drymatterbasis (Table2). Component Feeding Systems (including topdress): Feed continuously to dry and lactating dairy cows a Type CMedicated Feed containing 11 to 400 g/tonmonensin (Table 3). The Type CMedicated Feedmust be fed in aminimum of 1 pound of feed per cow perday toprovide185 to660mg/head/daymonensin to lactating cowsor115 to410mg/head/daymonensin todry cows. This provides cowswith similaramountsofmonensin theywould receiveby consuming totalmixed rations containing11 to22g/ton monensinona100%drymatterbasis. Directions foruse continued on theback of thebag Directions foruse, continued V. Goats: A. Forprevention of coccidiosis causedby Eimeria crandallis , Eimeria christenseni , and Eimerianinakohlyakimovae . FeedingDirections: Feed complete feed (20 g/ton) continuously to goats as the sole ration (Table 1). Feed only to goatsmaintained in confinement. VI. Calves (excluding veal calves): A. For theprevention and control of coccidiosisdue to Eimeriabovis and Eimeria zuernii . Feed at a rate of 0.14 to 1.00mg per pound of bodyweight per day, depending upon severity of challenge, up to amaximum of 200mg ofmonensin per head per day. Themonensin concentration in Type CMedicated Feedmust be between 10 and 200 g/ton (Table 1). VII. TypeB or CMedicated FeedMixingDirections (Dry and Liquid): A. Dry or Liquid Thoroughlymix the following amounts of Monovet90 tomake one ton of TypeB or CMedicated Feed to provide the levels shown in Table 1.DryOnly – An Intermediateblending step shouldbeperformed to ensure an adequatemix. B. Liquid Limitations 1. The supplement pHmust be between 4.3 – 7.1. 2. Stored liquid TypeBMedicated Feeds containing Monovet : For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10minutes, moving not less than 1 percent of the tank contents perminute from the bottom of the tank to the top. Recirculate daily as described evenwhen not used. • For liquid feeds stored in mechanical, air or other agitation-type tank systems:Agitate immediately prior to use for not less than 10minutes creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described evenwhen not used. CAUTION: Inadequatemixing (recirculation or agitation) of monensin Liquid TypeB or CMedicated Feeds has resulted in increased monensin concentrationwhich has been fatal to cattle and could be fatal to goats. • If feed refusals containingmonensin are fed to other groups of cattle, the concentration ofmonensin in the refusals and amount of refusals fed should be taken into consideration to preventmonensin overdosing. Directions forUse:ReadAllDirections CarefullyBeforeMixing and Feeding Table1:MixingDirections for Cattle (excludingDairy Cows),Goat and Calf Feeds DesiredMonensin Concentration inMedicated Feed a AmountofMonovet90Neededper ton grams/ton mg/lb feed lbs. grams 5 2.5 0.06 25.00 20 10 0.22 100.02 30 15 0.33 150.03 40 20 0.44 200.04 400 200 4.41 2000.40 1200 600 13.23 6001.19 a 90% drymatter basis Table2:MixingDirections forDairy Cow TotalMixedRations (TMR) a Desiredmonensin concentration, Drymatter g/ton in TMR d AmountofMonovet 90neededper tonof TypeB, lb b Desiredmonensin concentration in TypeB Feed,g/ton;as-fedbasis c of TMR,% 11 15 22 lbof TypeB (as-fed)neededper tonof TMR AmountofMonovet90 Desiredmonensin Desiredmonensin concentration, neededper tonof concentration in TypeB g/ton in Component Feed TypeB, lb b Feed,g/ton;as-fedbasis c 004 002 05 lbof TypeB (as-fed)neededper tonof component feed NetWeight:25kg (55.12 lb) Awithdrawal time has not been established for pre-ruminating calves.Do not use in calves to be processed for veal.Whenmixing and handlingMonovet 90, use protective clothing, impervious gloves and a dustmask.Operators shouldwash thoroughlywith soap andwater after handling. If accidental eye contact occurs, immediately rinsewithwater. KCP-S00042 Rev. 07 -2019 (monensin Type A medicated article) For Animal Feed Only DoNot FeedUndiluted a Amount of TypeB (as-fed basis) needed to produce the component portion of the rationwith desired level ofmonensin is as follows: (Desired level ofmonensin in component, g/ton/ g/ton ofmonensin in TypeB) X 2000 Example TopDress:Desire 50 g/tonmonensin in component,& TypeB contains 500 g/ton ofmonensin. Example Solution: (50 g/ton/ 500 g/tonmonensin in TypeB) X 2000 = 200 lb of TypeB needed per ton of TopDress b (Desired concentration ofmonensin in TypeB feed, g/ton)/ 90.7 g/lb. Example: 500 g/ton/ 90.7 g/lb = 5.51 lbMonovet 90per ton of TypeB c It is recommended that TypeB feeds containingmore than 1440 g/ton be further diluted beforemixing into TopDress.An example of further dilutionwould be a ratio of 1:10 of TypeBMedicated Feed: Unmedicated Feed. 5.51 15.88 88.20 500 1400 8000 50 60 50 60 50 60 22.00 26.40 7.64 9.17 1.38 1.65 30.00 36.00 10.42 12.50 1.88 2.25 44.00 52.80 15.28 18.33 2.75 3.30 5.51 18.74 44.10 88.20 500 1700 4000 8000 200.00 58.82 25.00 12.50 800.00 235.29 100.00 50.00 1600.00 470.59 200.00 100.00 Monovet 90 Lot No. Exp. Date III. Growing cattle onpastureor indry lot (stocker and feeder anddairy andbeef replacementheifers): A. For increased rate ofweightgain. FeedingDirections: Feed at the rate of not less than 50 normore than 200mg per head per day in not less than one pound of Type CMedicated Feed; or after the 5th day, feed at the rate of 400mg per head per day every other day in not less than 2 pounds of Type CMedicated Feed. Themonensin concentration in the Type CMedicated Feedmust be between 15 and 400 grams per ton.During the first 5 days, cattle should receive nomore than 100mg per day contained in not less than 1 pound of feed. Do not self feed. B. For theprevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii . FeedingDirections: Feed at a rate to provide 0.14 to 0.42mg per pound bodyweight per day, depending upon severity of challenge, up to amaximum of 200mg per head per day. Themonensin concentration in Type CMedicated Feedmust be between 15 and 400 grams per ton. During the first 5 days, cattle should receive nomore than 100mg per day contained in not less than 1 pound of feed. C. Free-Choice (Self-Fed)Medicated Feeds. All Free-choicemedicated feedsmust provide not less than 50 normore than 200mgmonensin per head per day. (1) Free-choicemedicated feedsmanufactured from a published formula and/or specifications do not require aMedicated FeedMill License. (2)Othermanufacturers of Type C free choice feedswith a proprietary formula and/or specifications require an FDA approvedMedicated FeedMill License. IV. MatureReproducingBeef Cows (on pastureor indry lot): A. B. For improved feed efficiencywhen receiving supplemental feed. FeedingDirections: Feed continuously at a rate of 50 to 200mg per head per day.Blend into aminimum of 1 pound of Type CMedicated Feed and either hand feed ormix into the total ration. Feed (other than the Type CMedicated Feed containing Monovet ) can be restricted to 95% (of normal requirements)when 50mg ofmonensinactivity is fed,and to90%at200mg. Cowsonpastureor indry lotmust receiveaminimumof1poundof Type CMedicated Feed per head per day. Additionally, aminimum of 16 pounds (air-dry basis) of roughage such as silage, haylage, ammoniated straw, hay or equivalent feedstuffs should be fed in order tomeetNRC recommendations formature reproducing beef cows to gain 0.25 to 0.75 pounds per head per day. Standing, driedwinter range foragemay not be of adequate quality to result in improved efficiencywhen supplementedwith Monovet .During the first 5 days, pastured cattle should receive nomore than 100mg per day contained in not less than 1 pound of feed. Do not self feed. For theprevention and control of coccidiosisdue to Eimeriabovis and Eimeria zuernii . FeedingDirections: Feed at a rate of 0.14 to 0.42mg per pound of bodyweight per day, depending upon severity of challenge, up to amaximum of 200mg per head per day.During the first 5 days, pastured cattle should receive nomore than 100mg per day contained in not less than 1 pound of feed. a Amount of TypeB (as-fed basis) needed to produce the TMRwith desired level ofmonensin is as follows: ((Desired level ofmonensin in TMR g/ton) X (% drymatter of TMR)/g/ton ofmonensin in TypeB) X 2000 ExampleDiet:Desire 11 g/tonmonensin in TMR (drymatter basis), TMR contains 50% drymatter,& TypeB contains 500 g/ton ofmonensin. E xample Solution: ((11 g/ton) X (0.50 drymatter of TMR)/ 500 g/tonmonensin in TypeB) X 2000 = 22 lb of TypeB needed per ton of TMR b (Desired concentration ofmonensin in TypeB feed, g/ton)/90.7 g/lb. Example: 500 g/ton/ 90.7 g/lb = 5.51 lb Monovet 90 per ton of TypeB c It is recommended that TypeB feeds containingmore than 1440 g/ton be further diluted beforemixing into the TMR. An example of further dilutionwould be a ratio of 1:10 of TypeBMedicated Feed:Unmedicated Feed. d 100% drymatter basis Table3:MixingDirections forDairy Cows in Component Feeding Systems (Including TopDress) a