( doramectin and levamisole injection )
( 5 mg / mL doramectin , 150 mg / mL levamisole hydrochloride )
CAUTION : Federal law restricts this drug to use by or on the order of a licensed veterinarian .
INDICATIONS : VALCOR™ is indicated for the treatment and control of the following species of parasites in beef cattle two months of age and older and in replacement dairy heifers less than 20 months of age . Not for use in beef bulls intended for breeding over 1 year of age , dairy calves , and veal calves . Gastrointestinal Roundworms ( adults and fourth stage larvae ): Ostertagia ostertagi ( including inhibited larvae ), O . lyrata , Haemonchus placei , Trichostrongylus axei , T . colubriformis , T . longispicularis *, Cooperia oncophora , C . pectinata *, C . punctata , C . surnabada , Bunostomum phlebotomum *, Strongyloides papillosus *, Oesophagostomum radiatum , Trichuris spp .*, Nematodirus helvetianus *. Lungworms ( adults and fourth stage larvae ): Dictyocaulus viviparus . Eyeworms ( adults ): Thelazia spp . Grubs ( parasitic stages ): Hypoderma bovis , H . lineatum . Sucking Lice : Haematopinus eurysternus , Linognathus vituli , Solenopotes capillatus . Mange Mites : Psoroptes bovis , Sarcoptes scabiei . * Adults only
WARNINGS AND PRECAUTIONS :
WITHDRAWAL PERIODS AND RESIDUE WARNINGS : Cattle must not be slaughtered for human consumption within 15 days following last treatment with this drug product . Not for use in female dairy cattle 20 months of age or older , including dry dairy cows ; use in these cattle may cause drug residues in milk and / or in calves born to these cows or heifers . Not for use in beef calves less than 2 months of age , dairy calves , and veal calves . A withdrawal period has not been established for this product in pre-ruminating calves .
User Safety Warnings : Not for human use . Keep out of reach of children . If accidental eye contact occurs , flush eyes immediately with water for 15 minutes and seek medical attention . If wearing contact lenses , flush eyes immediately with water before removing lenses then continue rinsing for at least 15 minutes . Do not eat , drink or smoke while handling the product . Wash hands after use . Take care to avoid accidental self-injection . If accidental injection occurs , seek medical attention and provide product package insert to medical professional . To obtain a Safety Data Sheet ( s ), contact Zoetis Inc . at 1-888-963-8471 or www . zoetis . com .
Animal Safety Warnings and Precautions : Use of levamisole in cattle treated in the last few days with cholinesterase inhibitors such as organophosphates or with morantel may enhance the toxic effects of levamisole . Use together with caution . Destruction of Hypoderma larvae ( cattle grubs ) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities . Killing H . lineatum when it is in the tissue surrounding the gullet may cause bloat ; killing H . bovis when it is in the vertebral canal may cause staggering or paralysis . These reactions are not specific to treatment with VALCOR™ and can occur with any successful treatment of grubs . Cattle should be treated either before or after these stages of grub development . Consult your veterinarian concerning the proper time for treatment . Follow recommended dosage carefully . Reproductive safety has not been evaluated in bulls intended for breeding .
ADVERSE REACTIONS : This product is likely to cause swelling at the injection site . Tissue damage at the injection site may also occur , including possible granulomas and necrosis . These reactions have resolved without treatment . Local tissue reaction may result in trim loss of edible tissue at slaughter . A single death attributed to clostridial infection associated with the injection of VALCOR™ was reported in a nonpivotal effectiveness study . Observe cattle for injection site reactions . If injection site reactions are suspected , consult your veterinarian . This product is not for intravenous or intramuscular use . Hypersalivation may be observed ; however , this reaction will disappear within a few hours . If this condition persists , a veterinarian should be consulted .
Contact Information : Contact Zoetis Inc . at 1-888-963-8471 or www . zoetis . com . To report suspected
adverse drug experiences , contact Zoetis Inc . at 1-888-963-8471 . For additional information about reporting adverse drug experiences for animal drugs , contact FDA at 1-888-FDA-VETS or http :// www . fda . gov / reportanimalae .
TARGET ANIMAL SAFETY : Margin of Safety : Subcutaneous administration of VALCOR™ was well tolerated in calves as young as 3 months of age at 1 , 2 , or 3 times the recommended dose . Dose-dependent post-dose hypersalivation was seen in all treated groups compared to the controls . All cases of hypersalivation were mild , transient , and resolved without further medical intervention . Dose-related injection site reactions were observed , and those in the 1X group resolved between 21 and 28 days post injection . Injection site reactions were primarily swelling which resolved between 21 and 28 days post injection . Findings from the injection sites included swelling , edema , inflammation , muscle necrosis and fibrosis . Female Reproductive Safety : The reproductive safety of VALCOR™ was established in two studies with female cattle . First , a single dose of VALCOR™ was administered subcutaneously at 3 times the recommended dose at times coinciding with folliculogenesis , implantation , or organogenesis , and had no effects on conception , calving , abortion , and stillbirth rates , and post-natal viability up to 30 ± 2 days post-calving . There were no congenital abnormalities . The only test article-related change was an increase in incidence and duration of swelling at injection sites compared with control , but all swellings eventually resolved . In a second study , a single dose of VALCOR™ administered subcutaneously at 3 times the recommended dose at either early or late gestation had no effects on calving , abortion , and stillbirth rates , and post-natal viability up to 30 ± 2 days post-calving . One control calf and two treated calves were born with congenital abnormalities and did not survive . These were not determined to be test article-related . The only test article-related change was an increase in incidence and duration of swelling at injection sites , but all swellings eventually resolved . Not for use in bulls intended for breeding over 1 year of age , as reproductive safety has not been evaluated .
HOW SUPPLIED : VALCOR™ is available in 100 mL , 250 mL and 500 mL multi-dose , rubber-capped glass vials .
STORAGE , HANDLING , AND DISPOSAL : Store below 25 ° C ( 77 ° F ). Do not expose to light for extended periods of time . Do not contaminate water by direct application or by improper disposal of drug containers . Dispose of containers in an approved landfill or by incineration .
Approved by FDA under NADA # 141-553
Distributed by : Zoetis Inc . Kalamazoo , MI 49007
June 2022
www . NCBA . org
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40031685A & P
BLM ’ S CONSERVATION RULE
Continued from page 1 communities . NCBA President Mark Eisele called out the BLM for not listening to cattle producers in the media saying :
“ The BLM has a statutory responsibility to ensure multiple use on our nation ’ s public lands , which includes livestock grazing . It is extremely concerning that this rule makes serious additions to the leasing structure for federal lands without authorization or direction from Congress . Changes that aren ’ t based in law not only compromise the security of grazing on the landscape but make cohesive management much more challenging . Ranchers have always and will always be serious partners in conservation and sensible land management but after a year of feedback from agricultural organizations and local stakeholders , BLM has decided to move forward with the most concerning parts of this proposal .”
There never was a meaningful public engagement process on the contents of the rule . It was drafted without any input from producers , and the BLM scheduled public meetings for the rule but only in downtown metro areas , including Denver , Reno and Albuquerque . The BLM was trying to limit the number of actual producers who could attend these meetings and give feedback on the rule by holding the meetings at 5 p . m . on weekdays in cities hundreds of miles away from the areas this rule would impact . Ultimately , the BLM failed to listen to the stakeholders with the most to lose under this rule , and they undermined the working relationship the agency needs to have with ranchers . In the last 20 years , the agency has repeatedly justified cuts to grazing activities by arguing other uses provide more benefit , even in areas where this is scientifically and demonstrably false . Livestock production significantly boosts the economy in rural communities , and those economic benefits are now in jeopardy since the rule puts significant focus on the use of restrictive ACEC designations which have reduced grazing and public input on land management across the West . By going against the multiple-use mandate and increasing the use of ACECs , the BLM is increasing the likelihood of conflicts between who can legally access certain areas of federal land .
This rule has garnered strong support from numerous environmental and radical animal activist groups because it will eventually reduce the amount of cattle on public lands . These groups have made it clear they want to end livestock production entirely , but they have had little success in convincing the general public to be vegetarians or to eat less meat . Now , they invest more of their time pushing for incremental changes in the federal rulemaking process to try to slowly reduce the amount of cattle on public lands . This conservation rule and every new Endangered Species Act listing or habitat rulemaking is a test for these groups to see how effective they are in reducing livestock production . Then they will take their most effective tactics that worked on cattle grazing on public lands and unleash them on cattle producers on private lands .
The BLM is upending their multiple-use mandate and jeopardizing their ability to be a good partner to the ranchers who manage millions of acres across the West . While the administration is touting this rule as their success in conservation , it will ultimately harm the landscape . If not successfully reversed , this rule could cause widespread devastation not only to the cattle industry but to the other multiple uses that are crucial to rural economies . NCBA will not let ranchers become political footballs for this administration and will continue to protect the rights of ranchers who raise cattle on federal lands by working to block this rule either through Congressional or legal action .
NATIONAL CATTLEMEN 11