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THE COMPETITIV MARCH APRIL 2020 ISSUE 26 QUESTRIAN THE SPECIALISTS JOHN FRENCH FINDS HIS NICHE ALONGSIDE KENT FARRINGTON BETTER TOGETHER HOW REBECCA BRUCE AND NED GLYNN NAVIGATE LOVE AND HORSES LENS ENVY ELEGANT EQUUS LINDSAY BROWN TCE LIFE PASO ROBLES PALM BEACH MASTERS SERIES HIGHLIGHTS LONGINES FEI JUMPING WORLD CUP WELLINGTON NATIONS CUP OF USA WINTER EQUESTRIAN FESTIVAL HIGHLIGHTS 50 000 MARS EVENTING SHOWCASE FEI CSI5 401 000 FIDELITY INVESTMENTS GRAND PRIX
IS CIP LIN E OSPHOS clodronate injection F O R E V E RY N I U EQ D E The intramuscular bisphosphonate injection for control of clinical signs associated with Navicular Syndrome in horses 4 years of age and older Learn more online www dechra us com www osphos com As with all drugs side effects may occur In field studies and post approval experience the most common side effects reported were signs of discomfort nervousness and colic Other signs reported were renal insufficiency failure anorexia lethargy hypercalcemia behavioral disorders hyperkalemia hyperactivity recumbency hyperthermia injection site reactions muscle tremor urticaria hyperglycemia and fracture In some cases death has been reported as an outcome of these adverse events The safe use of OSPHOS has not been evaluated in horses less than 4 years of age or breeding horses OSPHOS should not be used in pregnant or lactating mares or mares intended for breeding NSAIDs should not be used concurrently with OSPHOS Concurrent use of NSAIDs with OSPHOS may increase the risk of renal toxicity and acute renal failure Use of OSPHOS in patients with conditions affecting renal function or mineral or electrolyte homeostasis is not recommended Refer to the prescribing information for complete details or visit www dechra us com CAUTION Federal law restricts this drug to use by or on the order of licensed veterinarian Freedom of Information Summary Original New Animal Drug Application approved by FDA under NADA 141 427 for OSPHOS April 28 2014 Dechra Veterinary Products US and the Dechra D logo are registered trademarks of Dechra Pharmaceuticals PLC 2019 Dechra Ltd Bisphosphonate For use in horses only Brief Summary For Full Prescribing Information see package insert CAUTION Federal USA law restricts this drug to use by or on the order of a licensed veterinarian DESCRIPTION Clodronate disodium is a non amino chlorocontaining bisphosphonate Chemically clodronate disodium is dichloromethylene diphosphonic acid disodium salt and is manufactured from the tetrahydrate form INDICATION For the control of clinical signs associated with navicular syndrome in horses CONTRAINDICATIONS Horses with hypersensitivity to clodronate disodium should not receive OSPHOS Do not use in horses with impaired renal function or with a history of renal disease WARNINGS Do not use in horses intended for human consumption HUMAN WARNINGS Not for human use Keep this and all drugs out of the reach of children Consult a physician in case of accidental human exposure PRECAUTIONS OSPHOS has been associated with renal toxicity Concurrent administration of other potentially nephrotoxic drugs should be approached with caution and renal function should be monitored Use of bisphosphonates in patients with conditions or diseases affecting renal function is not recommended Horses should be well hydrated prior to and after the administration of OSPHOS due to the potential for adverse renal events Water intake and urine output should be monitored for 3 5 days post treatment and any changes from baseline should elicit further evaluation As a class bisphosphonates may be associated with gastrointestinal and renal toxicity Sensitivity to drug associated adverse reactions varies with the individual patient Renal and gastrointestinal adverse reactions may be associated with plasma concentrations of the drug Bisphosphonates are excreted by the kidney therefore conditions causing renal impairment may increase plasma bisphosphonate concentrations resulting in an increased risk for adverse reactions Concurrent administration of other potentially nephrotoxic drugs should be approached with caution and renal function should be monitored Use of bisphosphonates in patients with conditions or diseases affecting renal function is not recommended Administration of bisphosphonates has been associated with abdominal pain colic discomfort and agitation in horses Clinical signs usually occur shortly after drug administration and may be associated with alterations in intestinal motility In horses treated with OSPHOS these clinical signs usually began within 2 hours of treatment Horses should be monitored for at least 2 hours following administration of OSPHOS Bisphosphonates affect plasma concentrations of some minerals and electrolytes such as calcium magnesium and potassium immediately post treatment with effects lasting up to several hours Caution should be used when administering bisphosphonates to horses with conditions affecting mineral or electrolyte homeostasis e g hyperkalemic periodic paralysis hypocalcemia etc The safe use of OSPHOS has not been evaluated in horses less than 4 years of age The effect of bisphosphonates on the skeleton of growing horses has not been studied however bisphosphonates inhibit osteoclast activity which impacts bone turnover and may affect bone growth Bisphosphonates should not be used in pregnant or lactating mares or mares intended for breeding The safe use of OSPHOS has not been evaluated in breeding horses or pregnant or lactating mares Bisphosphonates are incorporated into the bone matrix from where they are gradually released over periods of months to years The extent of bisphosphonate incorporation into adult bone and hence the amount available for release back into the systemic circulation is directly related to the total dose and duration of bisphosphonate use Bisphosphonates have been shown to cause fetal developmental abnormalities in laboratory animals The uptake of bisphosphonates into fetal bone may be greater than into maternal bone creating a possible risk for skeletal or other abnormalities in the fetus Many drugs including bisphosphonates may be excreted in milk and may be absorbed by nursing animals Increased bone fragility has been observed in animals treated with bisphosphonates at high doses or for long periods of time Bisphosphonates inhibit bone resorption and decrease bone turnover which may lead to an inability to repair micro damage within the bone In humans atypical femur fractures have been reported in patients on long term bisphosphonate therapy however a causal relationship has not been established ADVERSE REACTIONS The most common adverse reactions reported in the field study were clinical signs of discomfort or nervousness colic and or pawing Other signs reported were lip licking yawning head shaking injection site swelling and hives pruritus POST APPROVAL EXPERIENCE December 2018 The following adverse events are based on post approval adverse drug experience reporting Not all adverse events are reported to FDA CVM It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data The following adverse events are listed in decreasing order of reporting frequency renal failure polyuria polydipsia abdominal pain anorexia lethargy hypercalcemia behavioral disorder discomfort hyperkalemia hyperactivity recumbency hyperthermia injection site reactions muscle tremor urticaria hyperglycemia and fracture In some cases death has been reported as an outcome of the adverse events listed above INFORMATION FOR HORSE OWNERS Owners should be advised to NOT administer NSAIDs Ensure horses have access to adequate water before and after administration of OSPHOS Observe their horse for at least 2 hours post treatment for signs of colic agitation and or abnormal behavior If a horse appears uncomfortable nervous or experiences cramping post treatment hand walk the horse for 15 minutes If signs do not resolve contact the veterinarian Monitor water intake and urine output for 3 5 days posttreatment Contact their veterinarian if the horse displays abnormal clinical signs such as changes in drinking and urination appetite and attitude Manufactured for Dechra Veterinary Products 7015 College Blvd Suite 525 Overland Park KS 66211 866 933 2472 2019 Dechra Ltd OSPHOS is a registered trademark of Dechra Ltd All rights reserved Approved by FDA under NADA 141 427
THE COMPETITIV MARCH APRIL 2020 ISSUE 26 QUESTRIAN THE SPECIALISTS JOHN FRENCH FINDS HIS NICHE ALONGSIDE KENT FARRINGTON BETTER TOGETHER HOW REBECCA BRUCE AND NED GLYNN NAVIGATE LOVE AND HORSES LENS ENVY ELEGANT EQUUS LINDSAY BROWN TCE LIFE PASO ROBLES PALM BEACH MASTERS SERIES HIGHLIGHTS LONGINES FEI JUMPING WORLD CUP WELLINGTON NATIONS CUP OF USA WINTER EQUESTRIAN FESTIVAL HIGHLIGHTS 50 000 MARS EVENTING SHOWCASE FEI CSI5 401 000 FIDELITY INVESTMENTS GRAND PRIX
