b'O SPHOS(clodronate injection)BisphosphonateFor 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, chloro- containing 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.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 acci-dental human exposure.PRECAUTIONS: As a class, bisphosphonates may be associ-ated 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 im-pairment 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 mon-itored. Use of bisphosphonates in patients with conditions or diseasesaffectingrenalfunctionisnotrecommended. O SPHOSAdministrationofbisphosphonateshasbeenassociated 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 controls the2 hours of treatment. Horses should be monitored for at least 2 hours following administration of OSPHOS.Bisphosphonates affect plasma concentrations of some min-erals and electrolytes such as calcium, magnesium and po-clinical signstassium, 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, Easily Administered associatedhypocalcemia, etc.).The safe use of OSPHOS has not been evaluated in horses less than 4 years of age. The effect of bisphosphonates on the skel-eton of growing horses has not been studied; however, bisphos-via intramuscular injection phonates inhibit osteoclast activity which impacts bone turnover with Navicularand may affect bone growth.Well Tolerated* Bisphosphonates should not be used in pregnant or lactating mares, or mares intended for breeding. The safe use of OSPHOS in clinical trials Syndrome has not been evaluated in breeding horses or pregnant or lac-tating 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 Proven Efficacy* back into the systemic circulation, is directly related to the to-tal dose and duration of bisphosphonate use. Bisphosphonates at 6 months post treatment 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, No Reconstitutionincluding bisphosphonates, may be excreted in milk and may be absorbed by nursing animals.Required 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; how-Learn more onlineever, a causal relationship has not been established.ADVERSE REACTIONS: The most common adverse reactions www.dechra-us.com reported in the field study were clinical signs of discomfort or nervousness, colic and/or pawing. Other signs reported were www.osphos.com lip licking, yawning, head shaking, injection site swelling, and hives/pruritus.As with all drugs, side effects may occur. In field studies, the most common side effects reported were signs of discomfort or nervousness, colic, and/or pawing. OSPHOS should not be used in pregnant or lactating mares, or mares intended for breeding.Distributed by: Dechra Veterinary ProductsUse of OSPHOS in patients with conditions affecting renal function or mineral or electrolyte homeostasis is not recommended.7015 College Boulevard, Suite 525Refer to the prescribing information for complete details or visit www.dechra-us.com or call 866.933.2472. Overland Park, KS 66211 866-933-2472CAUTION: Federal law restricts this drug to use by or on the order of licensed veterinarian. 2016 Dechra Ltd. OSPHOS is a registeredtrademark of Dechra Ltd. All rights reserved.* Freedom of Information Summary, Original New Animal Drug Application, NADA 141-427, for OSPHOS. April 28, 2014.NADA 141-427, Approved by FDADechra Veterinary Products US and the Dechra D logo are registered trademarks of Dechra Pharmaceuticals PLC. 2016 Dechra Ltd.'