b'O SPHOS(clodronate injection)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, chloro-containing bisphosphonate. Chemically, clodronate disodium is (dichloromethylene) diphosphonic acid disodi-um 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 accidental human exposure.PRECAUTIONS: As a class, bisphosphonates may be associated with gastrointestinal and renal toxicity. Sen-sitivity 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 patientswith conditions or diseases affecting renal function is not recommended. Administration of bisphosphonates has Ebeen associated with abdominal pain (colic), discomfort, and agitation in horses. Clinical signs usually occur shortly after drug administration and may be associated with Nalterations 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 Ihours following administration of OSPHOS.LBisphosphonates affect plasma concentrations of some Pminerals and electrolytes such as calcium, magnesium and potassium, immediately post-treatment, with effects I lasting up to several hours. Caution should be used when administering bisphosphonates to horses with conditions Caffecting mineral or electrolyte homeostasis (e.g. hyper-kalemic periodic paralysis, hypocalcemia, etc.).SThe safe use of OSPHOS has not been evaluated in hors-I es less than 4 years of age. The effect of bisphosphonates Don the skeleton of growing horses has not been studied; however, bisphosphonates inhibit osteoclast activity which Eimpacts bone turnover and may affect bone growth.Bisphosphonates should not be used in pregnant or Nlactating mares, or mares intended for breeding. The I safe use of OSPHOS has not been evaluated in breeding U horses or pregnant or lactating mares. Bisphosphonates F Q are incorporated into the bone matrix, from where they are OR EE gradually released over periods of months to years. The VERY 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 abnormal-ities 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.The intramuscularIncreased 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 bisphosphonate injection 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.for control of clinical signs associatedADVERSE REACTIONS: The most common adverse reactions reported in the eld study were clinical signs Learn more onlineof discomfort or nervousness, colic and/or pawing. Other with Navicular Syndrome www.dechra-us.com signs reported were lip licking, yawning, head shaking, injection site swelling, and hives/pruritus.www.osphos.comAs with all drugs, side effects may occur. The most common adverse reactions reported in the eld study were clinical signs of discomfort or nervousness, colic and/or pawing. Other signs reported were: lip licking, yawning, head shak-ing, injection site swelling, and hives/pruritus. Osphos should not be used in pregnant or lactating mares, or mares intended for breeding. 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.osphos.com. Distributed by: Dechra Veterinary Products7015 College Boulevard, Suite 525Overland Park, KS 66211 866-933-2472CAUTION: Federal law restricts this drug to use by or on the order of licensed veterinarian.2018 Dechra Ltd. OSPHOS is a registered* Freedom of Information Summary, Original New Animal Drug Application, NADA 141-427, for OSPHOS. April 28, 2014.trademark of Dechra Ltd. All rights reserved.Dechra Veterinary Products US and the Dechra D logo are registered trademarks of Dechra Pharmaceuticals PLC. 2018 Dechra Ltd. NADA 141-427, Approved by FDA'