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Tildren for Horses 500 mg, 30 ml vial Rx

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Product Description

Tildren is indicated for the control of clinical signs associated with navicular syndrome in horses. It is a bisphosphonate drug for intravenous infusion. Each 30 ml vial contains a sterile powder of 500 mg tiludronic acid (as tiludronate disodium) and 250 mg mannitol USP.   

What is Tildren for Horses 500 mg, 30 ml vial?

Tildren is indicated for the control of clinical signs associated with navicular syndrome in horses.

Who is Tildren for Horses 500 mg, 30 ml vial for?

Horses (4 years of age or older)

Why use Tildren for Horses 500 mg, 30 ml vial?

-Indicated for horses with Navicular Syndrome

How does Tildren for Horses 500 mg, 30 ml vial work?

Tildren is a bisphosphonate drug for intravenous infusion. Each 30 ml vial contains a sterile powder of 500 mg tiludronic acid (as tiludronate disodium) and 250 mg mannitol USP. Tildren contains the sodium salt of tiludronic acid, which is a bisphosphonate characterized by a (4-chlorophenylthio) group on the carbon atom of the basic P-C-P structure common to all bisphosphonates. Its United States Adopted Name (USAN) is tiludronate disodium. Tiludronate disodium is the hydrated hemihydrate form of the disodium salt of tiludronic acid. Its chemical name is [[(4-Chlorophenyl) thio]methylene] bis[phosphonic acid], disodium salt.

Manufacturer:

Ceva Animal Health

Active ingredient(s):

Tiludronate Disodium

How is Tildren for Horses 500 mg, 30 ml vial sold?

500 mg, 30 ml vial

What are the side effects of Tildren for Horses 500 mg, 30 ml vial?

CONTRAINDICATIONS: Do not use in horses with known hypersensitivity to tiludronate disodium or to mannitol. Do not use in horses with impaired renal function or with a history of renal disease. Bisphosphonates are excreted by the kidney; therefore, conditions causing renal impairment may increase plasma bisphosphonate concentrations resulting in an increased risk for adverse reactions. WARNINGS : Do not use in horses intended for human consumption. NSAIDs should not be used concurrently with TILDREN. Concurrent use of NSAIDs with TILDREN may increase the risk of renal toxicity and acute renal failure. Acute renal failure has been reported in horses concurrently administered NSAIDs and TILDREN within a 48 hour period. Additionally, horses concurrently administered TILDREN and NSAIDs in field studies demonstrated a statistically significant increase in serum blood urea nitrogen (BUN) and creatinine concentrations. These elevations were not always associated with clinical signs of renal dysfunction. Therefore, appropriate wash-out periods should be observed between NSAID and TILDREN administration, and BUN and creatinine should be monitored. If treatment for discomfort is required after TILDREN administration, a non-NSAID treatment should be used.

What special precautions are there?

Not for human use. Keep this and all drugs out of the reach of children. Do not use in pregnant, lactating, or breeding animals. Approximately 30-45% of horses administered Tildren will demonstrate transient signs consistent with abdominal pain (colic). Clinical signs usually occur shortly after Tildren administration and may be associated with alterations in intestinal motility. Horses should be observed closely for 4 hours post-infusion for the development of clinical signs consistent with colic or other adverse reactions. Colic signs can last approximately 90 minutes and may be intermittent in nature. Hand-walking the horse may improve or resolve the colic signs in many cases. If a horse requires medical therapy, non-NSAID treatments should be administered due to the risk for renal toxicity. Avoid NSAID use.

What to do if overdose?

Contact your nearest emergency animal hospital

How can I store Tildren for Horses 500 mg, 30 ml vial?

Sterile powder (not reconstituted): Store at controlled room temperature 68-77° F (20-25° C). After preparation, the infusion should be administered either within 2 hours of preparation, or it can be stored for up to 24 hours under refrigeration at 36-46° F (2-8° C) and protected from light.

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DOSAGE AND ADMINISTRATION
A single dose of TILDREN should be administered as an intravenous infusion at a dose of 1 mg/kg (0.45 mg/lb). The infusion should be administered slowly and evenly over 90 minutes to minimize the risk of adverse reactions.
Maximum effect may not occur until 2 months post-treatment.
 
DIRECTIONS FOR ADMINISTRATION
Do not reconstitute or mix TILDREN with calcium containing solutions or other solutions containing divalent cations such as Lactated Ringers as it may form complexes with these ions.
 
STEP 1: Preparation of the reconstituted solution (20 mg/mL). TILDREN should be reconstituted using strict aseptic technique. Remove 25 mL of solution from a 1 liter bag of sterile 0.9% Sodium Chloride Injection, USP and add it to one vial of TILDREN. Shake gently until the powder is completely dissolved. This reconstituted solution contains 20 mg of tiludronate disodium per mL. After reconstitution further dilution is required before administration.
 
STEP 2: Preparation of the solution for infusion. Using strict aseptic technique, withdraw the appropriate volume of the reconstituted solution based on the horse’s body weight (see Table 1 below). Inject that volume back into the 1 liter bag of sterile 0.9% Sodium Chloride Injection, USP. Horses greater than 1,210 lbs. will require a second vial of reconstituted TILDREN solution. Invert the infusion bag to mix the solution before infusion. Label the infusion bag to ensure proper use.
After preparation, the infusion should be administered either within 2 hours of preparation, or it can be stored for up to 24 hours under refrigeration at 36-46° F (2-8° C) and protected from light.
 
STEP 3: Administer for infusion through a suitable intravenous catheter inserted into a jugular vein and connected to the infusion bag using sterile disposable infusion tubing.

Tiludronate Disodium

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