In the absence of any data relating to the adverse effects of tiludronic acid on the skeleton of young animals, do not administer to a horse less than 3 years old.

Do not administer to a horse with known impaired renal function.

The clinical effect of the product depends on the presence of osteolytic processes causing pain and leading to lameness. The product should be used only after a proper diagnosis combining a complete orthopaedic clinical examination including local analgesia and appropriate imaging techniques in order to identify the cause of pain and the nature of bone lesions.

It is advisable for an experienced horse person to observe the horse for the first four hours following the infusion due to the possible onset of side effects.

The product should be administered with caution in a hypocalcaemic horse. In this case, it is advised to slow down the rate of the infusion, as the risk of side effects might be increased under these circumstances. Also, these animals should be the subject of particularly close surveillance.

Because of its mild hypocalcaemic effect, the product should be administered with caution in animals with heart disorders. In this case, it is advisable to slow down the rate of infusion.

Avoid contact with skin and eyes.

Avoid accidental self-injection. It is recommended to insert the intravenous infusion needle into the vein before the reservoir containing the product is connected.

In the case of self injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Wear suitable gloves when preparing the solution for injection. Wash hands after use.

The safety of the product has not been studied in pregnant or lactating mares. The use of the product during pregnancy or lactation in mares is not recommended.

Do not mix or concomitantly administer intravenously the reconstituted solution with solutions containing divalent metal ions (Ca2+ or Mg2+) such as lactated Ringers. A solution of tiludronic acid may form complexes with these ions.

Avoid concomitant intravenous administration with drugs that can reduce serum calcium (such as tetracyclines) or whose toxicity can be exacerbated by a reduction in serum calcium (such as aminoglycosides).

Regarding other medicinal products, no data is available.

The main adverse reactions related to treatment with tiludronic acid are signs of discomfort or signs of colic (expressed as belly watching, yawning, pawing or kicking, stretching, light bruxism, often combined with restlessness), softening of faeces and sweating. These side effects were observed in less than 11% of horses treated with the recommended therapeutic regime.

The signs of colic appear within a few hours following treatment, are mild and transient and generally resolve spontaneously without requiring any specific treatment. If the signs persist, conventional treatments should be administered. Interactions with these treatments have not been assessed.

As recumbency can be experienced post infusion, be aware that the horse should be free to lie down in a comfortable unrestricted area.

An increase in frequency of signs of discomfort and restlessness is observed when the infusion duration is less than 15 minutes.

Meat and offal: Zero days

Not permitted for use in lactating animals producing milk for human consumption.

Keep out of reach and sight of children. For animal treatment only.