Horses over 3 years of age.

As an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime.

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. Renal function should ideally be evaluated prior to treatment.

Do not use in case of know hypersensitivity to bisphosphonates or to any of the excipients. See sections 'Use during pregnancy, lactation or lay' and 'Withdrawal Periods'.

None.

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 recommended to respect the recommended 30 minute duration of infusion as the duration of infusion has an effect on the occurrence or severity of the adverse reactions.

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

The product should be administered with caution in a hypocalcemic 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, these animals should be the subject of particularly close surveillance.

Because of its mild hypocalcemic effect, the product should be administered with caution in horses with disorders of heart function. 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 impervious gloves when preparing the solution for injection.

Wash hands after use.

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 restleness), softening of faeces and sweating. These side effects were observed in less than 15% of horses treated with the recommended therapeutic scheme.

The signs of colic appear within a few hours following treatment, are mild and transient and generally resolve spontaneously without requiring any specific treatment. In case signs persist, a non steroidal anti-inflammatory treatment or a spasmolytic treatment should be administered. The administration of an alpha 2 adrenergic agonist prior to infusion may reduce the occurrence of signs of colic. 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.

On very rare occasions (less than 1 out of 20,000 horses) allergic or anaphylactic like reactions have been reported in treated horses: signs of reaction ranged from urticaria to anaphylactic shock which can be fatal.

In rare cases, acute renal failure may occur within 1 week after administration of the product. Renal parameters should be monitored before administration of the product and water consumption and urine output should be monitored where possible after administration.

Studies conducted on laboratory animals (mice, rats, rabbits) did not reveal any embryotoxic, foetotoxic or teratogenic effects nor effects on peri- or post-natal development. Particularly, no adverse effects have been observed on the skeleton. 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).

In a field trial, the co-administration of the product with NSAIDs, spasmolytics or alpha 2 adrenergic agonists was well tolerated.

Regarding other medicinal products, no data are available.

Intravenous infusion after reconstitution and dilution.

1 mg of tiludronic acid per kg of body weight, corresponding to 5 ml of reconstituted solution per 100 kg. Preparation of the ready-to-use solution for infusion:

The product should be infused over 30 minutes at an even rate. Fluctuations in the infusion rate could increase the risk of the horse showing signs of colic during or after the infusion.

Do not exceed the infusion rate as this could increase the risk of the horse showing signs of colic during or after infusion.

Do not exceed the recommended dosage.

At 2, 3 or 5 times the recommended dosage, an increase in frequency of the side effects, in particular restlessness, signs of discomfort or signs of colic, is observed. These signs may appear during or after the infusion, are usually mild and transient and generally resolve spontaneously at the end of the infusion without requiring any specific treatment. In cases where signs persist, conventional treatments should be administered.

Meat and offal: zero days

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