CEVA |
83842G

Tildren Injection

Prescription Product

This is a Schedule 4 (S4) Controlled Substance. Supply is strictly regulated under Australian law. Valid authorisation is required to purchase this product.

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Treatment for bone and cartilage-related lameness such as that of Navicular Disease and Bone Spavin

COMPOSITION
TILUDRONIC ACID 50 mg/vial (as disodium tiludronate 56.91 mg/vial) Powder and solvent for intravenous injection. Solvent is water for injection.

ACTIONS
Tiludronic acid belongs to the bisphosphonate therapeutic class, a class of products with activity on bone metabolism. The main pharmacological property of TILDREN lnjection is to reduce bone resorption by inhibiting the activity of osteoclasts.
TILDREN lnjection acts as a regulator of bone remodelling in all situations involving excessive bone resorption. This regulator effect is not associated with a negative effect on bone formation or bone mineralisation at the recommended therapeutic dosage.
Areas of reduced bone density are a pathological change common to most cases of Navicular Disease and Bone Spavin and are due to inappropriate resorption of bone ("osteolysis"). In double-blind, placebo-controlled clinical trials for both conditions, TILDREN treatment produced clear improvement as demonstrated by longterm reduction in lameness and progressive resumption of sporting activity.
In another double-blind, placebo-controlled clinical trial into the treatment of back pain associated with bony lesions of the vertebral column, TILDREN treatment induced a clear improvement in back flexibility, however further research is required to add this indication as a registered claim. Other studies have shown that TILDREN treatment can prevent the bone loss which usually occurs during inactivity in horses, as shown by measurements of bone density in spelling horses.
TILDREN lnjection has also demonstrated anti-arthritic properties in a model of poly-arthritis in rats. In vitro data identified inhibiting effects on the secretion of enzymes which degrade cartilage matrix.

INDICATIONS
Treatment of lameness associated with bone and cartilage changes in horses.

PRESENTATION
Carton contains:
10 vials of 50 mg freeze-dried powder (Tildren) and
10 vials of 10 mL solvent (Water for injection).
Each carton provides a 10-day treatment course for a 500 kg horse.

STORAGE
Store below 25°C (Air conditioning) in outer carton. Shelf life after reconstitution: As the product contains no preservatives it should be stored between 2°C and 8°C for no longer than 24 hours following reconstitution. Refrigerate. Do not freeze.

WARNINGS
Due to the lack of studies on the adverse effects of Tiludronic acid on the skeleton of young animals, this product is not recommended in horses younger than 2 years of age.
Safety in pregnant or lactating mares has not been established.
Meat Withholding Period: NOT TO BE USED in horses that will be slaughtered for human consumption. When administering to competition horses, ensure that the regulations of relevant authorities are observed.
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Classification:
S4
Categorisation:
Prescription