Tildren
Active substance
ATC code
Species
Horses over 3 years of age.
Indications
As an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime.
Dose to be administered and administration route
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.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Preparation of the ready-to-use solution for infusion:
- Using a sterile needle and a suitable sterile disposable syringe, remove 25 ml of 0.9% Sodium Chloride solution or 5% Glucose solution from a 1 l to 3 l infusion container.
- Add the 25 ml of isotonic Sodium Chloride or Glucose solution to the vial of powder.
- Shake until the powder is completely dissolved. The concentrate appears as a clear, particle free and colourless solution.
- Adhering to strict aseptic technique, inject the reconstituted solution immediately into the infusion container
- Gently invert the container several times.
- Administer through a suitable needle or catheter inserted into the jugular vein and connected to the infusion container with sterile disposable infusion tubing.
- Each vial is for single use only. Cloudy solutions or solutions containing visible solid particles should not be administered.
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.
Adverse reactions
Horse:
|
Common (1 to 10 animals / 100 animals treated): |
Colic1 Discomfort2 (belly watching, yawning, pawing or kicking, stretching, light bruxism) Restlessness2 Increased sweating Soft stool |
|
Rare (1 to 10 animals / 10,000 animals treated): |
Acute renal failure3 |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Hypersensitivity reaction4 Anaphylaxis4 |
|
Undetermined frequency (cannot be estimated from the available data): |
Recumbency5 |
1 Signs of colic appear within a few hours following treatment, are mild and generally resolve without any specific treatment. In case signs persist, conventional treatments should be administered. The administration of an alpha 2 adrenergic agonist prior infusion may reduce the occurrence of signs of colic.
2 An increase in frequency of signs of discomfort and restlessness is observed when the infusion duration is less than 15 minutes.
3 may occur within 1 week after administration. Renal parameters should be monitored before administration and water consumption and urine output should be monitored where possible after administration. Renal insufficiency is more frequently observed in animals concurrently exposed to NSAIDs. In these cases, appropriate fluid therapy should be instituted, and renal parameters monitored.
4 signs of reaction ranged from urticaria to anaphylactic shock, which can be fatal. A ppropriate treatment should be sought immediately.
5 may occur after the infusion. Care should be taken to ensure that the horse can lie down in a comfortable, unrestricted area.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
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