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Audevard Tildren 500mg Lyophilisate for solution for infusion

Audevard

Item no: TILDREN
 
Prescription Medicine
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Audevard Tildren 500mg for Horses

Target species:
Horses over 3 years of age.

Indications for use, specifying the target species:
As an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime.


Contraindications:
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'.

Special warnings:
None.

Special precautions for use:
Special precautions for use in animals
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.

Adverse reactions (frequency and seriousness):
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.

Use during pregnancy, lactation or lay:
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.

Interaction with other medicinal products and other forms of interaction:
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.

Amounts 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. 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 I to 3 I 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.

Overdose (symptoms, emergency procedures, antidotes), if necessary:
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.

Withdrawal Periods:
Meat and offal: zero days
Not permitted for use in lactating animals producing milk for human consumption

 

Shipping charges mainland GB zone1

Value Weight Delivery Charge
Over £49.00 Any Weight FREE
Under £49.00 No weight limit £4.50
Under £49.00 Under 250 grams £3.49

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Refrigerated Items

  • Refrigerated lines Packaging Cost: Despatched with Woolcool Refrigerated Packaging for £7.50.
Wool cool keeps pharmaceutical products at fridge-like, ambient, or even freezing temperatures for up to 72 hours, and possibly longer depending on the contents and use of ice packs.
Important Delivery Information:
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  • Immediate Refrigeration: Upon receipt, refrigerate the contents immediately to ensure your food or medicine remains at the correct temperature.
  • Failed Delivery Attempts: We are not responsible for the cost of replacements if a delivery attempt fails due to the absence of someone to receive it.

We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email sales@hyperdrug.co.uk to obtain a returns number.

*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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