Equidronate 500 mg Lyophilisate for Solution for Infusion

None.
4.5 Special precautions for use
i. 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

Revised: March 2022
AN: 02782/2021Page 2 of 6
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 onset of 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 horse with disorders of heart function. In this case, it is advisable
to slow down the rate of infusion.
ii. 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.
4.6 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 restlessness), 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 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’

Revised: March 2022
AN: 02782/2021Page 3 of 6
4.7 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.
4.8 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.
4.9 Amounts to be administered and administration route
1 mg of tiludronic acid per kg of body weight, corresponding to 5 ml of reconstituted
solution per 100 kg, by intravenous route, by infusion.
The method of administration below should be followed:
-
of 0.9% Sodium Chloride solution or 5% Glucose solution from a 1 l to 3 l
infusion container.
-
powder.
-
-
infusion container
-
-
and connected to the infusion container with sterile disposable infusion tubing.
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.
4.10 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

Revised: March 2022
AN: 02782/2021Page 4 of 6
specific treatment. In cases where signs persist, conventional treatments should be
administered.
4.11 Withdrawal periods
Meat and offal: zero days
Not permitted for use in lactating animals producing milk for human consumption.
5.