Recudon 2.5 mg/ml + 0.125 mg/ml Solution for Injection for Horses and Dogs

Due to the variable individual response to levomethadone, animals should be
monitored regularly to ensure sufficient efficacy for the desired duration of effect.
For methadone it has been described that Greyhounds may require higher doses than
other breeds to achieve efficacious plasma levels. No corresponding information is
available on the requirement for higher doses of specifically levomethadone in
greyhounds, when compared to other breeds.

Special precautions for safe use in the target species
It is recommended that dogs are fasted for 12 hours prior to administration of the
veterinary medicinal product. In dogs, this veterinary medicinal product should be
injected very slowly when used intravenously. Restlessness and howling of the
animals during the injection are signs of underdosing, so the injection should be
continued.
Because the effects last for several hours, the animal should be protected from
acoustic stimuli, and should be kept warm and dry until fully recovered.
Adequate oxygenation should be ensured during treatment, treated animals should be
monitored regularly, including examination of heart rate and respiratory rate.
Use cautiously in animals with head injuries, as the effect of an opioid on head injury is
dependent on the type and severity of the injury and the respiratory support supplied.
As methadone is metabolised by the liver, its intensity and duration of action may be
affected in animals with impaired liver function.
In case of renal, cardiac or hepatic dysfunction, or shock, there may be greater risk
associated with the use of the veterinary medicinal product.
For maximum intramuscular injection volume per injection site see section 3.9:
administration route and dosage.
It should be noted that antagonising the levomethadone component in the veterinary
medicinal product can lead to an overhang by fenpipramide hydrochloride, which can
lead to tachycardia, for more information see section 3.10 Symptoms of overdose.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Levomethadone is an opioid and can cause respiratory depression following
accidental self-injection. Prolonged dermal exposure may also cause adverse effects.
(Levo)Methadone may harm the unborn child. The veterinary medicinal product should
not be administered by pregnant women.
Avoid skin, eye and mouth contact. In cases of spillage onto the skin, or splashing into
the eyes, wash immediately with large amounts of water. Remove contaminated
clothes.
People with known hypersensitivity to levomethadone and/or parabens should avoid
contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet to the physician but DO NOT DRIVE as sedation may occur.
ADVICE TO DOCTORS: Levomethadone is an opioid whose toxicity may cause
clinical effects including respiratory depression or apnoea, sedation, hypotension and
coma. When respiratory depression occurs controlled ventilation should be initiated.
Administration of the opioid antagonist naloxone to reverse the symptoms is
recommended.
Page 3 of 7Special precautions for the protection of the environment:
Not applicable.