Fentadon 50 Microgram/ml, Solution for Injection/Infusion for Dogs

The use of this veterinary medicinal product must be preceded by a thorough clinical
examination. Atropine may be used to block the vagal effects.
This veterinary medicinal product should be titrated for the individual animal to an
effective dose that provides adequate analgesia and minimises undesirable effects.
Animals should be carefully monitored until an effective dose is reached. Due to
individual differences in pain sensitivity, the effects of fentanyl may be variable. Older
animals may tend to titrate to a lower effective dose than younger animals.
It is important when estimating the required dose for intra-operative analgesia to
assess the likely degree of surgical stimulation, the effect of premedication drugs,
whether supportive care like endotracheal intubation and ventilatory support may be
required, and the duration of the procedure.
If other narcotic or CNS-depressant drugs (e.g. propofol, isoflurane, sevoflurane) are
used concurrently with fentanyl the doses of these agents may need to be reduced.
When estimating the required dose for post-operative analgesia the degree of tissue
damage has to be assessed.

Special precautions for safe use in the target species:
If other narcotic or CNS-depressant drugs (e.g. propofol, isoflurane, sevoflurane) are
used concurrently with fentanyl the doses of these agents may need to be reduced.
As a class, opioids, including this veterinary medicinal product, may cause
hypothermia with duration related to dose, bradypnea, hypotension and bradycardia.
Therefore, animals should be continuously monitored for rectal temperature, pulse
rate, respiratory rate and heart rhythm during surgical anaesthesia.
In case of renal, cardiac or hepatic dysfunction, hypovolaemia or shock, there may be
greater risk associated with the use of the product. It is desirable to reduce dosage in
case of hypothyroidism and in case of chronic hepatic or renal disease. As with all
narcotic analgesics, care should be taken when administering fentanyl to animals
with myasthenia gravis.
Facilities for the maintenance of a patent airway, intermittent positive pressure
ventilation (IPPV) and oxygen supplementation should be available. When respiratory
depression occurs, controlled ventilation should be installed.
As with all potent opioids, profound analgesia is accompanied by respiratory
depression, which may persist into or recur in the early post-operative period. The
respiratory depressant effects may be more problematic in animals with pre-existing
respiratory disease or increased intracranial pressure. The effect of an opioid on
head injury is dependent on the type and severity of the injury and the respiratory
support supplied. It is imperative to ensure that adequate spontaneous breathing has
AN: 03876/2023 and 03877/2023
been established and maintained before discharge from the recovery area whenever
large doses of infusions of fentanyl have been administered. The benefit/risk ratio for
using the veterinary medicinal product should be made by the attending vet. The
pharmacological effects of fentanyl citrate can be reversed by naloxone.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Fentanyl, an opioid, may cause adverse effects after internal exposure, including
respiratory depression or apnoea, sedation, hypotension and coma.
The veterinary medicinal product may cause hypersensitivity reactions. Avoid contact
with the skin and eyes. Personal protective equipment consisting of protective gloves
should be worn when handling the veterinary medicinal product. Wash hands after
use. Wash any splashes from skin and eyes immediately with large amounts of
water. Remove contaminated clothes.
Care should be taken to avoid accidental self-injection. In case of accidental self-
injection, seek medical advice immediately and show the package leaflet to the
doctor but DO NOT DRIVE as sedation may occur.
Adverse effects on the foetus cannot be excluded. Pregnant women should avoid
handling the veterinary medicinal product. In case of women who are breastfeeding
being accidentally exposed, breastfeeding is discouraged for 24 hours, as fentanyl
may transfer to breast milk.
To the physician:
Fentanyl 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 installed. Administration of the
opioid antagonist naloxone to reverse the symptoms is recommended.
Special precautions for the protection of the environment:
Not applicable.